BILL NUMBER: AB 1161 AMENDED
BILL TEXT
AMENDED IN SENATE AUGUST 16, 2005
AMENDED IN SENATE JUNE 20, 2005
AMENDED IN ASSEMBLY APRIL 26, 2005
INTRODUCED BY Assembly Member Niello
FEBRUARY 22, 2005
An act to amend Sections 1206, 1209, 1209.1, 1212, 1263,
1269, and 2069 of the Business and Professions Code, and to
amend Section 117995 of the Health and Safety Code, relating to
clinical laboratories, and declaring the urgency thereof, to take
effect immediately.
LEGISLATIVE COUNSEL'S DIGEST
AB 1161, as amended, Niello Unlicensed personnel:
regulation. Health regulation.
Existing law provides for the regulation and licensure of clinical
laboratories and clinical laboratory personnel by the State
Department of Health Services. Under existing law, unlicensed
personnel are authorized to perform designated duties in a clinical
laboratory under specified levels of supervision. Existing law makes
a violation of these provisions a crime.
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. The bill would make the
laboratory director responsible for assuring that results are not
reported until they have been critically reviewed and verified by
authorized personnel or by autoverification, as defined. The bill
would also require an applicant for licensure as a histocompatibility
laboratory director to successfully complete a written exam
administered by the American Board of Histcompatibility and
Immunogenetics and an oral exam administered by the department
and would specify requirements for licensure as a medical laboratory
technician and trainee .
Because the bill would revise requirements pertaining to clinical
laboratories and their personnel, a violation of which is 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.
The bill would declare that it is to take effect immediately as an
urgency statute.
Vote: 2/3. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. The Legislature hereby finds and
declares that existing law relating to the authorized duties of
laboratory personnel, particularly unlicensed laboratory personnel,
in clinical laboratories is confusing, unclear, ambiguous, and has
been outdated by modern technology. In recognition of these findings,
it is the intent of the Legislature and this act to clarify the
existing law with respect to the designated duties that laboratory
personnel are authorized to perform and to update the law to account
for the changes made by modern technology.
SECTION 1. SEC. 2. Section 1206 of
the Business and Professions Code is amended to read:
1206. (a) The following definitions apply for purposes of this
chapter:
(1) "Autoverification" means the review and verification
of clinical laboratory test or examination results with the use of a
the use of a computer algorithm when
the in conjunction with automated clinical laboratory
instrumentation to review and verify for accuracy and reliability,
the results of a clinical laboratory test or examination.
The laboratory director or a authorized
designee , who is authorized to engage in clinical
laboratory practice pursuant to this chapter has established
and validated , shall establish, validate, and doc
ument explicit criteria by which the clinical
laboratory test or examination results are verified, and a
autoverified. 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. A person authorized to perform the
applicable type and complexity of testing pursuant to Section 1206.5
is shall be physically present onsite
and in the clinical laboratory and shall be
responsible for those tests when the results are
released. Once established, the explicit criteria by which the
clinical laboratory test or examination results are verified shall be
revalidated at least annually. the accuracy and
reliability of the results of the clinical laboratory test or
examination when they are released.
(2) "Biological specimen" means any material that is derived from
the human body.
(3) "Blood electrolyte analysis" means the measurement of
electrolytes in a blood specimen by means of ion selective electrodes
on instruments specifically designed and manufactured for blood gas
and acid-base analysis.
(4) "Blood gas analysis" means a clinical laboratory test or
examination that deals with the uptake, transport, and metabolism 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 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.
(9) "General supervision" 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.
(10) "Supervision and control" means the activities of
unlicensed laboratory personnel are supervised by a physician
supervision of unlicensed 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, who is available onsite during the entire time that
unlicensed laboratory personnel are engaged in the analytical
activities specified in Section 1269. The ratio of unlicensed
laboratory personnel to a supervisor at the testing site shall not
exceed four to one. than a trainee, to perform the
applicable type and complexity of the clinical laboratory test or
examination. The supervisor shall be both physically present onsite
in the clinical laboratory and in the immediate vicinity of the
unlicensed personnel. The supervisor shall demonstrate competency in
his or her area of responsibility and provide critical evaluation of
the unlicensed laboratory personnel during the period of time that
the unlicensed laboratory personnel are engaged in activities
specified in subdivision (c) of Section 1269.
(11) "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.
(12) "Physician office laboratory" means a clinical laboratory
that is licensed or registered under Section 1265, and that is either
of the following:
(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.
(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.
(13) "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.
(14) "Specialty" means histocompatibility, microbiology,
diagnostic immunology, chemistry, hematology, immunohematology,
pathology, genetics, or other specialty specified by regulation
adopted by the department.
(15) "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
for 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.
(16) "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.
(17) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section 1265.
(18) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.
(19) "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.
(20) "Analyte" means the substance or constituent being measured
including, but not limited to, glucose, sodium, or theophyline, or
any substance or property whose presence or absence, concentration,
activity, intensity, or other characteristics are to be determined.
(21) "Analytical phase" means that part of a clinical laboratory
test or examination that commences when the biological
specimen is measured to start testing or is measured to assess
volume, or when the gynecological or pathological slide is
microscopically reviewed. The analytical phase of a
biological specimen is analyzed, measure d, 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 tests
clinical laboratory test or examination results or by
autoverification pursuant to paragraph (1).
(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. 2. SEC. 3. Section 1209 of the
Business and Professions Code is amended to read:
1209. (a) As used in this chapter, "laboratory director" means 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 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) 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 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
on 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) As part of the overall operation and administration, the
laboratory director of a clinical laboratory shall assure that
laboratory test or examination results are not reported by the
laboratory until the results have been critically reviewed and
verified for accuracy, reliability, and validity by a person
authorized to perform these tests pursuant to Section 1206.5 or by
autoverification pursuant to paragraph (1) of subdivision (a) of
Section 1206.
(h) 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. 3. SEC. 4. Section 1209.1 of
the Business and Professions Code is amended to read:
1209.1. (a) As used in this chapter "histocompatibility
laboratory director" means a person who has completed, subsequent to
graduation, four years of experience in immunology, two of which have
been in histocompatibility testing, and who meets one of the
following requirements:
(1) Is a licensed physician and surgeon.
(2) Is a bioanalyst.
(3) Has earned a doctoral degree in a biological science.
(b) In order to be eligible for licensure as a histocompatibility
laboratory director, an applicant shall provide evidence of
satisfactory performance on a written examination in
histocompatibility administered by the American Board of
Histocompatibility and Immunogenetics, and have demonstrated
satisfactory performance on an oral examination administered by the
department regarding this chapter and Part 493 (commencing with
Section 493.1) of Subchapter G of Chapter IV of Title 42 of the Code
of Federal Regulations.
(c) A person licensed under Section 1260.1 as a histocompatibility
laboratory director and qualified under CLIA may perform clinical
laboratory tests or examinations classified as of high complexity
under CLIA and the duties and responsibilities of a laboratory
director, technical consultant, clinical consultant, technical
supervisor, and general supervisor, as specified under CLIA, in the
specialty of histocompatibility, immunology, or other specialty or
subspecialty specified by regulation adopted by the department. A
person licensed as a "histocompatibility laboratory director" may
perform any clinical laboratory test or examination classified as
waived or of moderate complexity under CLIA.
SEC. 4. SEC. 5. 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 assistant who meets the requirements of
subdivision (a) of Section 1269 and who is authorized to assist in
the performance of clinical laboratory tests or examinations as
specified in subdivisions (c) and (d) of Section 1269 or unlicensed
personnel who may perform preanalytical activities and postanalytical
activities as specified in subdivision (b) of Section 1269.
(b) 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. 6. Section 1263 of the Business
and Professions Code is amended to read:
1263. (a) 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 or a medical laboratory
technician's license if those individuals meet the academic
requirements.
(b) No clinical laboratory scientist
trainee license or limited clinical laboratory scientist
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 , 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. Applicants No medical
laboratory technician trainee license shall be issued unless the
applicant 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.
(c) 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.
(d) 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.
SEC. 5. SEC. 7. Section 1269 of the
Business and Professions Code is amended to read:
1269. (a) Unlicensed laboratory personnel, as defined in Section
1212, 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 the laboratory
assistant 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 a licensed physician and
surgeon or personnel licensed under this chapter, other than
trainees, in a licensed clinical laboratory.
(C)
(B) The skills required for assisting in performing
preventive maintenance and troubleshooting of instruments.
(D)
(C) A working knowledge of reagent preparation,
stability, and storage.
(E)
(D) The skills required for assisting in the
performance of quality control procedures, and an understanding of
the quality control policies of the laboratory.
(F)
(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 prior to assignment to those duties
and responsibilities, after six months of performing those duties
and responsibilities, and
annually thereafter.
(5) Assist in the analytical phase of a clinical laboratory test
or examination or perform limited analytical activities pursuant to
subdivision (c) under supervision and control.
(6) Assist in the preanalytical phase or the postanalytical phase
of a clinical laboratory test or examination pursuant to subdivision
(b) under general supervision.
(b) Unlicensed laboratory personnel may perform the following
preanalytical and postanalytical activities under general
supervision:
(1) Biological specimen preparation, labeling, handling,
preservation or fixation, processing, transportation, and storage.
(2) Assist in preventive maintenance and troubleshooting
of instruments, including checking and cleaning equipment, replacing
components, reading thermometers, and using electronic timers.
Check and clean equipment.
(3) Preparation and storage of reagents and culture media.
(4) Preparation of automated equipment, including electronic
(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 specialty of clinical cytogenetics, assist in slide
preparation and staining, karyotype preparation, and maintenance of
backup cultures.
(8) In the specialty of genetic molecular biology, assist in
hybridization and wash procedures.
(9)
(7) In the subspecialty of cytology, accession
specimens, process specimens by staining, cover slipping, and
labeling of gynecologic and nongynecologic slides, load and
unload and loading and unloading specimens on
automated equipment or sample processors , perform equipment
maintenance, and document temperatures for quality control.
(10) (A) In the specialty of pathology, a pathologist's assistant
certified by the American Association of Pathologists' Assistants, or
an individual who otherwise qualifies under the CLIA, may perform
the following activities under the supervision and control of a
pathologist:
(i) Prepare human surgical specimens for gross description and
dissection, including description of gross features and selection of
tissues for histological examination.
(ii) Prepare and perform human postmortem examinations, including
selection of tissues and fluids for further examination.
(iii) Gather other information necessary for an autopsy report.
(iv) Prepare a body for release.
(B) A
histotechnician, certified as a histologic technician or
histotechnologist by the Board of Registry of the American Society
for Clinical Pathology or other national accrediting agency approved
by the department, may process tissues by trimming, embedding in
paraffin, or slicing. On and after January 1, 2010, an unlicensed
person who is not certified as a histologic technician or
histotechnologist by the American Society for Clinical Pathology or
other national accrediting agency approved by the department may only
do the following: accession specimens, stain, cover slip and label
slides, and perform equipment maintenance. .
(8) A histologic technician or histotechnologist who meets the
requirements specified under subdivision (a), may accession
specimens; perform maintenance of equipment; stain, cover slip, and
label slides; and process tissues by trimming, embedding in paraffin,
or slicing. On or after January 1, 2011, the department may adopt
regulations establishing qualification requirements to perform the
duties described in this paragraph.
(c) Unlicensed Unless otherwise specified,
unlicensed laboratory personnel may perform the following
limited analytical activities under supervision and control:
(1) Monitor Operate, including monitoring
electronic and mechanical performance of
, fully automated, software-directed test system analyzers,
alerting the supervisor of problems in the performance of
standards, calibrators, controls, or specimens. 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, or calibrators by use of previously
calibrated and approved automatic syringes or other
pipetting dispensers previously calibrated and approved by a
physician and surgeon or a person licensed under this chapter .
(3)
(4) Assist in performing quality control procedures.
Acceptance of parameters shall be the responsibility of a physician
and surgeon or a person licensed under this chapter.
(4)
(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.
(7) In the specialty of pathology, a pathologist's assistant
certified by the American Association of Pathologists' Assistants,
the Board of Registry of the American Society for Clinical Pathology,
or other national accrediting agency approved by the department, may
perform the following activities under the general supervision of a
pathologist:
(A) Prepare human surgical specimens for gross description and
dissection, including description of gross features and selection of
tissues for histological examination.
(B) Prepare and perform human postmortem examinations, including
selection of tissues and fluids for further examination.
(C) Gather other information necessary for an autopsy report.
(D) Prepare a body for release.
(8) (A) The following persons may prepare human surgical specimens
for gross description and dissection under the supervision and
control of a qualified pathologist, including description of gross
features and selection of tissues for histological examination, if
they meet the requirements specified in subdivision (a) and the
minimum education and training requirements for high complexity
testing personnel under CLIA:
(i) A pathologist's assistant who does not meet the certification
requirements of paragraph (7).
(ii) A histologic technician.
(iii) A histotechnologist.
(iv) A laboratory assistant, as defined in Section 1212.
(B) On or after January 1, 2011, the department may adopt
regulations establishing qualification requirements to perform the
duties described in this paragraph.
(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 personnel 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 subdivision (c).
(5) In the specialty of genetic molecular biology, process
specimens beyond initial centrifugation or perform hybridization or
wash procedures.
(4)
(6) Standardize or calibrate an instrument or assess
its performance by monitoring analy
zing results of appropriate standards
and controls, except that he or she may load standards ,
controls, or or calibrators 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) .
(5)
(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 previously calibrated and
approved automatic syringes or other dispensers
previously calibrated and approved by a licensed physician and
surgeon or a person licensed under this chapter .
SEC. 6. SEC. 8. 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 and 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 in 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 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 (8) of
subdivision (a) of Section 1206 and subdivision (a) of Section 1209.
SEC. 7. SEC. 9. 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 the 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 (8)
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).
SEC. 8. SEC. 10. 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.
SEC. 9. SEC. 11. This act is an
urgency statute necessary for the immediate preservation of the
public peace, health, or safety within the meaning of Article IV of
the Constitution and shall go into immediate effect. The facts
constituting the necessity are:
In order to promote public safety as soon as possible by revising
the provisions regulating unlicensed persons performing analytical
activities in clinical laboratories, it is necessary that this act
take effect immediately.