BILL NUMBER: AB 185 INTRODUCED
BILL TEXT
INTRODUCED BY Assembly Member Dymally
JANUARY 24, 2007
An act to amend Sections 1202, 1205, 1206, 1206.5, 1209, 1209.5,
1212, 1222.5, 1243, 1263, and 2069 of, and to repeal and add Section
1269 of, the Business and Professions Code, and to amend Section
117995 of the Health and Safety Code, relating to clinical
laboratories.
LEGISLATIVE COUNSEL'S DIGEST
AB 185, as introduced, Dymally. Clinical laboratories: personnel.
Existing law provides for the regulation and licensure of clinical
laboratories and clinical laboratory personnel by the State
Department of Health Services until June 30, 2007, and thereafter by
the State Department of Public Health. Existing law makes a violation
of these provisions a crime.
Existing law requires the department to license as trainees, as
defined, those individuals desiring to train for either a clinical
laboratory scientist's license or a limited clinical laboratory
scientist's license, providing those individuals meet specified
academic requirements.
This bill would instead specify that those individuals desiring to
train for a clinical laboratory scientist's license, a limited
clinical laboratory scientist's license, a cytotechnologist license,
or a medical laboratory technician's license shall be considered
authorized to engage in clinical laboratory practice as trainees
providing they meet specified academic requirements. The bill would
also redefine the term "trainee" for this purpose.
Existing law requires a laboratory director or a licensed
authorized designee appointed by the laboratory director to
establish, validate, and document explicit criteria by which clinical
laboratory test or examination results are autoverified, as defined.
This bill would instead require the laboratory director to assure
that laboratory test or examination results are not reported by the
clinical laboratory until the results have been either critically
reviewed and verified, as specified, by a person authorized to
perform those tests or examinations or critically reviewed and
verified by autoverification, as specified.
Under existing law, unlicensed personnel are authorized to perform
designated duties in a clinical laboratory under specified levels of
supervision.
This bill would revise the duties that unlicensed personnel are
authorized to perform in a clinical laboratory and the type of
supervision required for their performance.
This bill would define and redefine various terms and would also
make numerous technical, nonsubstantive, and conforming changes.
Because the bill would revise requirements pertaining to clinical
laboratories and their personnel, a violation of which would be a
crime, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1202 of the Business and Professions Code is
amended to read:
1202. As used in this chapter, "department" means the State
Department of Health Services Public Health
.
SEC. 2. Section 1205 of the Business and Professions Code is
amended to read:
1205. As used in this chapter, "trainee" means any person
licensed under this chapter on and before December 31, 2007, or,
on and after January 1, 2008, any person authorized, as specified in
subdivision (b) of Section 1263 for the purpose of receiving
comprehensive practical experience and instruction in clinical
laboratory procedures in one of the sciences or in general clinical
laboratory science under the direct and responsible supervision of a
person authorized to direct a laboratory under the provisions of this
chapter, clinical laboratory scientist, clinical chemist scientist,
clinical microbiologist scientist, clinical toxicologist scientist,
clinical immunohematologist scientist, clinical genetic molecular
biologist scientist, clinical cytogeneticist scientist, clinical
histocompatibility scientist, or other equivalent licensee in the
science or specialty or subspecialty for which he or she is licensed
in a clinical laboratory certified for this purpose by the department
under this chapter.
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) "Biological specimen" means any material that is derived from
the human body.
(2) "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.
(3) "Blood gas analysis" means a clinical laboratory test or
examination that deals with the uptake, transport, and metabolism of
oxygen and carbon dioxide in the human body.
(4) "Calibration or calibrate or standardization" means the
process of testing and adjusting an instrument or test system to
establish a correlation between the measurement response and the
concentration or amount of the substance that is being measured by
the test procedure.
(5) "Calibration verification" means the assaying of materials of
known concentration in the same manner as patient samples to
substantiate the instrument or test system's calibration throughout
the reportable range for patient test results.
(4)
(6) "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 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.
(5)
(7) "Clinical laboratory science" means any of the
sciences or scientific disciplines used to perform a clinical
laboratory test or examination.
(6)
(8) "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.
(7)
(9) "Clinical laboratory" means any place used, or any
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.
(8)
(10) "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. superv
ision of unlicensed laboratory personnel, as defined in
subdivision (a) of Section 1212, by a physician and surgeon or by a
person licensed under this chapter, other than a trainee, while the
unlicensed laboratory personnel are performing limited analytical
activities pursuant to subdivision (c) of Section 1269. The
supervisor shall be both physically present onsite in the clinical
laboratory and in the immediate vicinity of the unlicensed laboratory
personnel but shall not be required to provide continuous
observation. The supervisor shall meet the following requirements:
(A) Demonstrate competency in the area of activity in which the
unlicensed laboratory personnel are engaged.
(B) Perform a critical evaluation of performance as necessary to
ensure the unlicensed laboratory personnel remain competent during
the period of time the unlicensed laboratory personnel are engaged in
activities specified in subdivision (c) of Section 1269.
(C) Supervise no more than four unlicensed laboratory personnel at
a time.
(11) "Supervision and control" means that a physician and surgeon
or a person licensed under this chapter, other than a trainee, is
responsible for the conduct of unlicensed laboratory personnel and
shall be available by telephone or other electronic means, but is not
required to be present onsite during the performance of activities
by those personnel.
(9)
(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.
(10)
(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.
(11)
(14) "Public health laboratory" means a laboratory that
is operated by a city or county in conformity with Chapter
7 (commencing with Section 1000) of Part 2 of Division 1
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.
(12)
(15) "Specialty" means histocompatibility,
microbiology, diagnostic immunology, chemistry, hematology,
immunohematology, pathology, genetics, or other specialty specified
by regulation adopted by the department.
(13)
(16) "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.
(14)
(17) "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.
(15)
(18) "Licensed laboratory" means a clinical laboratory
licensed pursuant to paragraph (1) of subdivision (a) of Section
1265.
(16)
(19) "Registered laboratory" means a clinical
laboratory registered pursuant to paragraph (2) of subdivision (a) of
Section 1265.
(17)
(20) "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 CLIA.
(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.
(18)
(21) "Analyte" means the substance or constituent being
measured including, but not limited to, glucose, sodium, or
theophyline theophylline , or any substance or
property whose presence or absence, concentration, activity,
intensity, or other characteristics are to be determined.
(22) "Preanalytical phase" means that part of a clinical
laboratory test or examination that occurs before the analytical
phase begins and that is not otherwise included as part of the
analytical phase.
(23) "Analytical phase" means that part of a clinical laboratory
test or examination that commences when the biological specimen is
analyzed, measured, or examined in order to produce a clinical
laboratory test or examination result. The analytical phase of a
clinical laboratory test or examination shall end when a test or
examination result is generated, reviewed, and verified for accuracy,
reliability, and validity by a person authorized to release clinical
laboratory test or examination results or by autoverification. The
analytical phase shall include:
(A) Assessing the integrity and the adequacy or sufficiency of the
specimen to be analyzed.
(B) Test method calibration and calibration verification.
(C) Assessing the results of controls.
(24) "Postanalytical phase" means that part of a clinical
laboratory test or examination that occurs after the analytical phase
ends.
(b) Nothing in this chapter shall restrict, limit, or prevent any
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 chapter shall authorize any 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 1206.5 of the Business and Professions Code is
amended to read:
1206.5. (a) Notwithstanding subdivision (b) of Section 1206 and
except as otherwise provided in Section
Sections 1241 and 1263 , no person shall perform a
clinical laboratory test or examination classified as waived under
CLIA unless the clinical laboratory test or examination is performed
under the overall operation and administration of the laboratory
director, as described in Section 1209, including, but not limited
to, documentation by the laboratory director of the adequacy of the
qualifications and competency of the personnel, and the test is
performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or
Section 3535.
(6) A person licensed under Chapter 6 (commencing with Section
2700).
(7) A person licensed under Chapter 6.5 (commencing with Section
2840).
(8) A perfusionist if authorized by and performed in compliance
with Section 2590.
(9) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(10) A medical assistant, as defined in Section 2069, if the
waived test is performed pursuant to a specific authorization meeting
the requirements of Section 2069.
(11) A pharmacist, as defined in Section 4036, if ordering drug
therapy-related laboratory tests in compliance with clause (ii) of
subparagraph (A) of paragraph (5) of, or subparagraph (B) of
paragraph (4) of, subdivision (a) of Section 4052, or if performing
skin puncture in the course of performing routine patient assessment
procedures in compliance with Section 4052.1.
(12) Other health care personnel providing direct patient care.
(13) Any other person performing nondiagnostic testing pursuant to
Section 1244.
(b) Notwithstanding subdivision (b) of Section 1206 and
except as otherwise provided in Section 1263 , no person shall
perform clinical laboratory tests or examinations classified as of
moderate complexity under CLIA unless the clinical laboratory test or
examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or
Section 3535.
(6) A person licensed under Chapter 6 (commencing with Section
2700).
(7) A perfusionist if authorized by and performed in compliance
with Section 2590.
(8) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(9) A person performing nuclear medicine technology if authorized
by and performed in compliance with Article 6 (commencing with
Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health
and Safety Code.
(10) Any person if performing blood gas analysis in compliance
with Section 1245.
(11) (A) A person certified or licensed as an "Emergency Medical
Technician II" or paramedic pursuant to Division 2.5 (commencing with
Section 1797) of the Health and Safety Code while providing
prehospital medical care, a person licensed as a psychiatric
technician under Chapter 10 (commencing with Section 4500)
of Division 2 , as a vocational nurse pursuant to Chapter
6.5 (commencing with Section 2840), or as a midwife licensed pursuant
to Article 24 (commencing with Section 2505) of Chapter 5, or
certified by the department pursuant to Division 5 (commencing with
Section 70001) of Title 22 of the California Code of Regulations as a
nurse assistant or a home health aide, who provides direct patient
care, if the person is performing the test as an adjunct to the
provision of direct patient care by the person, is utilizing a
point-of-care laboratory testing device at a site for which a
laboratory license or registration has been issued, meets the minimum
clinical laboratory education, training, and experience requirements
set forth in regulations adopted by the department, and has
demonstrated to the satisfaction of the laboratory director that he
or she is competent in the operation of the point-of-care laboratory
testing device for each analyte to be reported.
(B) Prior to being authorized by the laboratory director to
perform laboratory tests or examinations, testing personnel
identified in subparagraph (A) shall participate in a preceptor
program until they are able to perform the clinical laboratory tests
or examinations authorized in this section with results that are
deemed accurate and skills that are deemed competent by the
preceptor. For the purposes of this section, a "preceptor program"
means an organized system that meets regulatory requirements in which
a preceptor provides and documents personal observation and critical
evaluation, including review of accuracy, reliability, and validity,
of laboratory testing performed.
(12) Any other person within a physician office laboratory if the
test is performed under the supervision of the patient's physician
and surgeon or podiatrist who shall be accessible to the laboratory
to provide onsite, telephone, or electronic consultation as needed,
and shall: (A) ensure that the person is performing test methods as
required for accurate and reliable tests; and (B) have personal
knowledge of the results of the clinical laboratory testing or
examination performed by that person before the test results are
reported from the laboratory.
(13) A pharmacist, if ordering drug therapy-related laboratory
tests in compliance with clause (ii) of subparagraph (A) of paragraph
(5) of, or subparagraph (B) of paragraph (4) of, subdivision (a) of
Section 4052.
(c) Notwithstanding subdivision (b) of Section 1206 and
except as otherwise provided in Section 1263 , no person shall
perform clinical laboratory tests or examinations classified as of
high complexity under CLIA unless the clinical laboratory test or
examination is performed under the overall operation and
administration of the laboratory director, as described in Section
1209, including, but not limited to, documentation by the laboratory
director of the adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O.
degree.
(2) A licensed podiatrist or a licensed dentist if the results of
the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical
laboratory practice or to direct a clinical laboratory if the test or
examination is within a specialty or subspecialty authorized by the
person's licensure.
(4) A person authorized to perform tests pursuant to a certificate
issued under Article 5 (commencing with Section 101150) of Chapter 2
of Part 3 of Division 101 of the Health and Safety Code if the test
or examination is within a specialty or subspecialty authorized by
the person's certification.
(5) A licensed physician assistant if authorized by a supervising
physician and surgeon in accordance with Section 3502 or
Section 3535.
(6) A perfusionist if authorized by and performed in compliance
with Section 2590.
(7) A respiratory care practitioner if authorized by and performed
in compliance with Chapter 8.3 (commencing with Section 3700).
(8) A person performing nuclear medicine technology if authorized
by and performed in compliance with Article 6 (commencing with
Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health
and Safety Code.
(9) Any person if performing blood gas analysis in compliance with
Section 1245.
(10) Any other person within a physician office laboratory if the
test is performed under the onsite supervision of the patient's
physician and surgeon or podiatrist who shall: (A) ensure that the
person is performing test methods as required for accurate and
reliable tests; and (B) have personal knowledge of the results of
clinical laboratory testing or examination performed by that person
before the test results are reported from the laboratory.
(d) Clinical laboratory examinations classified as
provider-performed microscopy under CLIA may be personally performed
using a brightfield or phase/contrast microscope by one of the
following practitioners:
(1) A licensed physician and surgeon using the microscope during
the patient's visit on a specimen obtained from his or her own
patient or from a patient of a group medical practice of which the
physician is a member or employee.
(2) A nurse midwife holding a certificate as specified by Section
2746.5, a licensed nurse practitioner as specified in Section 2835.5,
or a licensed physician assistant acting under the supervision of a
physician pursuant to Section 3502 using the microscope during the
patient's visit on a specimen obtained from his or her own patient or
from the patient of a clinic, group medical practice, or other
health care provider of which the certified nurse midwife, licensed
nurse practitioner, or licensed physician assistant is an employee.
(3) A licensed dentist using the microscope during the patient's
visit on a specimen obtained from his or her own patient or from a
patient of a group dental practice of which the dentist is a member
or an employee.
SEC. 5. Section 1209 of the Business and Professions Code is
amended to read:
1209. (a) As used in this chapter, "laboratory director" means
any a person who is a duly licensed
physician and surgeon, or is licensed to direct a clinical laboratory
under this chapter and who substantially meets the laboratory
director qualifications under CLIA for the type and complexity of
tests being offered by the laboratory. The laboratory director, if
qualified under CLIA, may perform the duties of the technical
consultant, technical supervisor, clinical consultant, general
supervisor, and testing personnel, or delegate these responsibilities
to persons qualified under CLIA. If the laboratory director
reapportions performance of those responsibilities or duties, he or
she shall remain responsible for ensuring that all those duties and
responsibilities are properly performed.
(b) (1) The laboratory director is responsible for the overall
operation and administration of the clinical laboratory, including
administering the technical and scientific operation of a clinical
laboratory, the selection and supervision of procedures, the
reporting of results, and active participation in its operations to
the extent necessary to assure compliance with this act
chapter and CLIA. He or she shall be responsible
for the proper performance of all laboratory work of all
subordinates and shall employ a sufficient number of laboratory
personnel with the appropriate education and either experience or
training to provide appropriate consultation, properly supervise and
accurately perform tests, and report test results in accordance with
the personnel qualifications, duties, and responsibilities described
in CLIA and this chapter.
(2) Where If a point-of-care
laboratory testing device is utilized and provides results for more
than one analyte, the testing personnel may perform and report the
results of all tests ordered for each analyte for which he or she has
been found by the laboratory director to be competent to perform and
report.
(c) As part of the overall operation and administration, the
laboratory director of a registered laboratory shall document the
adequacy of the qualifications (educational background, training, and
experience) of the personnel directing and supervising the
laboratory and performing the laboratory test procedures and
examinations. In determining the adequacy of qualifications, the
laboratory director shall comply with any regulations adopted by the
department that specify the minimum qualifications for personnel, in
addition to any CLIA requirements relative to the education or
training of personnel.
(d) As part of the overall operation and administration, the
laboratory director of a licensed laboratory shall do all of the
following:
(1) Ensure that all personnel, prior to testing biological
specimens, have the appropriate education and experience, receive the
appropriate training for the type and complexity of the services
offered, and have demonstrated that they can perform all testing
operations reliably to provide and report accurate results. In
determining the adequacy of qualifications, the laboratory director
shall comply with any regulations adopted by the department that
specify the minimum qualifications for, and the type of procedures
that may be performed by, personnel in addition to any CLIA
requirements relative to the education or training of personnel. Any
regulations adopted pursuant to this section that specify the type of
procedure that may be performed by testing personnel shall be based
on the skills, knowledge, and tasks required to perform the type of
procedure in question.
(2) Ensure that policies and procedures are established for
monitoring individuals who conduct preanalytical, analytical, and
postanalytical phases of testing to assure that they are competent
and maintain their competency to process biological specimens,
perform test procedures, and report test results promptly and
proficiently, and, whenever necessary, identify needs for remedial
training or continuing education to improve skills.
(3) Specify in writing the responsibilities and duties of each
individual engaged in the performance of the preanalytic,
analytic, and postanalytic preanalytical, analytical,
and postanalytical phases of clinical laboratory tests or
examinations, including which clinical laboratory tests or
examinations the individual is authorized to perform, whether
supervision is required for the individual to perform specimen
processing, test performance, or results reporting, and whether
consultant, supervisor, or director review is required prior to the
individual reporting patient test results.
(e) The competency and performance of staff of a licensed
laboratory shall be evaluated and documented by the laboratory
director, or by a person who qualifies as a technical consultant or a
technical supervisor under CLIA depending on the type and complexity
of tests being offered by the laboratory.
(1) The procedures for evaluating the competency of the staff
shall include, but are not limited to, all of the following:
(A) Direct observations of routine patient test performance,
including patient preparation, if applicable, and specimen handling,
processing, and testing.
(B) Monitoring the recording and reporting of test results.
(C) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive
maintenance records.
(D) Direct observation of performance of instrument maintenance
and function checks.
(E) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples, or external
proficiency testing samples.
(F) Assessment of problem solving skills.
(2) Evaluation and documentation of staff competency and
performance shall occur at least semiannually during the first year
an individual tests biological specimens. Thereafter, evaluations
shall be performed at least annually unless test methodology or
instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance shall be reevaluated to
include the use of the new test methodology or instrumentation.
(f) The laboratory director of each clinical laboratory of an
acute care hospital shall be a physician and surgeon who is a
qualified pathologist, except as follows:
(1) If a qualified pathologist is not available, a physician and
surgeon or a clinical laboratory bioanalyst qualified as a laboratory
director under subdivision (a) may direct the laboratory. However, a
qualified pathologist shall be available for consultation at
suitable intervals to ensure high quality service.
(2) If there are two or more clinical laboratories of an acute
care hospital, those additional clinical laboratories that are
limited to the performance of blood gas analysis, blood electrolyte
analysis, or both may be directed by a physician and surgeon
qualified as a laboratory director under subdivision (a),
irrespective of whether a pathologist is available.
As used in this subdivision, a qualified pathologist is a
physician and surgeon certified or eligible for certification in
clinical or anatomical pathology by the American Board of Pathology
or the American Osteopathic Board of Pathology.
(g) Subdivision (f) does not apply to any director of a clinical
laboratory of an acute care hospital acting in that capacity on or
before January 1, 1988.
SEC. 6. Section 1209.5 of the Business and Professions Code is
amended to read:
1209.5. (a) As part of the overall operation and
administration of a clinical laboratory, the laboratory director
shall assure that laboratory test or examination results are not
reported by the clinical laboratory until the results have been
either critically reviewed and verified for accuracy, reliability,
and validity by a person authorized to perform those tests or
examinations pursuant to Section 1206.5 or critically reviewed and
verified for accuracy, reliability, and validity by autoverification
as specified in subdivision (b).
(b) (1)
"Autoverification" means the use of a computer algorithm in
conjunction with automated clinical laboratory instrumentation to
review and verify the results of a clinical laboratory test or
examination for accuracy and reliability.
(b)
(2) The laboratory director or authorized designee
shall establish, validate, and document explicit criteria by which
the clinical laboratory test or examination results are autoverified.
(c)
(3) The laboratory director or authorized designee
shall annually revalidate the explicit criteria by which the clinical
laboratory test or examination results are autoverified. The
laboratory director shall approve and annually reapprove the computer
algorithm.
(d)
(4) An authorized designee shall
may be appointed by the laboratory director for the
purposes of this section subdivision .
The authorized designee shall be licensed to engage in clinical
laboratory practice pursuant to this chapter and shall be qualified
as a clinical consultant, technical supervisor, general supervisor,
or technical consultant pursuant to regulations adopted by the
department.
(e)
(5) A person licensed to perform the applicable type
and complexity of testing pursuant to Section 1206.5 shall be
physically present onsite in the clinical laboratory and shall have
documented competency pursuant to Section 1209 in all tests being
autoverified, and shall be responsible for the accuracy and
reliability of the results of the clinical laboratory test or
examination when the results are autoverified and reported.
SEC. 7. Section 1212 of the Business and Professions Code is
amended to read:
1212. (a) As used in this chapter, "unlicensed laboratory
personnel" means a laboratory aide, histocompatibility
technician, cardiopulmonary technician, or other person performing
the activities authorized by Section 1269 an
individual who meets the criteria of subdivision (a) of Section 1269
or a person described in Section 1269.3 .
(b) Any A person who is authorized
under California law or regulation to perform a clinical laboratory
test or examination, or to engage in clinical laboratory practice,
shall not come within the definition of "unlicensed laboratory
personnel" when performing the clinical laboratory test or
examination or engaging in the clinical laboratory practice
authorized.
SEC. 8. Section 1222.5 of the Business and Professions Code is
amended to read:
1222.5. The department may approve schools seeking to provide
instruction in clinical laboratory technic
technique 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 authorized 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. A trainee authorized to
engage in clinical laboratory practice pursuant to this chapter
shall be considered as a licensed trainee in regulations adopted by
the department. Application for approval shall be made on forms
provided by the department.
SEC. 9. Section 1243 of the Business and Professions Code is
amended to read:
1243. A An individual who is enrolled in
an approved school, as specified in Sections 1222 and 1222.5, and the
regulations promulgated thereunder, or a student regularly
matriculated in any college or university accredited by an
accrediting agency acceptable to the department, or in any legally
chartered school approved by the department for training purposes may
perform arterial puncture, venipuncture, or skin puncture as a part
of the necessary training program when done under the direct and
responsible supervision of a person licensed to perform tests under
the provisions of this chapter or a licensed physician and surgeon.
SEC. 10. Section 1263 of the Business and Professions Code is
amended to read:
1263. The (a) On and
before December 31, 2007, the department shall license as
trainees those individuals desiring to train for either a clinical
laboratory scientist's license or a limited clinical laboratory
scientist's license, providing those individuals meet the academic
requirements.
No trainee license shall be issued unless the applicant has
completed at least 90 semester hours or equivalent quarter hours of
university or college work or the essential equivalent as determined
by the department which must have included at least 23 semester hours
or equivalent quarter hours of courses in the sciences as determined
by regulations of the department. Applicants who have
completed military training schools may be granted academic credit
toward licensure by the department on the basis of recommendations
made by the American Council on Education.
Applicants shall apply for the license on forms provided by the
department and meet the requirements of this chapter and any
standards as are established by regulations of the department.
(b) On and after January 1, 2008, those individuals desiring to
train for a clinical laboratory scientist's license, a limited
clinical laboratory scientist's license, a cytotechnologist license,
or a medical laboratory technician license, who enroll in an approved
school, as specified in Sections 1222 and 1222.5 and the regulations
promulgated thereunder, shall be authorized to engage in clinical
laboratory practice as trainees pursuant to subdivision (b) of
Section 1205, providing those individuals meet the appropriate
academic requirements as specified in paragraphs (1), (2), and (3).
(1) No individual desiring to train for a clinical laboratory
scientist's license or a limited clinical laboratory scientist's
license shall engage in clinical laboratory practice as a trainee, as
specified in Section 1205, unless the individual's enrollment in an
approved school is current, and the individual has completed at least
90 semester hours or equivalent quarter hours of university or
college work, or the essential equivalent as determined by the
department, that must have included at least 23 semester hours or
equivalent quarter hours of courses in the sciences as determined by
regulations of the department.
(2) No individual desiring to train for a medical laboratory
technician license shall engage in clinical laboratory practice as a
trainee, as specified in Section 1205, unless the individual's
enrollment in an approved school is current, and the individual has
completed at least 60 semester hours or 90 quarter hours at an
accredited college or university, or the essential equivalent as
determined by the department, that includes at least 36 semester
hours or equivalent quarter hours of courses in physical or
biological sciences.
(3) No individual desiring to train for a cytotechnologist license
shall engage in clinical laboratory practice as a trainee, as
specified in Section 1205, unless the individual's enrollment in an
approved school is current.
(c) No individual shall engage in clinical laboratory practice
pursuant to subdivision (b) for more than one training enrollment
period without written authorization from the department.
(d) Individuals who have completed military training schools may
be granted academic credit toward licensure by the department on the
basis of recommendations made by the American Council on Education.
SEC. 11. Section 1269 of the Business and Professions Code is
repealed.
1269. (a) Unlicensed laboratory personnel may perform any of the
activities identified in subdivision (b), in a licensed clinical
laboratory, under the direct and constant supervision of a physician
and surgeon, or a person licensed under this chapter other than a
trainee, upon meeting all of the following criteria:
(1) Have earned a high school diploma, or its equivalent, as
determined by HCFA under CLIA.
(2) Have documentation of training appropriate to ensure that the
individual has all of the following skills and abilities:
(A) The skills required for proper specimen collection, including
patient preparation, labeling, handling, preservation or fixation,
processing or preparation, and transportation and storage of
specimens.
(B) The skills required for assisting a licensed physician and
surgeon or personnel licensed under this chapter, other than
trainees, in a licensed clinical laboratory.
(C) The skills required for performing preventive maintenance, and
troubleshooting.
(D) A working knowledge of reagent stability and storage.
(E) The skills required for assisting in the performance of
quality control procedures, and an understanding of the quality
control policies of the laboratory.
(F) An awareness of the factors that influence test results.
(b) The activities that may be performed are:
(1) Biological specimen collection, including patient preparation,
labeling, handling, preservation or fixation, processing or
preparation, and transportation and storage of specimens.
(2) Assisting a licensed physician and surgeon or personnel
licensed under this chapter, other than trainees, in a licensed
clinical laboratory.
(3) Assisting in preventive maintenance, and troubleshooting.
(4) Preparation and storage of reagents and culture media.
(5) Assisting in the performance of quality control procedures.
(c) Notwithstanding subdivision (a), unlicensed laboratory
personnel, other than a trainee, may, under the supervision and
control of a physician and surgeon or person licensed under this
chapter, perform specimen labeling, handling, preservation or
fixation, processing or preparation, transportation, and storing if
he or she meets the requirements of subparagraph (A) of paragraph (2)
of, and paragraph (1) of, subdivision (a).
(d) Unlicensed laboratory personnel shall not do any of the
following:
(1) Record test results, but he or she may transcribe results that
have been previously recorded, either manually by a physician and
surgeon or personnel licensed under this chapter, or automatically by
a testing instrument.
(2) Perform any test or part thereof that involves the
quantitative measurement of the specimen or test reagent, or any
mathematical calculation relative to determining the results or the
validity of a test procedure.
(3) Perform any phase of clinical laboratory tests or examinations
in the specialty of immunohematology beyond initial collection and
centrifugation.
(e) When any of the following manual methods are employed, the
activities of unlicensed laboratory personnel shall be limited as
follows:
(1) In the case of qualitative and semi-quantitative "spot,
tablet, or stick" tests, the personnel may add the test reagent to
the specimen or vice versa, but the results must be read by a
physician and surgeon or person licensed under this chapter.
(2) In the case of microbiological tests the unlicensed laboratory
personnel may make primary inoculations of test material onto
appropriate culture media, stain slide preparations for microscopic
examination, and subculture from liquid media.
(f) When any of the following mechanical or electronic instruments
are employed, unlicensed laboratory personnel shall not perform any
of the following activities:
(1) Standardizing or calibrating the instrument or assessing its
performance by monitoring results of appropriate standards and
control.
(2) Reading or recording test results, except that the personnel
may transcribe results that have been previously recorded
automatically by a testing instrument.
(3) Quantitatively measuring any sample or reagents unless done
automatically by the instrument in the course of its normal operation
or by the use of previously calibrated and approved automatic
syringes or other dispensers.
SEC. 12. Section 1269 is added to the Business and Professions
Code, to read:
1269. (a) Unlicensed laboratory personnel shall meet all of the
following requirements:
(1) Possess a high school diploma, or its equivalent, as specified
in regulations implementing Section 1246.
(2) Have job duties and responsibilities designated in writing by
the laboratory director.
(3) Possess documentation of training signed by the laboratory
director, technical supervisor, or technical consultant, that is
appropriate to the duties and responsibilities of unlicensed
laboratory personnel to ensure that the individual has all of the
following skills and abilities.
(A) The skills required for proper specimen preparation, labeling,
handling, preservation, staining or fixation, processing,
transportation, and storage.
(B) The skills required for assisting in performing preventive
maintenance and troubleshooting of instruments.
(C) A working knowledge of reagent preparation, stability, and
storage.
(D) The skills required for assisting in the performance of
quality control procedures, and an understanding of the quality
control policies of the laboratory.
(E) An awareness of the factors that influence test results.
(4) Provide documentation of his or her competency to perform all
job duties and responsibilities before assignment to those duties and
responsibilities, after six months of performing those duties and
responsibilities, and annually thereafter.
(5) Assist in the preanalytical phase or the postanalytical phase
of a clinical laboratory test or examination pursuant to subdivision
(b).
(6) Assist in the analytical phase of a clinical laboratory test
or examination or perform limited analytical activities pursuant to
subdivision (c).
(b) Unlicensed laboratory personnel may perform the following
preanalytical and postanalytical activities under supervision and
control:
(1) Biological specimen preparation, labeling, handling,
preservation or fixation, processing, transportation, and storage.
(2) Check and clean equipment.
(3) Preparation and storage of reagents and culture media.
(4) Electronic identification of biological specimens by barcoding
or other means, batching, loading and unloading specimens, loading
reagents, loading controls, loading standards or calibrators, and
priming equipment with reagents.
(5) In the specialty of hematology, stain slides for microscopic
review.
(6) In the specialty of microbiology, make primary inoculations of
test material onto appropriate culture media, stain slides for
microscopic review, and make subcultures from liquid media, including
blood cultures.
(7) In the subspecialty of cytology, accession specimens, process
specimens by staining, cover slipping, and labeling of gynecologic
and nongynecologic slides, and loading and unloading specimens on
automated equipment or sample processors.
(c) Unless otherwise specified, unlicensed laboratory personnel
may perform the following limited analytical activities under direct
and constant supervision:
(1) Operate fully automated, software-directed test system
analyzers, including monitoring electronic and mechanical performance
and alerting the supervisor of any problems. System adjustments
shall be performed by a physician and surgeon or a person licensed
under this chapter.
(2) Assist in preventive maintenance and troubleshooting of
instruments, including replacing components, reading thermometers,
and using electronic timers.
(3) Perform quantitative measurement of test reagents, patient
specimens, controls, standards or calibrators by use of automatic
syringes or single-volume pipetting dispensers previously calibrated
and approved by a physician and surgeon or a person licensed under
this chapter.
(4) Assist in performing quality control procedures, except the
acceptance of quality control parameters shall be the responsibility
of a physician and surgeon or a person licensed under this chapter.
(5) For qualitative and semiqualitative tests, add test reagent to
the specimen or specimen to the reagent. The results shall be read
by a physician and surgeon or a person licensed under this chapter.
(6) In the specialty of clinical cytogenetics, assist in slide
preparation and staining.
(d) Unlicensed laboratory personnel shall not do any of the
following:
(1) Record test results produced without the use of
autoverification, except an unlicensed person may transcribe or
transmit results that have been previously recorded, either manually
by a physician and surgeon or a person licensed under this chapter,
or automatically by a testing instrument, or provided by another
laboratory, when test results were reviewed and released by a person
authorized to do so by the testing laboratory.
(2) Perform any mathematical calculation relative to determining
the results or the validity of a test procedure.
(3) Perform any phase of clinical laboratory tests or examinations
in the specialty of immunohematology beyond initial collection and
centrifugation.
(4) In the specialty of clinical cytogenetics, process specimens
beyond initial centrifugation or perform staining procedures, except
as specified in paragraph (6) of subdivision (c).
(5) In the specialty of genetic molecular biology, process
specimens beyond initial centrifugation or perform hybridization or
wash procedures.
(6) Standardize or calibrate an instrument or assess its
performance by analyzing results of standards and controls, except
that he or she may load standards, calibrators, or controls as
authorized in subdivision (b) and monitor performance of fully
automated, software-directed test system analyzers, alerting the
supervisor of any problems, as authorized in subdivision (c).
(7) Quantitatively measure any sample or reagents unless done
automatically by the instrument in the course of its normal operation
or by the use of automatic syringes or other dispensers previously
calibrated and approved by a licensed physician and surgeon or a
person licensed under this chapter.
(8) Determine the integrity, adequacy or sufficiency of a
biological specimen, except the unlicensed person shall alert the
supervisor of any problems or concerns pursuant to the skills and
abilities required by subdivision (a).
SEC. 13. Section 2069 of the Business and Professions Code is
amended to read:
2069. (a) (1) Notwithstanding any other provision of law, a
medical assistant may administer medication only by intradermal,
subcutaneous, or intramuscular injections and perform skin tests and
additional technical supportive services upon the specific
authorization and supervision of a licensed physician and surgeon or
a licensed podiatrist. A medical assistant may also perform all these
tasks and services in a clinic licensed pursuant to subdivision (a)
of Section 1204 of the Health and Safety Code upon the specific
authorization of a physician assistant, a nurse practitioner, or a
nurse-midwife.
(2) The supervising physician and surgeon at a clinic described in
paragraph (1) may, at his or her discretion, in consultation with
the nurse practitioner, nurse-midwife, or physician assistant provide
written instructions to be followed by a medical assistant in the
performance of tasks or supportive services. These written
instructions may provide that the supervisory function for the
medical assistant for these tasks or supportive services may be
delegated to the nurse practitioner, nurse-midwife, or physician
assistant within the standardized procedures or protocol, and that
tasks may be performed when the supervising physician and surgeon is
not onsite, so long as the following apply:
(A) The nurse practitioner or nurse-midwife is functioning
pursuant to standardized procedures, as defined by Section 2725, or
protocol. The standardized procedures or protocol shall be developed
and approved by the supervising physician and surgeon, the nurse
practitioner or nurse-midwife, and the facility administrator or his
or her designee.
(B) The physician assistant is functioning
pursuant to regulated services defined in Section 3502 and is
approved to do so by the supervising physician or surgeon.
(b) As used in this section and Sections 2070 and 2071, the
following definitions shall apply:
(1) "Medical assistant" means a person who may be unlicensed, who
performs basic administrative, clerical, and technical supportive
services in compliance with this section and Section 2070 for a
licensed physician and surgeon or a licensed podiatrist, or group
thereof, for a medical or podiatry corporation, for a physician
assistant, a nurse practitioner, or a nurse-midwife as provided in
subdivision (a), or for a health care service plan, who is at least
18 years of age, and who has had at least the minimum amount of hours
of appropriate training pursuant to standards established by the
Division of Licensing. The medical assistant shall be issued a
certificate by the training institution or instructor indicating
satisfactory completion of the required training. A copy of the
certificate shall be retained as a record by each employer of the
medical assistant.
(2) "Specific authorization" means a specific written order
prepared by the supervising physician and surgeon or the supervising
podiatrist, or the physician assistant, the nurse practitioner, or
the nurse-midwife as provided in subdivision (a), authorizing the
procedures to be performed on a patient, which shall be placed in the
patient's medical record, or a standing order prepared by the
supervising physician and surgeon or the supervising podiatrist, or
the physician assistant, the nurse practitioner, or the nurse-midwife
as provided in subdivision (a), authorizing the procedures to be
performed, the duration of which shall be consistent with accepted
medical practice. A notation of the standing order shall be placed on
the patient's medical record.
(3) "Supervision" means the supervision of procedures authorized
by this section by the following practitioners, within the scope of
their respective practices, who shall be physically present in the
treatment facility during the performance of those procedures:
(A) A licensed physician and surgeon.
(B) A licensed podiatrist.
(C) A physician assistant, nurse practitioner, or nurse-midwife as
provided in subdivision (a).
(4) "Technical supportive services" means simple routine medical
tasks and procedures that may be safely performed by a medical
assistant who has limited training and who functions under the
supervision of a licensed physician and surgeon or a licensed
podiatrist, or a physician assistant, a nurse practitioner, or a
nurse-midwife as provided in subdivision (a).
(c) Nothing in this section shall be construed as authorizing the
licensure of medical assistants. Nothing in this section shall be
construed as authorizing the administration of local anesthetic
agents by a medical assistant. Nothing in this section shall be
construed as authorizing the division to adopt any regulations that
violate the prohibitions on diagnosis or treatment in Section 2052.
(d) Notwithstanding any other provision of law, a medical
assistant may not be employed for inpatient care in a licensed
general acute care hospital as defined in subdivision (a) of Section
1250 of the Health and Safety Code.
(e) Nothing in this section shall be construed as authorizing a
medical assistant to perform any clinical laboratory test or
examination for which he or she is not authorized by Chapter 3
(commencing with Section 1206.5) 1200)
. Nothing in this section shall be construed as authorizing a nurse
practitioner, nurse-midwife, or physician assistant to be a
laboratory director of a clinical laboratory, as those terms are
defined in paragraph (7) (9) of
subdivision (a) of Section 1206 and subdivision (a) of Section 1209.
SEC. 14. Section 117995 of the Health and Safety Code is amended
to read:
117995. The registration and annual permit fee for large quantity
generators shall be set in following amounts:
(a) (1) A general acute care hospital, as defined in subdivision
(a) of Section 1250, that has one or more beds, but not more than 99
beds, shall pay six hundred dollars ($600), a facility with 100 or
more beds, but not more than 199 beds, shall pay eight hundred sixty
dollars ($860), a facility with 200 or more beds, but not more than
250 beds shall pay one thousand one hundred dollars ($1,100), and a
facility with 251 or more beds shall pay one thousand four hundred
dollars ($1,400).
(2) In addition to the fees specified in paragraph (1), a general
acute care hospital which is providing onsite treatment of medical
waste shall pay an annual medical waste treatment facility inspection
and permit fee of three hundred dollars ($300), if the facility has
one or more beds but not more than 99 beds, five hundred dollars
($500), if the facility has 100 or more beds but not more than 250
beds, and one thousand dollars ($1,000), if the facility has 251 or
more beds.
(b) A specialty clinic, providing surgical, dialysis, or
rehabilitation services, as defined in subdivision (b) of Section
1204, shall pay three hundred fifty dollars ($350).
(c) A skilled nursing facility, as defined in subdivision (c) of
Section 1250, that has one or more beds, but not more than 99 beds
shall pay two hundred seventy-five dollars ($275), a facility with
100 or more beds, but not more than 199 beds shall pay three hundred
fifty dollars ($350), and a facility with 200 or more beds shall pay
four hundred dollars ($400).
(d) An acute psychiatric hospital, as defined in subdivision (b)
of Section 1250, shall pay two hundred dollars ($200).
(e) An intermediate care facility, as defined in subdivision (d)
of Section 1250, shall pay three hundred dollars ($300).
(f) A primary care clinic, as defined in Section 1200.1, shall pay
three hundred fifty dollars ($350).
(g) A licensed clinical laboratory, as defined in paragraph
(3) (9) of subdivision (a) of Section
1206 of the Business and Professions Code, shall pay two hundred
dollars ($200).
(h) A health care service plan facility, as defined in subdivision
(f) of Section 1345, shall pay three hundred fifty dollars ($350).
(i) A veterinary clinic or veterinary hospital shall pay two
hundred dollars ($200).
(j) A large quantity generator medical office shall pay two
hundred dollars ($200).
(k) In addition to the fees specified in subdivisions (b) to (j),
inclusive, a large quantity generator of medical waste which is
providing onsite treatment of medical waste shall pay an annual
medical waste treatment facility inspection and permit fee of three
hundred dollars ($300).
(l) The department may collect annual fees and issue permits on a
biennial basis.
SEC. 15. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.