BILL ANALYSIS Ó
AB 1215
Page 1
ASSEMBLY THIRD READING
AB 1215 (Hagman and Holden)
As Amended April 9, 2013
Majority vote
BUSINESS & PROFESSIONS 13-0 HEALTH
19-0
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|Ayes:|Gordon, Jones, Bocanegra, |Ayes:|Pan, Logue, Ammiano, |
| |Campos, | |Atkins, |
| |Dickinson, Eggman, | |Bonilla, Bonta, Chesbro, |
| |Hagman, | |Gomez, |
| |Holden, Maienschein, | |Roger Hernández, |
| |Mullin, | |Lowenthal, |
| |Skinner, Ting, Wilk | |Maienschein, Mansoor, |
| | | |Mitchell, |
| | | |Nazarian, Nestande, V. |
| | | |Manuel Pérez, |
| | | |Wagner, Wieckowski, Wilk |
|-----+--------------------------+-----+--------------------------|
| | | | |
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SUMMARY : Redefines the term "laboratory director" to allow a
licensed clinical laboratory scientist (CLS) to operate as the
director of a clinical laboratory when performing simple tests
exempted from the federal Clinical Laboratory Improvements
Amendments (CLIA) of 1988.
FISCAL EFFECT : None. This bill is keyed non-fiscal by the
Legislative Counsel.
COMMENTS : This bill would allow CLSs to operate as laboratory
directors overseeing clinical laboratories performing less
complex CLIA-waived tests, thereby expanding the pool of
individuals qualified to fill such positions. As federal law
already authorizes CLSs to become laboratory directors but
California does not, this bill would conform state law to
federal law.
California clinical laboratories are subject to both federal and
state oversight. The federal CLIA regulates clinical
laboratories based on the complexity (low, moderate or high) of
the tests offered. In conformity with CLIA, California
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Department of Public Health licenses or registers clinical
laboratories according to the complexity of the tests they
perform. Laboratories must be licensed for moderately or highly
complex procedures, and registered for low complexity. About
3,000 clinical laboratories are licensed for moderate and/or
high complexity testing. The remaining are registered
laboratories performing waived tests and/or provider-performed
microscopy.
This bill deals specifically with tests that are 'waived', or
exempt from regulatory oversight, because they are approved by
the Food and Drug Administration for home use, utilize simple
and accurate methods that make the possibility of error
negligible, or pose no significant risk of harm to the patient
if incorrectly performed. Any person can purchase these tests
from pharmacies, drugstores, supermarkets, or retail stores and
conveniently perform the test at home. Examples of these tests
include: dipstick or tablet reagent urinalysis, stool sampling,
ovulation tests, urine pregnancy tests, and certain tests of a
small amount of blood obtained by skin prick or blood draw.
A laboratory director must be a licensed physician and surgeon
or meet other licensure requirements, and is responsible for
overseeing the overall operation and administration of the
laboratory. Under federal CLIA, CLSs can be waived laboratory
directors. Under state law, for the purposes of waived tests, a
laboratory director can also include a licensed naturopathic
doctor, an optometrist or a person licensed to direct a clinical
laboratory and who substantially meets the laboratory director
qualifications under CLIA for the type and complexity of tests
being offered by the laboratory. In recent years, state
legislation has expanded the definition of who can become a
laboratory director for waived laboratory tests (naturopaths,
optometrists, and pharmacists), and this bill would add a CLS to
that list.
A laboratory director of a clinical laboratory performing waived
tests is responsible for the overall operation and
administration of the waived laboratory, including: ensuring
that testing personnel are competent to perform test procedures;
recording and reporting test results promptly, accurately, and
proficiently; and assuring compliance with the applicable
regulations relating to the state laboratory law and the federal
CLIA. While the laboratory director may delegate such duties to
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persons who meet appropriate qualifications, the laboratory
director is responsible for ensuring that all assigned duties
and testing are properly performed. The laboratory director
would also be accessible to the laboratory to provide onsite,
telephone, or electronic consultation as needed.
By including CLSs in the definition of a "laboratory director,"
this bill would effectively allow CLSs to independently perform
waived tests without supervision by another laboratory director.
This would also allow a CLS who wishes to work part-time to
operate a clinical laboratory performing CLIA-waived tests.
CLSs are already licensed to perform the highest category of
tests and are specifically trained in laboratory science and can
ensure that tests are being performed properly and specimen
procurement and handling are in accordance with protocols.
Therefore, CLSs are presumably capable of performing the duties
of a waived laboratory director, and may allow healthcare
providers to hire CLSs more affordably than a physician or
surgeon.
Analysis Prepared by : Joanna Gin / B., P. & C.P. / (916)
319-3301
FN: 0000323