BILL ANALYSIS Ó
AB 757
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Date of Hearing: April 28, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 757
(Gomez) - As Amended March 26, 2015
SUBJECT: Healing arts: clinical laboratories.
SUMMARY: Authorizes a medical assistant, who meets specified
criteria, to perform a total protein refractometer test analysis
in a licensed plasma collection facility in this state.
EXISTING FEDERAL LAW:
1)Regulates laboratory testing and requires that clinical
laboratories obtain a certificate before accepting materials
derived from the human body for the purpose of providing
information for the diagnosis, prevention, or treatment of any
disease or the impairment of, or assessment of the health of
human beings. (Clinical Laboratory Improvement Amendments
(CLIA), Title 42 United States Code (USC) § 263a)
2)Classifies laboratory tests using three categories: "waived
tests," "moderate complexity," or "high complexity." (Title 42
Code of Federal Regulations (CFR) § 493.5)
3)Defines "waived tests" as simple laboratory examinations and
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procedures which: 1) are cleared by Federal Food and Drug
Administration (FDA) for home use; 2) employ methodologies
that are so simple and accurate as to render the likelihood of
erroneous results negligible; or 3) pose no reasonable risk of
harm to the patient if the test is performed incorrectly. (42
CFR § 493.15)
4)Specifies nine types of tests that are automatically
categorized as waived: 1) various dipstick or tablet reagent
urinalysis (non-automated), including protein; 2) fecal occult
blood; 3) ovulation tests-visual color comparison tests; 4)
urine pregnancy tests-visual color comparison tests; 5)
erythrocyte sedimentation rate-non-automated; 6)
hemoglobin-copper sulfate-non-automated; 7) blood glucose by
glucose monitoring devices cleared by the FDA specifically for
home use; 8) spun microhematocrit; and 9) hemoglobin by single
analyte instruments with self-contained or component features
to perform specimen/reagent interaction, providing direct
measurement and readout. (42 CFR § 493.15)
5)Requires laboratories to ensure that each individual
performing moderate complexity testing possesses a current
license issued by the state where laboratory is located, if a
license is required, and meet one of the following
requirements: (42 CFR § 493.1423)
a) Be a doctor of medicine or doctor of osteopathy licensed
to practice medicine or osteopathy in the State in which
the laboratory is located or have earned a doctoral,
master's, or bachelor's degree in a chemical, physical,
biological or clinical laboratory science, or medical
technology from an accredited institution.
b) Have earned an associate degree in a chemical, physical
or biological science or medical laboratory technology from
an accredited institution.
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c) Be a high school graduate or equivalent and have
successfully completed an official military medical
laboratory procedures course of at least 50 weeks duration
and have held the military enlisted occupational specialty
of Medical Laboratory Specialist (Laboratory Technician).
d) Have earned a high school diploma or equivalent, and
have documentation of training appropriate for the testing
performed prior to analyzing patient specimens.
6)Defines a refractometer as a device used to determine the
amount of solute in a solution by measuring the index of
refraction (the ratio of the velocity of light in a vacuum to
the velocity of light in the solution). The index of
refraction is used to measure the concentration of certain
analytes (solutes), such a plasma total proteins and urinary
total solids. Measurements obtained by this device are used in
the diagnosis and treatment of certain conditions. (21 CFR §
862.2800(a))
EXISTING STATE LAW:
7)Provides for the licensure, registration, and regulation of
clinical laboratories and various clinical laboratory
personnel by the California Department of Public Health
(CDPH), with specified exceptions. (BPC § 1200-1327)
8)Prohibits a person from performing a test classified as of
moderate complexity test under CLIA unless the test is
performed under a laboratory director, as described in BPC §
1209, the laboratory director provides documentation of the
adequacy of the qualifications and competency of the
personnel, and the test is performed by any of the following
individuals: (BPC § 1206.5)
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a) A licensed physician and surgeon;
b) A licensed podiatrist or a licensed dentist;
c) A person licensed to engage in clinical laboratory
practice or to direct a clinical laboratory;
d) A certified local health officer;
e) A licensed physician assistant if authorized by a
supervising physician and surgeon;
f) A registered nurse;
g) A perfusionist if authorized under BPC § 2590;
h) A respiratory care practitioner;
i) A person certified to perform nuclear medicine
technology under CDPH;
j) Any person if performing blood gas analysis in
compliance with BPC § 1245;
aa)A certified or licensed emergency medical technician II or
paramedic while providing prehospital medical care; and,
bb)A person licensed as a psychiatric technician, as a
vocational nurse, or as a licensed midwife, or certified by
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the CDPH as a nurse assistant or a home health aide, who
provides direct patient care, if the person meets the
following:
i) Is performing the test as an adjunct to the
provision of direct patient care by the person;
ii)Is utilizing a point-of-care laboratory testing device
at a site for which a laboratory license or registration
has been issued;
iii)Meets the minimum clinical laboratory education,
training, and experience requirements set forth in
regulations adopted by the CDPH; and,
iv)Has demonstrated to the satisfaction of the laboratory
director that the person is competent in the operation of
the point-of-care laboratory testing device for each
analyte to be reported.
cc)Any person within a physician office laboratory if the
test is performed under the supervision of the patient's
physician and surgeon or podiatrist who is accessible to
the laboratory to provide onsite, telephone, or electronic
consultation as needed, and meets the following:
i) Ensures that the person is performing test methods
as required for accurate and reliable tests; and
ii)Has personal knowledge of the results of the clinical
laboratory testing or examination performed by that
person before the test results are reported from the
laboratory.
dd)A pharmacist, if ordering drug therapy-related laboratory.
9)Authorizes a medical assistant to do the following: (BPC §
2069)
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a) Administer medication through intradermal, subcutaneous,
or intramuscular injections; and,
b) 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 upon the specific authorization of a physician
assistant, a nurse practitioner, or a certified
nurse-midwife.
10) Defines a
"medical assistant" as a person who may be unlicensed who
meets the following: (BPC § 2029(b)(1))
a) Performs basic administrative, clerical, and technical
supportive services for a licensed physician and surgeon, a
licensed podiatrist, a medical or podiatry corporation, a
physician assistant, a nurse practitioner, or a certified
nurse-midwife, or a health care service plan;
b) At least 18 years of age; and,
c) Has had at least the minimum amount of hours of
appropriate training pursuant to standards established by
the Medical Board.
11) Defines
"specific authorization" as a specific written order or a
standing order prepared by the supervising physician and
surgeon, podiatrist, physician assistant, nurse practitioner,
or certified nurse-midwife, authorizing the procedures to be
performed on a patient. (BPC § 2069(b)(2))
12) Defines
"supervision" as 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: (BPC § 2069(b)(3))
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a) A licensed physician and surgeon;
b) A licensed podiatrist; and,
c) A physician assistant, nurse practitioner, or certified
nurse-midwife as provided in subdivision (a).
13) Defines
"technical supportive services" as 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, a licensed
podiatrist, a physician assistant, a nurse practitioner, or a
certified nurse-midwife. (BPC § 2069(b)(4))
THIS BILL:
14)
Authorizes a medical assistant, as defined in BPC § 2069, to perform a
total protein refractometer test analysis in a licensed plasma
collection facility in this state if all of the following
conditions are met:
a) The medical assistant has earned a high school diploma
or equivalent, as determined by Health Care Financing
Administration (HCFA) under CLIA.
b) The medical assistant performs the total protein
refractometer test analysis in a licensed plasma collection
facility.
c) The medical assistant been instructed by a physician and
surgeon licensed in this state or by a licensed clinical
laboratory director who is in charge of the licensed plasma
collection facility in the proper procedure to be employed
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when performing a total protein refractometer test
analysis.
d) The medical assistant performs the total protein
refractometer test analysis under the direction and
supervision of the physician and surgeon or licensed
clinical laboratory director.
e) The medical assistant submits the analysis for
interpretation to the physician and surgeon or licensed
clinical laboratory director under whose direction and
supervision he or she performed the analysis.
15) States
that no reimbursement is required pursuant to Section 6 of
Article XIII B of
the California Constitution, as specified.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS:
16)Purpose. This bill is sponsored by Grifols, Inc . According
to the author, "Plasma donation centers are critical to
ensuring the availability of therapies that treat rate,
chronic, and sometimes life-threatening diseases. AB 757 would
authorize a medical assistant who meets specified criteria to
perform a total protein refractometer test analysis - a
standard, mostly automated procedure performed during donor
intake and assessment to determine donor eligibility - in
state licensed plasma collection facility in California. This
will help promote efficiencies, where appropriate, in the
biomedical industry while continuing to prioritize patient
health and safety."
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17)Background. At the federal level, laboratories that perform
tests on human specimens are certified under CLIA. The
requirements for CLIA certification vary depending on the
complexity of the laboratory tests performed. Clinical
laboratories or other testing sites need to know whether a
test system is waived, moderate or high complexity for each.
In general, the more complicated the test, the more stringent
the requirements under CLIA.
As defined by CLIA, waived tests are simple tests with a low
risk for an incorrect result. They include certain tests
listed in the CLIA regulations, tests cleared by the FDA for
home use, and tests approved for waiver by the FDA using the
CLIA criteria.
Tests not classified as waived are assigned a moderate or high
complexity category on the basis of seven criteria given in
the CLIA regulations. For commercially available FDA-cleared
or approved tests, the test complexity is determined by the
FDA during the pre-market approval process.
In California, anyone may perform a waived test in a licensed
laboratory. However, only licensed or certified individuals
may perform moderate complexity tests, for instance, a medical
laboratory technologist (MLT) under BPC § 1260.3. There is
are two exceptions for unlicensed individuals to perform a
moderate complexity test in California, and that is for a
blood gas analysis under BPC § 1245 and anyone in a
physician's office laboratory with a physician readily
available. Because medical assistants are unlicensed and
there is no exception for them, they cannot perform moderate
or high complexity tests.
Total Protein Refractometer Test. According to the sponsors,
Grifols measures a potential plasma donor's total protein
levels as part of the initial screening process. In general,
the measurement of total protein uses an instrument called a
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refractometer. A refractometer is a device that shines a beam
of light through a sample of liquid. The device measures the
amount of light that is refracted (bent) due to the solids in
the sample. In blood, protein causes light to bend. The
greater the amount of protein, the more light is bent from the
light path.
There are multiple types of protein refractometer devices,
ranging from manual to automatic and digital. However, the
FDA's medical device database shows that the FDA has
classified all total protein refractometer devices as of
moderate complexity under CLIA.
There are other types of devices that can measure total protein,
such as chemical analyzers using whole blood. The FDA has
classified most of the whole blood chemical analyzers as
waived.
CLIA Waiver by Application. The sponsor points out that the
type of refractometer device it uses to perform total protein
tests is very simple to use and does not require special
training. However, because the device is so simple to use, it
is unclear why it was not classified as waived. Further, it
is unclear why the manufacturer did not try to obtain a waiver
by application. The sponsor believes that there was no
financial incentive.
A manufacturer may submit a CLIA waiver by application if it
thinks the FDA has mistakenly categorized the test. For
example, if the FDA initially categorized a test as moderately
complex, but the manufacturer believes the test is simple to
use, it may submit a CLIA waiver by application to request
re-categorization as waived.
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A CLIA waiver by application must demonstrate in clinical
studies conducted at the intended use sites that the test is
accurate and poses little to no risk of incorrect results. It
must also include the following information:
a) A description of the device that demonstrates it is
simple to use.
b) The results of risk analysis including the
identification of potential sources of error for your
device.
c) The results of flex studies demonstrating insensitivity
of the test system to environmental and usage variations
under conditions of stress.
d) The results of risk evaluation and control including a
description of (1) measures you have implemented to
mitigate the risk of errors, and (2) validation and/or
verification studies demonstrating the ability of failure
alert, fail-safe mechanisms, and other control measures
that you have incorporated into your device to mitigate the
risk of errors, even under conditions of stress.
e) A description of the design and results of clinical
studies you conducted to demonstrate that the device has an
insignificant risk of erroneous results in the hands of the
intended user (hereinafter operator).
f) Proposed labeling with instructions for use consistent
with a device that is "simple."
ARGUMENTS IN SUPPORT:
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Grifols, Inc. (sponsor) writes in support, "a total protein
refractometer test can be administered in 48 states by a trained
healthcare professional equivalent to what California defines as
a medical assistant. However, California law does not authorize
this simple, almost entirely automated test to be conducted by a
highly trained and supervised medical assistant at a licensed
plasma donation center.
AB 757 represents a minor expansion in the tasks authorized for
medical assistants, especially given the unique setting, virtual
automation of the subject test and the array of supervisory,
licensed health care personnel in the plasma collection center -
including the responsible physician and surgeon and/or other
licensed 'facility' manager. The end goal of this measure is to
help licensed plasma donation centers operate more efficiently
by authorizing a medical assistant to conduct this simple task
as part of the donor intake process."
The Blood Centers of California writes in support, "The need for
source plasmas - defined as the fluid portion of human blood
collected by plasmapheresis and intended as source material for
further manufacturing use is growing. Source plasma is used to
develop plasma based medicines and therapies which are used to
treat over eighty diseases.
Assuring that eligible, trained personnel are available for this
growing segment of the blood industry is necessary. We support
the designation of a "donor center processor' as the staff who
can perform the" simple, automated total protein refractometer".
AB 757 will assure that licensed plasma centers have the
appropriate staff carrying out the necessary functions to obtain
and process source plasma which is converted into life
sustaining medicines and therapies."
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ARGUMENTS IN OPPOSITION:
The California Association for Medical Laboratory Technology
writes in opposition, "The primary function of the total protein
analysis is to provide an accurate and precise value in order to
ensure donor safety prior to donating plasma. An erroneously
performed analysis, like a false negative result, which allows
the plasma center to proceed with the donation, could cause
significant donor harm. As a result, the regulatory agencies
have mandated that the individuals performing the total protein
test must have demonstrated a higher level of education and
training such as those individuals listed in BPC section 1206.5
(b).
Plasma donors are paid. They can donate every two weeks if their
total protein is at least 6 g/dL. Many plasma collection
centers "bleed" their donors down to 6 g/dL of protein
regularly. If the protein refractometer test and/or calibration
is done incorrectly and the protein read is higher than it
actually is, there is a potential to over "bleed" a donor
causing donor harm, such as death from untreated low protein,
immune deficiency, heart and respiratory problems, bruising,
insufficient blood clotting, muscle wasting and reduced energy.
In short, the current personnel standard needs to be
maintained."
The California Society of Pathologists writes in opposition, "We
believe that this type of legislation that would seek to carve
out certain tests from the CLIA and state personnel requirements
will only lessen the quality of testing? There are existing
laboratory personnel who can perform this test. We believe
maintaining that standard is preferable to undoing the existing
test classification system that is universal to clinical
laboratory practice. That system is designed to maintain test
result integrity and protection for patients."
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The Engineers & Scientists of California, IFPTE Local 20 , writes
in opposition, "ESC, which represents Clinical Laboratory
Scientists, strongly believes that having unlicensed, untrained
individuals performing these tests, even if its moderate to low
complexity, isn't good for patient safety. It's going backwards
to a time before phlebotomy certification."
POLICY ISSUES FOR CONSIDERATION:
This bill seeks to carve out a narrow personnel exception for a
specific device that performs a moderately complex test on human
blood. According to the sponsors, the device is used in the
very initial screening process, and even if there was an error
in the testing, the rest of the intake process will properly
screen the individual.
However, there are other waived devices that the sponsor can use
without having to make a special exception in law. The sponsor
has stated that it is in process switching to a waived device.
AMENDMENTS:
18)Insert a three year sunset provision to provide the sponsor
an opportunity to finish switching to a waived device.
On page 2, between lines 26-27, insert subdivision (b):
(b) This section shall remain in effect only until January 1,
2019, and as of that date is repealed.
19)Narrow the class of test to ensure that only the device the
sponsor wants excluded is included in the bill:
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On page 2, between lines 12-13, insert:
(2) He or she performs the total protein refractometer test
analysis using an automatic, button-operated refractometer
with a digital readout.
20)Make conforming changes:
On page 2, line 7, before "A" insert subdivision (a):
(a)
On page 2, line 11, strike out "(a)" and insert:
(1)
On page 2, line 13, strike out "(b)" and insert:
(3)
On page 2, line 15, strike out "(c)" and insert:
(4)
On page 2, line 20, strike out "(d)" and insert:
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(5)
On page 2, line 23, strike out "e" and insert:
(6)
REGISTERED SUPPORT:
Grifols, Inc. (sponsor)
Blood Centers of California
REGISTERED OPPOSITION:
California Association for Medical Laboratory Technology
California Society of Pathologists
Engineers & Scientists of California, IFPTE Local 20
Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301
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