BILL NUMBER: AB 1161 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 20, 2005
AMENDED IN ASSEMBLY APRIL 26, 2005
INTRODUCED BY Assembly Member Niello
FEBRUARY 22, 2005
An act to add Section 10131.02 to the Business and
Professions Code, relating to real estate brokers. An
act to amend Sections 1206, 1209, 1209.1, 1212, 1269, and 2069 of the
Business and Professions Code, and to amend Section 117995 of the
Health and Safety Code, relating t o clinical
laboratories, and declaring the urgency thereof, to take effect
immediately.
LEGISLATIVE COUNSEL'S DIGEST
AB 1161, as amended, Niello. Real estate brokers.
Unlicensed personnel: 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.
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.
Under existing law, the Real Estate Law, the Department of Real
Estate licenses and regulates persons engaged in the business of a
real estate broker. Existing law defines a real estate broker as a
person who performs specified acts for another relating to, among
other things, loans secured by real property.
This bill would authorize a loan made, arranged, or transferred by
or through a real estate broker to be secured by certain types of
personal property incidental to the real property security.
Vote: majority 2/3 . Appropriation:
no. Fiscal committee: no yes .
State-mandated local program: no yes .
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1206 of the Business
and Professions Code is amended to read:
1206.
(a) For the purposes of this chapter the
The following definitions are applicable
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
computer algorithm when the laboratory director or a designee
authorized to engage in clinical laboratory practice
pursuant to this chapter has established and validated explicit
criteria by which the clinical laboratory test or examination results
are verified, and a person authorized to perform the applicable type
and comple xity of testing pursuant to Section 1206.5 is
present onsite and 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.
(2) "Biological specimen" means any material
that is derived from the human body.
(2)
(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.
(3)
(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.
(4)
(5) "Clinical laboratory test or examination" means the
detection, identification, measurement, evaluation, correlation,
monitoring, and reporting of any particular analyte, entity, or
substance within a biological specimen for the purpose of obtaining
scientific data which that may be used
as an aid to ascertain the presence, progress, and source of a
disease or physiological condition in a human being, or used as an
aid in the prevention, prognosis, monitoring, or treatment of a
physiological or pathological condition in a human being, or for the
performance of nondiagnostic tests for assessing the health of an
individual.
(5)
(6) "Clinical laboratory science" means any of the
sciences or scientific disciplines used to perform a clinical
laboratory test or examination.
(6)
(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.
(7)
(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.
(8) "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.
(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, but is not required to be present during the performance
of activities by those personnel.
(10) "Supervision and control" means
the activities of unlicensed laboratory personnel are supervised 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.
(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.
(10)
(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
(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 .
(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)
(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 7
(commencing with Section 1000) 2 of Part
2 3 of Division 1
101 of the Health and Safety Code and the regulations
adopted thereunder.
(12)
(14) "Specialty" means histocompatibility,
microbiology, diagnostic immunology, chemistry, hematology,
immunohematology, pathology, genetics, or other specialty specified
by regulation adopted by the department.
(13)
(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
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)
(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.
(15)
(17) "Licensed laboratory" means a clinical laboratory
licensed pursuant to paragraph (1) of subdivision (a) of Section
1265.
(16)
(18) "Registered laboratory" means a clinical
laboratory registered pursuant to paragraph (2) of subdivision (a) of
Section 1265.
(17)
(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.
(18)
(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 clinical laboratory test or examination
shall end when a test result is generated, reviewed, and verified for
accuracy, reliability, and validity by a person authorized to
release tests 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. 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 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 on 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. 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 any
a person who is (a) a duly licensed physician,
(b) a bioanalyst, or (c) a person who has earned a doctoral degree in
a biological science and 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. 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 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) 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. 5. Section 1269 of the Business
and Professions Code is amended to read:
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 ,
as defined in Section 1212, shall meet all of the following
requirements :
(1) Have earned Possess a high
school diploma, or its equivalent, as determined by HCFA
under CLIA specified in regulations implementing
Section 1246 .
(2) Have documentation of training appropriate
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 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 assisting in performing
preventive maintenance , and troubleshooting
of instruments .
(D) A working knowledge of reagent preparation,
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.
(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) The activities that may be performed are
Unlicensed laboratory personnel may perform the following
preanalytical and postanalytical activities under general
supervision :
(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 Assist in
preventive maintenance and troubleshooting of instruments, including
checking and cleaning equipment, replacing components, reading
thermometers, and using electronic timers .
(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).
(4) Preparation of automated equipment, including 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) In the subspecialty of cytology, accession specimens, process
specimens by staining, cover slipping, and labeling of gynecologic
and nongynecologic slides, load and unload 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.
(c) Unlicensed laboratory personnel may perform the following
limited analytical activities under supervision and control:
(1) Monitor performance of fully automated, software-directed test
system analyzers, alerting the supervisor of problems in the
performance of standards, calibrators, controls, or specimens. System
adjustments shall be performed by a physician and surgeon or a
person licensed under this chapter.
(2) Perform quantitative measurement of test reagents, patient
specimens, or calibrators by use of previously calibrated and
approved automatic syringes or other pipetting dispensers.
(3) 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) 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.
(d) Unlicensed laboratory personnel shall not do any of the
following:
(1) Record test results , but he or she
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 laboratory .
(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
(4) Standardize or calibrate an
instrument or assessing assess its
performance by monitoring results of appropriate standards and
control controls, except that he or she may
load standards or calibrators as authorized in subdivision
(b) .
(2) Reading or recording test results, except that the personnel
may transcribe results that have been previously recorded
automatically by a testing instrument.
(3)
(5) Quantitatively measuring
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.
SEC. 6. 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) (8) of
subdivision (a) of Section 1206 and subdivision (a) of Section 1209.
SEC. 7. 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) (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.
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.
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.
SECTION 1. Section 10131.02 is added to the Business and
Professions Code, to read:
10131.02.
(a) A loan made, arranged, or transferred by or through a real
estate broker under subdivision (d) or (e) of Section 10131 may be
additionally secured by personal property incidental to the real
property security, provided the personal property security consists
of one or more of the following:
(1) Assignments of rents and profits.
(2) Cash collateral to be disbursed through construction loan
agreements executed by the borrower and the lender.
(3) Building and site plans and specifications, including
contracts with design professionals.
(4) Construction contracts with a builder who is a licensed
general contractor.
(5) Building permits issued by the political subdivision having
jurisdiction over the matter.
(6) Any other personal property specifically related to the
construction of building and site improvements or to the ownership
and operation of the real property security that constitutes
collateral security incidental to the real property security.
(b) The value of additional personal property security as
described in subdivision (a), other than cash collateral, may not be
included in estimating the fair market value of the underlying real
property security or for calculating the loan to value ratio as
required by subdivision (h) of Section 10238.