SECTIONS 1220-1228 - California Statutes

BUSINESS AND PROFESSIONS CODE

SECTION 1220-1228

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, 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 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 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) The department shall conduct an investigation of complaints
received concerning any clinical laboratory, which 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 493.1101) 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 493.1201) of Title 42 of the
Code of Federal Regulations.
(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.

1220.5. (a) The Department of Health Services shall develop, and
provide to all licensed clinical laboratories, a form in triplicate
to be used by employees, agents, and couriers of licensed clinical
laboratories to give notice when a specimen storage container has
been improperly secured pursuant to Section 681.
(b) The three copies of the triplicate form shall each contain
instructions so that one copy is to be attached to the unlocked
specimen storage container, one copy is mailed to the Department of
Consumer Affairs to be forwarded to the appropriate licensing entity
pursuant to Section 1288.3, and one copy is kept by the licensed
clinical laboratory for its records.
(c) This form shall be provided to all licensed clinical
laboratories on and after January 1, 2001.

1221. The department may employ special examiners, and may make
regulations for the conduct of examinations under this chapter.

1222. The department may approve schools that are accredited by the
National Accrediting Agency for Clinical Laboratory Sciences.

1222.5. The department may approve schools seeking to provide
instruction in clinical laboratory technic which in the judgment of
the department will provide instruction adequate to prepare
individuals to meet the requirements for licensure or performance of
duties under this chapter and regulations of the department. The
department shall establish by regulation the ratio of licensed
clinical laboratory scientists to licensed trainees on the staff of
the laboratory approved as a school and the minimum requirements for
training in any specialty or in the entire field of clinical
laboratory science or practice. Application for approval shall be
made on forms provided by the department.

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.

1224. The department may, pursuant to Chapter 3.5 (commencing with
Section 11340) of Division 3 of Title 2 of the Government Code,
adopt, amend, or repeal any regulations necessary for the
administration or enforcement of this chapter.

1224.5. The department shall conduct a study to determine whether
the persons conducting tests in physician office laboratories under
paragraph (12) of subdivision (b) of, and paragraph (10) of
subdivision (c) of Section 1206.5, produce accurate, reliable, and
necessary test results comparable to those produced by other persons
performing moderate complexity or high complexity testing, or both.

1225. (a) In order to carry out this chapter, any duly authorized
representative of the department may do any of the following:
(1) Enter or inspect on an announced or unannounced basis any
building, premise, equipment, materials, records, or information at
any reasonable time to secure compliance with, or prevent a violation
of this chapter or the regulations adopted pursuant thereto.
(2) Inspect, photograph, or copy any records, reports, test
results, test specimens, or other information related to the
requirements of this chapter or the regulations adopted pursuant
thereto.
(3) Secure any sample, photograph, or other evidence from any
building or premise for the purpose of enforcing this chapter or the
regulations adopted pursuant thereto.
(b) The department may cooperate with, or assist persons licensed
under this chapter, or other qualified persons, in evaluating
laboratory procedures and techniques necessary to achieve and
maintain high quality performance in clinical laboratories.

1226. Annually the department may compile and may thereafter
publish and sell a directory of persons within the state licensed
under the provisions of this chapter who hold unsuspended,
unforfeited and unrevoked licenses. The directory may also contain a
copy of the provisions of this chapter and regulations relating
thereto and such other information as the department may determine
advisable.

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.

1228. The department shall appoint a multidisciplinary committee to
assist, advise, and make recommendations for the establishment of
rules and regulations necessary to insure proper administration and
enforcement of the provisions of this chapter and to assist and
advise the department in matters concerning examinations for
licensees of this chapter. Appointments shall be made from lists of
nominees solicited by the department and shall provide adequate and
proper representation of all persons affected by this chapter.
Subcommittees of the committee may be appointed consisting of
committee members and consultants having particular knowledge in a
subject area for the purpose of assisting the department on special
administrative problems and in making recommendations to the
committee for consideration in the establishment of rules and
regulations. The terms of office of the members shall be determined
by the department.