Bill Text: CA AB1774 | 2015-2016 | Regular Session | Amended
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Clinical laboratories: licensure.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Failed) 2016-11-30 - From committee without further action. [AB1774 Detail]
Download: California-2015-AB1774-Amended.html
Bill Title: Clinical laboratories: licensure.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Failed) 2016-11-30 - From committee without further action. [AB1774 Detail]
Download: California-2015-AB1774-Amended.html
BILL NUMBER: AB 1774 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY APRIL 25, 2016
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 add Section 1272.1 to, 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,
and to repeal and add Sections 1223, 1227, and 1310 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 amended, 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. fee, and would
recast the inspection role of the department to involve inspection
and monitoring of specified issues for clinical laboratories that are
not accredited by an accrediting organization approved under CLIA,
investigation upon complaint, and sanctions, as provided. 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) 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 a clinical
laboratory in which the licensee has a membership, proprietary
interest, or coownership in any form, or has a profit-sharing
arrangement, unless the licensee at the time of making the referral
discloses in writing 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 laboratory work
or assignment performed.
(b) This does shall not apply to persons who are members of a
medical group 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 2.2 (commencing with Section 1340)
of Division 2 of the Health and Safety Code).
(c) This does shall not apply to a referral to a clinical
laboratory 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.
(d) This section does not prohibit the acceptance of evaluation
specimens for proficiency testing or referral of specimens or 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.
(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.
(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 a person licensed under this
division or under an initiative act referred to in this division, or
a clinical laboratory, or a health facility when billing for a
clinical laboratory of the facility, to charge, bill, or otherwise
solicit payment from a patient, client, or customer for 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 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 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 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) 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 a provider who has referred a patient to the clinical
laboratory in the preceding six-month period. 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 a person licensed under this division
or under any initiative act referred to in this division to charge
additional charges for 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) An itemized charge for a service actually rendered to the
patient by the licensee.
(2) 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 "a person licensed under
this division" includes a 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 registered laboratory when
the registered laboratory bills for services performed by a
laboratory owned or operated by the registered laboratory.
(e) This section does not apply to 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) This subdivision 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,
including, but not limited to, glucose, sodium, or theophylline, 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 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
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 a place used, or 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 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 clinical laboratory tests or examinations are
performed.
(13) "Physician office laboratory" means a clinical laboratory
that is either: (A) 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) 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 that
performs clinical laboratory tests 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) This chapter does not restrict, limit, or prevent 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) This chapter does not authorize 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 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 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 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 does not prohibit a clinical
laboratory from performing clinical laboratory tests or examinations
in a specialty or subspecialty for which there is no department or
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) The department shall conduct an investigation of complaints
received concerning a clinical laboratory that may include an
inspection of the laboratory.
(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 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).
(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.
SEC. 7. Section 1223 is added to the
Business and Professions Code , to read:
1223. Clinical laboratories shall choose to be overseen by the
department, pursuant to subdivision (a), or may seek certification of
deemed status by an accrediting organization approved under CLIA,
pursuant to subdivision (b). The accrediting organization may issue
certificates of deemed status and may provide continued oversight to
ensure compliance with state law.
(a) The department shall monitor, inspect, and investigate all
clinical laboratories that are not accredited by an organization
approved under CLIA for compliance with state standards that are in
excess of federal standards.
(b) (1) A clinical laboratory that is accredited by an
organization approved under CLIA shall be deemed to meet all state
standards and shall not require monitoring, inspection, or
investigation pursuant to subdivision (a), but may be subject to
investigation by the department under other provisions of law.
(2) An accrediting organization shall provide the department with
documentation of approval by the federal Centers for Medicare &
Medicaid Services as an accrediting body under CLIA, a detailed
comparison of the individual accreditation or approval requirements,
with the comparable California condition-level requirements,
including standards that are in excess of federal law, and a list of
all of the clinical laboratories that operate in California,
including the CLIA number and the expiration date of their
accreditation, as applicable.
(c) The department may concentrate its resources on upholding
personnel standards.
SEC. 7. SEC. 8. Section 1227 of the
Business and Professions Code is repealed.
SEC. 9. Section 1227 is added to the
Business and Professions Code , to read:
1227. The department shall post on its Internet Web site a
comprehensive list of the differences between state and CLIA.
SEC. 8. SEC. 10. Section 1241.1 of
the Business and Professions Code is repealed.
SEC. 9. SEC. 11. Section 1244 of the
Business and Professions Code is amended to read:
1244. This chapter does not restrict, limit, or prevent a program
of nondiagnostic general health assessment provided that:
(1) The program 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.
(10) (a) The written protocols adopted by the supervisory
committee shall be maintained for at least one year following
completion of the assessment program, during which period they shall
be subject to review by department personnel and the local health
officer or his or her designee, including the public health
laboratory director.
(b) If skin puncture to obtain a blood specimen is to be performed
in a program of nondiagnostic general health assessment, the
individual performing the skin
puncture shall be authorized to perform skin puncture under
this chapter.
(c) A program of nondiagnostic general health assessment that
fails to meet the requirements set forth in subdivisions (a) and (b)
shall not operate.
(d) For purposes of this section, "skin puncture" means the
collection of a blood specimen by the finger prick method only and
does not include venipuncture, arterial puncture, or any other
procedure for obtaining a blood specimen.
(e) This chapter 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 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 clinical laboratory participating in the health fair
shall assure that the test is ordered 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. SEC. 12. Section 1246.5 of
the Business and Professions Code is amended to read:
1246.5. (a) Notwithstanding any other law, a person may request,
and 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. 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.
(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. SEC. 13. Section 1265 of
the Business and Professions Code is repealed.
SEC. 12. SEC. 14. Section 1265.1 of
the Business and Professions Code is repealed.
SEC. 13. SEC. 15. Section 1266 of
the Business and Professions Code is repealed.
SEC. 14. SEC. 16. Section 1267 of
the Business and Professions Code is repealed.
SEC. 15. SEC. 17. Section 1268 of
the Business and Professions Code is repealed.
SEC. 16. SEC. 18. Section 1271.1 of
the Business and Professions Code is amended to read:
1271.1. (a) A clinical laboratory that provides cytology services
shall, if the laboratory ceases operation, preserve records,
reports, cytology slides, and cell blocks as prescribed in
subdivision (g) of Section 1271 and Section 1274.
(b) A person injured as a result of the laboratory's abandonment
of records may bring an action in a court of competent jurisdiction
for the amount of damages suffered as a result. If the laboratory was
a corporation or partnership 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 Section 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. SEC. 19. Section 1272 of
the Business and Professions Code is amended to read:
1272. A clinical laboratory shall participate in a 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. 20. Section 1272.1 is added to the
Business and Professions Code , to read:
1272.1. (a) If 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 section, 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.
(b) (1) Notwithstanding any other 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 by any other law, and shall maintain an ability to
provide those records when requested by the department or any duly
authorized representative of the department.
(2) 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.
(3) 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.
(4) 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.
(c) 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.
SEC. 18. SEC. 21. Section 1272.4 of
the Business and Professions Code is repealed.
SEC. 19. SEC. 22. Section 1272.6 of
the Business and Professions Code is repealed.
SEC. 20. SEC. 23. Section 1281 of
the Business and Professions Code is repealed.
SEC. 21. SEC. 24. Section 1300 of the
Business and Professions Code is amended to read:
1300. The amount of 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).
(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).
(c) The application fee for a clinical laboratory scientist's or
limited clinical laboratory scientist's license is thirty-eight
dollars ($38).
(d) The application and annual renewal fee for a cytotechnologist'
s license is fifty dollars ($50).
(e) The annual renewal fee for a clinical laboratory scientist's
or limited clinical laboratory scientist's license is twenty-five
dollars ($25).
(f) The application fee for a trainee's license is thirteen
dollars ($13).
(g) The annual renewal fee for a trainee's license is eight
dollars ($8).
(h) The application fee for a duplicate license is five dollars
($5).
(i) The personnel licensing delinquency fee is equal to the annual
renewal fee.
(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.
(k) The state, a district, city, county, city and county, or other
political subdivision, or a public officer or body shall be subject
to the payment of fees established pursuant to this chapter or
regulations adopted thereunder.
(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.
SEC. 22. SEC. 25. Section 1300.1 of
the Business and Professions Code is repealed.
SEC. 23. SEC. 26. Section 1301 of
the Business and Professions Code is amended to read:
1301. (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, if not paid before the expiration
of the fifth year of delinquency, the licensee may be subject to
reexamination.
(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 an examination shall not be required as a condition for
reinstatement if the original license was issued without an
examination. 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.
(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 (i) of Section
1300, in addition to the renewal fee in effect on the last preceding
regular renewal date. Payment of the delinquency fee is not necessary
if, within 60 days of the license expiration date, the licensee
files an application for inactive status.
SEC. 24. SEC. 27. Section 1310 of
the Business and Professions Code is repealed.
SEC. 28. Section 1310 is added to the
Business and Professions Code , to read:
1310. (a) If the department determines that a clinical laboratory
does not substantially meet the requirements of this chapter or
federal law, the department may impose any of the following:
(1) Directed plans of correction, as defined under CLIA.
(2) 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.
(3) 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 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.
(4) Onsite monitoring, as defined under CLIA, and payment for the
costs of onsite monitoring.
(5) Any combination of the actions described in paragraphs (1) to
(4), inclusive.
(b) The department or its agents may enter and inspect a clinical
laboratory at any time to enforce state laws and regulations,
including, but not limited to, state standards that are more
stringent than federal standards.
SEC. 25. SEC. 29. Section 1320 of
the Business and Professions Code is amended to read:
1320. The department may deny, suspend, or revoke a license
issued 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 or licensee of this chapter or a
rule or regulation adopted pursuant thereto.
(c) Aiding, abetting, or permitting the violation of this chapter,
the rules or regulations adopted pursuant to this chapter, or the
Medical Practice Act (Chapter 5 (commencing with Section 2000) of
Division 2).
(d) Permitting a licensed trainee to perform tests or procure
specimens unless under direct and responsible supervision.
(e) Violation of any provision of this code governing the practice
of medicine and surgery.
(f) Proof that an applicant or licensee has made false statements
in any material regard on the application for a license or renewal
issued 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 provision of
services for which a license is issued pursuant to this chapter.
(h) Proof that the applicant or licensee has used 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 an institution that, at the time the degree, certificate, or
title was 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, and the rendering of a report thereon 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 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 use impairs the ability of the
licensee to conduct, with safety to the public, the practice of
clinical laboratory technology.
(o) Misrepresentation in obtaining a license.
(p) Performance 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.
SEC. 26. SEC. 30. Section 1324 of
the Business and Professions Code is repealed.
SEC. 27. SEC. 31. Section 1325 of
the Business and Professions Code is repealed.
SEC. 28. SEC. 32. 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 the facility is licensed pursuant to Chapter 4
(commencing with Section 1600) of Division 2 of the Health and Safety
Code and any biologic, as defined in Section 9203, produced by the
facility is sold or distributed only to an establishment licensed by
this chapter or (2) to clinical laboratories whose only biologics are
autogenous bacterins prepared at the request of licensed
veterinarians.
SEC. 29. SEC. 33. 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, 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) 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 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) 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) 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) A facility licensed as a health facility under Chapter 2
(commencing with Section 1250).
(f) A freestanding clinical or pathological laboratory.
(g) A clinic operated by, or affiliated with, 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, as described in this 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. A nonprofit speech and hearing clinic desiring an exemption
under this subdivision shall 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) 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. SEC. 34. Section 1600.3 of
the Health and Safety Code is amended to read:
1600.3. "Blood bank depository" means 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. Blood
bank depositories shall be clinical laboratories, licensed in
accordance with the provisions of federal law, or other places where
services essentially equivalent are maintained, as determined by the
department.
SEC. 31. SEC. 35. 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, do not possess valid CLIA
certificates, or are not exempt 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.
