BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K Alquist, Chair
BILL NO: AB 221
A
AUTHOR: Portantino
B
AMENDED: June 11, 2009
HEARING DATE: July 8, 2009
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CONSULTANT:
2
Orr/
1
SUBJECT
HIV testing: skin punctures
SUMMARY
Permits HIV counselors to perform basic skin punctures for
the purpose of administering rapid HIV tests. Requires HIV
counselor training program curriculum to include rapid HIV
test proficiency and universal infection control
precautions.
CHANGES TO EXISTING LAW
Existing law:
Authorizes the establishment of training programs for
counselors of publicly funded human immunodeficiency virus
(HIV) testing programs at community-based nonprofit
organizations, with the stipulation that the programs
follow curriculum content and design approved by the
department. Stipulates that counselors trained in these
programs be subject to existing state and local testing and
successful completion of the program.
Requires that costs associated with these training programs
be absorbed by the organizations.
Authorizes those HIV counselors who are trained by the
Office of AIDS and working in an HIV counseling and testing
Continued---
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site funded by the department, 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.
Allows those who have successfully completed HIV counselor
training to substitute this training for the High School
Diploma or GED requirement needed in order to advance to
the limited phlebotomy technician training.
Provides that the law does not require nor prohibit the
department or any local entity from funding community-based
training programs, nor does it restrict community-based
organizations from participating in existing local training
programs.
Permits the department 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 the results from
this confirmatory test differ from the results of the rapid
test.
This bill:
Adds training in both skin puncture and oral swab rapid HIV
tests, and universal infection precautions consistent with
best practices established by the Division of Occupational
Safety and Health in the Department of Industrial Relations
and the CDC to the existing HIV counselor training
curriculum.
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 certified and trained in
infection control precautions. HIV counselors that were
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certified prior to the inclusion of infection control
curriculum are given two years from the date the department
approves the training to fulfill that requirement.
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.
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.
Deletes the authorization for the department to participate
in a rapid HIV test research program conducted with the
CDC.
States findings regarding the prevalence of HIV in
California, and the need for greater access to HIV testing.
Adds an urgency clause, to take effect immediately, based
on the necessity to contain the AIDS epidemic.
FISCAL IMPACT
The Assembly Appropriations Committee estimates no direct
fiscal impact to authorize counselors to conduct rapid HIV
testing via skin punctures. Minor savings are estimated to
the extent that rapid skin tests become less
administratively burdensome and less costly. Minor savings
are also estimated in testing costs to the extent this bill
results in a shift from a more expensive oral swab test
($12) to a less expensive skin puncture test ($7). The
Appropriations Committee notes that due to recent budget
cuts, the statewide budget for HIV testing has been reduced
from $10.4 million to $9.8 million.
BACKGROUND AND DISCUSSION
The author states that training for Limited Phlebotomy
Technicians (LPTs) is excessive, more costly and less
practical than HIV counselor training, for the purpose of
testing individuals for their HIV status. The author
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believes the counselors only need to be instructed on
necessary precautions regarding what is necessary to
properly administer a fingerstick rapid HIV test, and not
the entire breadth of phlebotomy training. The author
believes the counselors need knowledge of universal
precautions for infection control, and would like this
training to be wholly included in HIV counselor training.
The author also contends that, without this bill, the state
will not be in a position to take advantage of new rapid
confirmity test protocol.
Phlebotomist training
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
terminology pertaining to the circulatory system, specimen
collection, risk factors and complications and quality
assurance in specimen collection.
Laboratory testing requirements
According to the CDC, an estimated 7-10 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 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
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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 the federal
Clinical Laboratory Improvement Amendments program of 1988
(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.
Rapid HIV tests
Rapid tests can play an important role in HIV prevention
activities and expand access to testing in both clinical
and nonclinical settings. A rapid HIV test uses blood from
a vein or a finger stick, or oral fluid, and tests for the
presence of HIV antibodies. It produces results in as soon
as 20 minutes, and those results are interpreted visually,
requiring no additional devices or instrumentation. The FDA
has approved four rapid HIV tests for use in the United
States at point-of-care sites outside of a laboratory. All
of the tests require periodic use of quality controls to
verify the accuracy of the testing kits, and persons
undergoing testing are required by the FDA to be given an
information sheet, specifying that rapid test results need
to be confirmed with additional testing.
Rapid tests provided at the point-of-care can make HIV
testing accessible in locations with limited laboratory
facilities and greatly reduce the number of persons who do
not learn their test results. Point-of-care testing can
also provide immediate test results that are needed to make
decisions about antiretroviral preventive treatment for
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pregnant women in labor, and for health care workers who
have had occupational exposures to blood or body fluids.
Since results obtained using the rapid HIV test may be
provided on the day of the test, this expedites knowledge
of one's HIV status and reduces the field effort needed to
locate and counsel those people who turn out to be HIV
positive. Research has shown that knowledge of HIV-positive
status, combined with counseling, can facilitate behavior
change in infected individuals, allowing for partner
notification and other preventive efforts.
New HIV rapid test protocol
The CDC is expected to release new protocol within the next
year, likely allowing test sites to provide an immediate
rapid confirmatory test. The CDC is likely to recommend
that the second confirmatory test be a blood test. This
means that there could be an increased need for HIV
counselors able to perform the fingerstick tests.
Related legislation
AB 1045 (John A. Perez) permits clinical laboratories to
report to the local health officer only those CD4+T-Cell
test results known to be related to a case of HIV
infection. Currently in Senate Appropriations Committee.
Prior legislation
(Leno) Chapter 2, Statutes of 2004, provided that an HIV
counselor acting in accordance with specified provisions,
and who successfully completes the HIV counselor training,
shall be deemed to have demonstrated sufficient literacy
and comprehension to advance to the limited phlebotomy
technician (LPT) training and to substitute completion of
the HIV counselor training for the requirement for a high
school diploma or General Education Development (GED)
equivalent for a limited phlebotomy technician, and would
revise the conditions under which an HIV counselor may
perform these HIV tests. The bill also declared that it is
the intent of the Legislature that the Office of AIDS, in
consultation with the Laboratory Science Division of the
department, develop a comprehensive curriculum that
integrates appropriate training for an HIV counselor and an
LPT that meets the LPT training standards set forth in
designated statutes and regulations.
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AB 2064 (Cedillo) Chapter 273, Statutes of 2002, requires
the State Department of Health Services to authorize the
establishment of training programs for counselors for
publicly funded HIV testing programs, by specified
community-based, nonprofit organizations. The bill would
require the participating community-based organizations to
follow curriculum content and design for these training
programs that is approved by the department.
AB 1263 (Migden) Chapter 324, Statutes of 2001, authorized
the State Department of Health Services to participate in a
rapid immunodeficiency virus test research program
conducted with the federal Centers for Disease Control and
Prevention. The bill additionally authorized the department
to implement a rapid HIV test program in testing sites
designated by the department, using specified tests, and in
accordance with specified criteria.
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 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 (CAMLT) expressed concern regarding training in
infection control principles, and takes the position of
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oppose unless amended. They suggest the bill be amended to
require the department to establish training requirements
for HIV counselors defining the minimum amount of 10 hours
of didactic training and 15 successful finger sticks for
certification as an HIV counselor. CAMLT believes the
training should also include preparation of the patient,
risk factors and complications, post puncture care, and
biohazardous waste disposal.
PRIOR ACTIONS
Assembly Floor: 74-0
Assembly Appropriations: 16-0
Assembly Health: 17-0
Assembly Business and Professions: 10-1
POSITIONS
Support: AIDS Healthcare Foundation
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.
San Francisco AIDS Foundation
Oppose: California Association for Medical Laboratory
Technology (unless amended)
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