BILL NUMBER: SB 289 ENROLLED
BILL TEXT
PASSED THE SENATE AUGUST 30, 2012
PASSED THE ASSEMBLY AUGUST 27, 2012
AMENDED IN ASSEMBLY AUGUST 23, 2012
AMENDED IN ASSEMBLY AUGUST 6, 2012
AMENDED IN ASSEMBLY JUNE 19, 2012
AMENDED IN SENATE JANUARY 4, 2012
AMENDED IN SENATE MARCH 24, 2011
INTRODUCED BY Senator Hernandez
FEBRUARY 14, 2011
An act to amend Sections 1206, 1222.5, and 2069 of the Business
and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
SB 289, Hernandez. Clinical laboratory techniques: training and
instruction.
Existing law provides for the licensure and regulation of clinical
laboratories and various clinical laboratory health care
professionals by the State Department of Public Health. Existing law
authorizes the department to approve schools seeking to provide
instruction in clinical laboratory techniques, as specified.
This bill would authorize the department to approve specified
institutions seeking to provide clinical laboratory scientist
programs for instruction in clinical laboratory techniques, as
specified, including, among others, a California licensed clinical
laboratory and an accredited college or university in the United
States. The bill would also specify that, upon approval by the
department, clinical laboratory scientist programs may use multiple
clinical laboratories apportioned in any percentage to provide
training in clinical laboratory techniques, if specified conditions
are met.
The bill would also make technical, nonsubstantive changes to
these provisions.
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 following
definitions are applicable:
(1) "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.
(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
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.
(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) "Direct and constant supervision" means personal observation
and critical evaluation of the activity of unlicensed laboratory
personnel by a physician and surgeon, or by a person licensed under
this chapter other than a trainee, during the entire time that the
unlicensed laboratory personnel are engaged in the duties specified
in Section 1269.
(10) "Direct and responsible supervision" means both of the
following:
(A) Personal observation and critical evaluation of the activity
of a trainee by a physician and surgeon, or by a person licensed
under this chapter other than a trainee, during the entire time that
the trainee is performing clinical laboratory tests or examinations.
(B) Personal review by the physician and surgeon or the licensed
person of all results of clinical laboratory testing or examination
performed by the trainee for accuracy, reliability, and validity
before the results are reported from the laboratory.
(11) "Licensed laboratory" means a clinical laboratory licensed
pursuant to paragraph (1) of subdivision (a) of Section 1265.
(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.
(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.
(14) "Point-of-care laboratory testing device" means a portable
laboratory testing instrument to which the following applies:
(A) It is used within the proximity of the patient for whom the
test or examination is being conducted.
(B) It is used in accordance with the patient test management
system, the quality control program, and the comprehensive quality
assurance program established and maintained by the laboratory
pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C) It meets the following criteria:
(i) Performs clinical laboratory tests or examinations classified
as waived or of moderate complexity under the federal Clinical
Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec.
263a).
(ii) Performs clinical laboratory tests or examinations on
biological specimens that require no preparation after collection.
(iii) Provides clinical laboratory tests or examination results
without calculation or discretionary intervention by the testing
personnel.
(iv) Performs clinical laboratory tests or examinations without
the necessity for testing personnel to perform calibration or
maintenance, except resetting pursuant to the manufacturer's
instructions or basic cleaning.
(15) "Public health laboratory" means a laboratory that is
operated by a city or county in conformity with Article 5 (commencing
with Section 101150) of Chapter 2 of Part 3 of Division 101 of the
Health and Safety Code and the regulations adopted thereunder.
(16) "Registered laboratory" means a clinical laboratory
registered pursuant to paragraph (2) of subdivision (a) of Section
1265.
(17) "Specialty" means histocompatibility, microbiology,
diagnostic immunology, chemistry, hematology, immunohematology,
pathology, genetics, or other specialty specified by regulation
adopted by the department.
(18) "Subspecialty" for purposes of microbiology, means
bacteriology, mycobacteriology, mycology, parasitology, virology,
molecular biology, and serology for diagnosis of infectious diseases,
or other subspecialty specified by regulation adopted by the
department; for purposes of diagnostic immunology, means syphilis
serology, general immunology, or other subspecialty specified by
regulation adopted by the department; for purposes of chemistry,
means routine chemistry, clinical microscopy, endocrinology,
toxicology, or other subspecialty specified by regulation adopted by
the department; for purposes of immunohematology, means ABO/Rh Type
and Group, antibody detection for transfusion, antibody detection
nontransfusion, antibody identification, compatibility, or other
subspecialty specified by regulation adopted by the department; for
pathology, means tissue pathology, oral pathology, diagnostic
cytology, or other subspecialty specified by regulation adopted by
the department; for purposes of genetics, means molecular biology
related to the diagnosis of human genetic abnormalities,
cytogenetics, or other subspecialty specified by regulation adopted
by the department.
(b) 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 1222.5 of the Business and Professions Code is
amended to read:
1222.5. (a) The department may approve any of the following
seeking to provide clinical laboratory scientist programs for
instruction in clinical laboratory technique that, 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:
(1) A California licensed clinical laboratory.
(2) An accredited college or university in the United States of
America.
(3) A United States military medical laboratory specialist program
of at least 52 weeks duration.
(4) A laboratory owned and operated by the United States
government.
(b) Upon approval by the department, clinical laboratory scientist
programs approved by the department may use multiple clinical
laboratories to provide training in clinical laboratory technique,
provided the following conditions are met:
(1) The program may apportion the clinical training among multiple
clinical laboratories in any percentage as long as the total
training meets the requirements established by the department.
(2) Each clinical laboratory has been approved by the department
as part of the program in accordance with regulations. The program
shall notify the department in writing within 30 days of a change in
clinical laboratories used by the program to provide training.
(3) The director of the approved program shall be responsible for
notifying the department in advance of the start and end date of
training for each trainee. The program shall coordinate with the
department in meeting established requirements.
(4) The director of the approved program shall ensure that all of
the department's requirements for training and affiliation are met.
(5) The program has submitted an application on forms provided by
the department for approval.
(c) The department shall establish by regulation the ratio of
licensed clinical laboratory scientists to licensed trainees on the
staff of the clinical laboratory and the minimum requirements for
training in any specialty or in the entire field of clinical
laboratory science or practice. Application for approval shall be
made on forms provided by the department.
SEC. 3. 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). 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.