BILL ANALYSIS
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|SENATE RULES COMMITTEE | AB 221|
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THIRD READING
Bill No: AB 221
Author: Portantino (D), et al
Amended: 8/17/09 in Senate
Vote: 27 - Urgency
SENATE HEALTH COMMITTEE : 10-1, 7/8/09
AYES: Alquist, Strickland, Aanestad, Cedillo, DeSaulnier,
Leno, Maldonado, Negrete McLeod, Pavley, Wolk
NOES: Cox
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
ASSEMBLY FLOOR : 74-0, 5/14/09 - See last page for vote
SUBJECT : HIV testing: skin punctures
SOURCE : AIDS Healthcare Foundation
San Francisco AIDS Foundation
DIGEST : This bill permits HIV (human immunodeficiency
virus) counselors to perform basic skin punctures for the
purpose of administering rapid HIV tests.
ANALYSIS :
Existing law:
1. Authorizes the establishment of training programs for
counselors of publicly funded HIV testing programs at
community-based nonprofit organizations, with the
CONTINUED
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stipulation that the programs follow curriculum content
and design approved by the Department of Public Health
(DPH).
2. Stipulates that counselors trained in these programs be
subject to existing state and local testing and
successful completion of the program.
3. Requires that costs associated with these training
programs be absorbed by the organizations.
4. Authorizes those HIV counselors who are trained by the
Office of AIDS and working in an HIV counseling and
testing site funded by DPH, to perform any HIV test
classified as waived under the federal Clinical
Laboratory Improvement Amendments of 1988 (CLIA), if the
person performing the test meets certain requirements.
Nothing in statute shall be construed to allow an HIV
counselor trained by the Office of AIDS to perform any
HIV test that is not classified as waived under CLIA.
5. Allows those who have successfully completed HIV
counselor training to substitute this training for the
high school diploma or general equivalency diploma
requirement needed in order to advance to the limited
phlebotomy technician training.
6. Provides that the law does not require nor prohibit DPH
or any local entity from funding community-based
training programs, nor does it restrict community-based
organizations from participating in existing local
training programs.
7. Permits DPH to participate in an HIV test research
program conducted with the federal Centers for Disease
Control and Prevention (CDC) that utilizes a rapid HIV
test for diagnosis, prior to approval from the federal
Food and Drug Administration (FDA). Test performance
and reporting of the results are only to be done to the
extent allowed by the tests' investigational approval by
the FDA and according to the California Health and Human
Services Agency Institutional Review board-approved
research protocol. A second independent test to confirm
results is required. The subject is to be notified if
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the results from this confirmatory test differ from the
results of the rapid test.
This bill:
1. Authorizes an HIV counselor to perform skin punctures
for the purpose of withdrawing blood for HIV testing
upon specific authorization from a licensed physician or
surgeon provided the counselor has been trained in both
HIV test proficiency for skin puncture blood tests and
oral swab tests and in universal infection control
precautions.
2. Stipulates that HIV counselors may not perform skin
punctures without completing training on the new
curriculum, unless the counselor is already certified as
an LPT.
3. Specifies that this statute shall not be construed to
certify an HIV counselor as a phlebotomy technician
unless the counselor has otherwise satisfied the proper
certification requirements.
4. Deletes the authorization for DPH to participate in a
rapid HIV test research program conducted with the CDC.
5. States findings regarding the prevalence of HIV in
California, and the need for greater access to HIV
testing.
6. Adds an urgency clause, to take effect immediately,
based on the necessity to contain the AIDS epidemic.
Comments
According to the CDC, an estimated seven to 10 billion
laboratory tests are performed each year in the United
States, and laboratory test results influence approximately
70 percent of all medical decisions. Increasingly, these
decisions are based on simple tests performed at the
point-of-care, using devices that are waived from most
federal oversight requirements, including requirements for
personnel qualifications and training, quality control
(unless specified as required in the test system
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instructions), proficiency testing, and routine quality
assessment.
Advances in technology have made tests simpler,
contributing to this shift in testing. Many tests can now
be performed using compact or hand held devices by
personnel with limited experience and training. These
advances have enabled more testing to be performed in
emergency departments, hospital rooms, and physicians'
offices and in nontraditional testing sites such as
community counseling centers, nursing homes, and health
fairs. Some tests can now even be self-administered, such
as blood glucose testing for diabetes patients, which
require use of the same type of retractable safety lancet
as the rapid HIV fingerstick test.
All laboratory testing is regulated under CLIA,
administered under the Centers for Medicare and Medicaid
Services, which classifies tests according to their
complexity. To receive a CLIA waiver, tests must use
direct, unprocessed specimens (such as whole blood or oral
fluid) and be easy to perform with a negligible chance of
error. Waived tests can be performed by persons without
formal laboratory training outside traditional
laboratories. Waived tests, suitable for use at the
point-of-care, make it easier for nonclinical testing sites
to offer rapid HIV tests.
Background
Phlebotomy is the act of drawing blood either for testing
or transfusion. Phlebotomists collect blood primarily by
performing venipuncture (puncture of the vein) and, for
collection of minute quantities of blood, fingersticks.
Limited phlebotomy techs are only authorized to perform
skin punctures, whereas, certified phlebotomists can also
perform venipuncture and arterial puncture. Training
requirements for phlebotomists vary by state, and
California and Louisiana are the only states that require
all persons who are not doctors, nurses or clinical lab
scientists to be licensed in those states in order to draw
blood. California requires LPTs to undergo at least 20
hours of didactic training and perform 25 successful
fingersticks. The training includes theory, anatomy and
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terminology pertaining to the circulatory system, specimen
collection, risk factors and complications and quality
assurance in specimen collection.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 8/19/09)
AIDS Healthcare Foundation (co-source)
San Francisco AIDS Foundation (co-source)
AIDS Project Los Angeles
American Federation of State, County and Municipal
Employees
California Association for Nurse Practitioners
California Communities United Institute
California Medical Association
Center for AIDS Research, Education & Services
City and County of San Francisco
City of Los Angeles
County of Los Angeles
Planned Parenthood Affiliates of California, Inc.
OPPOSITION : (Verified 8/19/09)
California Association for Medical Laboratory Technology
(unless amended)
ARGUMENTS IN SUPPORT : The AIDS Healthcare Foundation
contends that the HIV rapid test is the most essential tool
for expanding access to HIV testing. They claim that
curriculum for LPTs does not provide all of the necessary
information a person needs if their primary purpose for the
training is to administer rapid HIV tests. They believe
that the most crucial information the HIV counselor needs
to know are infection control procedures. The San
Francisco AIDS Foundation states that the fingerstick rapid
test is much less costly than the oral swab test, but the
fingerstick test savings are offset by the cost and burden
of training HIV counselors as LPTs in order to administer
the fingerstick. Since the LPT requirement was first
adopted in 2003, test sites have spent over $1 million
certifying LPTs, which is money that could have otherwise
gone to increasing access to testing. Nonprofits and
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government test sites are forced to choose between more
expensive oral swab test kits, or more expensive training
to use the less expensive fingerstick kits.
ARGUMENTS IN OPPOSITION : The California Association for
Medical Laboratory Technology expressed concern regarding
training in infection control principles, and takes the
position of oppose unless amended. They suggest the bill
be amended to require DPH to establish training
requirements for HIV counselors defining the minimum amount
of 10 hours of didactic training and 15 successful
fingersticks for certification as an HIV counselor. The
Association believes the training should also include
preparation of the patient, risk factors and complications,
post puncture care, and biohazardous waste disposal.
ASSEMBLY FLOOR :
AYES: Adams, Anderson, Arambula, Beall, Bill Berryhill,
Tom Berryhill, Blakeslee, Block, Blumenfield, Brownley,
Buchanan, Caballero, Charles Calderon, Carter, Chesbro,
Conway, Cook, Coto, Davis, De La Torre, De Leon, DeVore,
Duvall, Emmerson, Evans, Feuer, Fletcher, Fong, Fuller,
Furutani, Galgiani, Garrick, Gilmore, Hagman, Hall,
Harkey, Hayashi, Hernandez, Hill, Huber, Huffman,
Jeffries, Jones, Knight, Krekorian, Lieu, Logue, Bonnie
Lowenthal, Ma, Mendoza, Miller, Monning, Nava, Nestande,
Niello, Nielsen, John A. Perez, V. Manuel Perez,
Portantino, Price, Ruskin, Salas, Silva, Skinner,
Solorio, Audra Strickland, Swanson, Torlakson, Torres,
Torrico, Tran, Villines, Yamada, Bass
NO VOTE RECORDED: Ammiano, Eng, Fuentes, Gaines, Saldana,
Smyth
CTW/JJA:mw 8/19/09 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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