BILL ANALYSIS
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|Hearing Date:July 7, 2003 |Bill No:AB |
| |1087 |
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SENATE COMMITTEE ON BUSINESS AND PROFESSIONS
Senator Liz Figueroa, Chair
Bill No: AB 1087Author:Frommer
As Amended:April 30, 2003 Fiscal:No
SUBJECT: Venipuncture.
SUMMARY: Allows a "certified phlebotomy technician" to
perform venipuncture or skin puncture to obtain a specimen
for nondiagnostic tests, as specified, provided the
technician is under the general supervision of a specified
licensed health personnel.
Existing law:
1)Provides for the licensing and regulation of clinical
laboratories and various clinical health personnel by the
Department of Health Services (DHS), and regulates the
conditions under which laboratory tests are to be
performed and the type of personnel who may perform them
based on the type and complexity of the test as
classified by the federal Clinical Laboratory Improvement
Act of 1988 (CLIA).
2)Provides that an unlicensed person employed by a licensed
clinical laboratory, may perform venipuncture or skin
puncture for the purpose of withdrawing blood or for
clinical lab test purposes if he or she:
a) Receives authorization from a licensed physician.
b) Works under the supervision of a person who is no
more than 5 minutes away and who is a licensed
physician, a registered nurse, or licensed under the
clinical lab law.
c) Has successfully completed training by a licensed
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physician or clinical lab bioanalyst in the proper
procedure to be used when withdrawing blood in
accordance with training requirements established by
DHS; and
d) Is certified as a "certified phlebotomy technician"
pursuant to regulations adopted by the DHS.
1)Requires the DHS to adopt the certification regulations
for phlebotomy technicians by January 1, 2001 (final
regulations were finally adopted on April 9, 2003) and
requires those regulations to require applicants for
certification to:
a) Hold a current certification as a phlebotomist
issued by a national accreditation agency approved by
DHS.
b) Complete education, training and experience that
include at least certain amounts of didactic and
practical instruction and at least 50 successful
venipunctures or, in the alternative, have at least
1,040 hours of specified work experience.
1)Requires certified phlebotomy technicians to: complete at
least three hours per year or six hours every two years
of continuing education or training, be found competent
in phlebotomy by a licensed physician or person licensed
under the clinical lab law, and work under the
supervision of a licensed physician, registered nurse, or
a person licensed under the clinical lab law.
This bill:
1)Authorizes a certified phlebotomy technician to perform
venipuncture or skin puncture to obtain a specimen for
nondiagnostic tests assessing the health of an
individual, provided the technician works under the
general supervision of a licensed physician, a registered
nurse, or a person licensed under the clinical lab law.
2)Defines "general supervision" as requiring that a
supervisor:
a) Review the competency of the technician to perform
venipuncture or skin puncture prior to the
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technician's first blood withdrawal, and on an annual
basis thereafter.
b) Review the work of a technician on a monthly basis
to ensure compliance with appropriate venipuncture or
skin puncture policies, procedures and regulations.
1)Requires the supervisor or another designated licensed
physician, registered nurse or person licensed under the
clinical lab law to be available for consultation with
the technician, either in person or through electronic
means, at the time of the blood withdrawal.
FISCAL EFFECT: Legislative Counsel has determined that
this is a non-fiscal measure.
COMMENTS:
1.Purpose. This bill is intended to clarify that
phlebotomists may obtain blood specimens for
nondiagnostic tests assessing the health of an individual
in non-clinical laboratory settings, provided the
phlebotomists meet all of the professional standards and
requirements, including certification pursuant to
regulations adopted by the DHS, and work under the
general supervision of a licensed physician, registered
nurse or a person licensed under the clinical lab law.
2.Background. According to the author, a coalition of
paramedical companies that provide phlebotomy services
for the insurance underwriting industry have organized to
bring this issue to the Legislature. They state that the
paramedical industry performs, without incident,
approximately one million blood draws annually in
California for the sole purpose of gathering information
to make underwriting determinations for life, health or
disability insurance. These blood draws are not
performed as part of patient care.
AB 1557 (Migden, Chapter 695, Statutes of 1999) was enacted
in response to an incident in which a lab technician was
found to have reused needles to draw blood from different
patients. AB 1557 was intended to improve the
certification and training standards for phlebotomists,
and did so by amending state clinical lab law where the
regulation of phlebotomists is provided.
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The author and proponents state that the DHS interprets the
current law as not only increasing the standards for
phlebotomists, but also requiring the paramedical
companies employing them to obtain licensure as a
clinical laboratory. This is the case even though they
simply serve as the intermediary between the insurer and
the laboratory where the specimen is taken, and do not
perform any diagnostic evaluations or interpret findings
for treatment of diagnostic purposes.
In 2002, proponents state that the DHS began to enforce the
provisions of the law against paramedical companies
performing phlebotomy for insurance underwriting
purposes, but not diagnosis or treatment. The proponents
argue that this enforcement threatens to close operations
of paramedical organizations, even though the law is not
clear and does not directly address venipuncture
performed for non-treatment or nondiagnostic purposes.
3.Arguments in Support. Proponents state that this bill
represents a reasonable compromise by allowing these
firms to continue to perform phlebotomy services for
limited purposes without clinical lab licensure, while
ensuring that the phlebotomists meet all the safety and
training standards, including the new certification
requirements just adopted by the DHS in its phlebotomist
regulations.
Proponents argue that life insurers have used the services
of phlebotomists for years to obtain blood samples and
have found them to be a convenient alternative with an
impeccable safety record. They argue that the
paramedical companies that employ the phlebotomists
simply serve as intermediaries between the insurer and
the laboratory that actually performs the lab tests.
4.Related legislation. AB 371 (La Suer) is another bill
this year dealing with phlebotomists. AB 371 would allow
a certified phlebotomy technician to withdraw blood in
specified locations outside a clinical lab with general
supervision as defined. AB 371 was passed by this
committee, then the Senate Public Safety committee, and
is now pending in the Senate Judiciary Committee.
SUPPORT AND OPPOSITION:
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Support :Association of California & Health Insurance
Companies (ACLHIC)
Health Insurance Association of America (HIAA)
American Para Professional Systems, Inc.
ExamOne World Wide, Inc. and LabOne, Inc.
Hooper Holmes, Inc.
Examination Management Services, Inc.
Clinical Reference Laboratory, Inc.
Opposition :None received by July 2, 2003.
Consultant:Jay J. DeFuria