BILL ANALYSIS
AB 221
Page 1
Date of Hearing: April 21, 2009
ASSEMBLY COMMITTEE ON HEALTH
Dave Jones, Chair
AB 221 (Portantino) - As Introduced: February 4, 2009
SUBJECT : HIV testing: skin punctures.
SUMMARY : Permits a human immunodeficiency virus (HIV)
counselor to perform skin punctures for the purpose of HIV
testing, under specified conditions. Specifically, this bill :
1)Exempts an HIV counselor from the requirement that an
unlicensed person performing skin punctures must be a
certified phlebotomy technician.
2)Permits an HIV counselor to perform skin punctures for
withdrawing blood for HIV testing, upon specific authorization
from a licensed physician, if both of the following apply:
a) He or she works under the direction of a licensed
physician; and,
b) He or she has been trained in accordance with
requirements established by the Department of Public Health
(DPH), by a licensed physician or a licensed clinical
laboratory scientist or bioanalyst, in the procedures to be
employed when conducting the skin puncture.
EXISTING LAW :
1)Authorizes DPH to participate with the federal Centers for
Disease Control and Prevention (CDC) in a rapid HIV test
research program, and authorizes an HIV counselor who is
trained by the DPH Office of AIDS (OA) and working in a
DPH-funded HIV testing and counseling site to perform skin
punctures if he or she meets prescribed requirements.
2)Allows an unlicensed person employed by a clinical laboratory
to perform venipuncture or skin puncture for the purpose of
withdrawing blood or for clinical laboratory test purposes
provided he or she is supervised by a licensed clinical
laboratory scientist, physician, or registered nurse and has
been trained by a licensed physician or licensed clinical
laboratory bioanalyst, as specified, and has a current
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certification as a certified phlebotomy technician.
3)Requires DPH to authorize the establishment of training
programs throughout the state for counselors for publicly
funded HIV testing programs. Requires the training programs
to be conducted by community-based, nonprofit organizations
with expertise in providing free, anonymous, or confidential
HIV testing services, and to follow a curriculum approved by
DPH.
EXISTING REGULATIONS :
1)Establish the class of limited phlebotomy technician (LPT),
and require an LPT to be a high school graduate or equivalent,
complete 20 hours of basic didactic instruction from a
DPH-approved program, and complete at least 25 skin punctures,
as specified, for certification.
2)Establish standard practices relating to occupational exposure
to bloodborne pathogens, including a requirement for
needleless systems or sharps with engineered sharps injury
protection and training on infection prevention.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill is
needed to remove a barrier to rapid HIV screening. The author
states that because of its simplicity, safety, and ease of
use, skin puncture or finger stick technology requires very
little training. However, in order to perform a finger stick,
California law requires a person to be certified as an LPT,
which requires a person to receive 20 hours of didactic
training and complete 25 skin punctures in a clinical setting.
The author argues the only training that is actually
necessary in a finger stick rapid HIV testing protocol is
knowledge of universal precautions for infection control,
which can be accomplished in two hours of the LPT training.
The author contends that the remainder of the didactic
training consists of topics that are irrelevant to the task of
administering the rapid HIV test. According to the author,
the training costs over $2,500 per counselor, including
classes, practical experience, and lost productivity. The
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author states that since the LPT requirement was adopted, HIV
test sites have spent over $1 million certifying LPTs, which
is significant in light of the decrease in state funds
available for testing, from $10.4 million to $9.8 million in
the current year. The author argues the number of certified
LPTs is limited by the training costs.
According to materials provided by the author, allowing HIV
counselors to administer a finger stick HIV test would result
in considerable cost savings. The finger stick test kit costs
$4 less than the oral swab test, which results in a savings to
the AIDS Healthcare Foundation (AHF) of $160,000 per year.
However, the author states it would cost $112,500 to certify
the 45 staff HIV counselors to administer the tests as LPTs,
as required in current law, eliminating 70% of the potential
savings from using the finger stick tests. Moreover, the
author argues that the California Occupational Health
Administration requires the use of needleless systems and
sharps devices with engineered injury protection. The author
notes that millions of Californians with diabetes use safety
lancets to self-administer a finger stick to monitor their
blood glucose everyday. The author states that LPT training
is conducted by private institutions and is not required to
adhere to a known curriculum. HIV counselor training must be
approved by DPH and has clear standards, including infection
control.
2)BACKGROUND . In November 2008, OA estimated that there are
between 132,000 and 170,000 persons living with HIV or AIDS in
California and an additional 27,369 to 33,513 persons who are
infected with HIV but not aware, and therefore not receiving
any primary HIV-related medical care. OA estimates between
5,000 and 7,000 Californians become infected with HIV each
year.
3)HIV TESTING . According to the CDC, people who are infected
with HIV but are not aware of it are not able to take
advantage of therapies that can keep them healthy and extend
their lives, nor do they have the knowledge to protect their
sex or drug-use partners from becoming infected. Studies have
demonstrated that many infected persons decrease behaviors
that transmit infection to sex or needle-sharing partners once
they are aware of their positive HIV status. People who do
not know they are infected with HIV do not reduce risk
behaviors. Because medical treatment that lowers HIV viral
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load might also reduce risk for transmission to others, early
referral to medical care could decrease HIV transmission in
communities while reducing a person's risk for HIV-related
illness and death.
The CDC stresses the important role of rapid HIV screening tests
as a measure to facilitate early diagnosis in high prevalence
areas and for high-risk individuals. Rapid HIV tests can be
completed while a person waits, within 20 to 40 minutes. With
rapid HIV testing, a positive test result is considered a
preliminary positive, and requires a confirmatory test because
a small percentage of the positive test results will not be
correct. Confirmatory tests use different methods to confirm
a diagnosis of HIV infection. DPH writes that with rapid HIV
testing, counselors are able to engage clients in a single
session and virtually everyone who gets a rapid HIV test
receives their preliminary results. Prior to rapid testing,
DPH states one-quarter to one-third of clients did not return
for their test results. The CDC states that persons tested
for HIV who do not return for test results might have an
increased risk of transmitting HIV to partners. As of June
2008, about 50% of DPH's HIV testing was conducted by rapid
HIV testing. DPH has a goal of providing 85% rapid tests
statewide.
4)HIV COUNSELOR TRAINING . According to the San Francisco
Department of Public Health Web site, HIV counselor training
requires four days of basic training, a two-day advanced
training three months later, and one day of continuing
training each year.
5)SUPPORT . AHF, co-sponsor of this bill, writes in support that
the most essential tool for expanding access to HIV screening
is the HIV rapid test, which can be administered either
through a finger stick or an oral swab. AHF states the oral
swab kit costs more than twice as much as the finger stick
kit. AHF contends the cost of LPT training has discouraged
test sites from increasing the number of HIV counselors who
are LPTs and that the most important part of training for
someone who administers HIV rapid tests, infection control, is
provided during the HIV counselor training, not the LPT
training. AHF contends nearly all of the 20 LPT training
hours are spent practicing finger sticks on dummies and other
students while using a retractable safety lancet that requires
little to no instruction. Finally, AHF argues that within the
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next year, test sites will be able to provide immediate
confirmatory tests, but this test will be a finger-stick test,
not an oral swab test. AHF argues that without this bill,
access to the rapid confirmatory HIV test will be curtailed.
The San Francisco AIDS Foundation (SFAF), another co-sponsor
of this bill, and Planned Parenthood Affiliates of California,
Inc. (PPAC) write this bill will expand access to HIV rapid
screening by allowing HIV test sites to take advantage of the
significantly lower cost of the HIV finger stick test. SFAF
and PPAC state the only training that is really needed for a
finger stick rapid HIV test is knowledge of universal
precautions for infection control, which is already included
in the extensive training required to become an HIV counselor.
The California Medical Association writes in support this
bill will eliminate barriers to HIV rapid screening by
reforming training standards for HIV counselors who only
administer the finger stick tests under appropriate physician
oversight. American Federation of State, County, and
Municipal Employees, AFL-CIO states it supports the intent of
this bill to ensure access to HIV testing. The California
Primary Care Association states this bill will eliminate some
of community clinics and health centers' barriers to providing
HIV rapid testing.
6)OPPOSITION . The California Nurses Association/ National
Nurses Organizing Committee (CNA) states in opposition to this
bill that regardless of the device used for the skin puncture,
blood must be dripped for testing. According to CNA, health
care personnel who become infected with hepatitis B virus
(HBV) often cannot recall a needle stick. CNA states HBV
survives in dried blood on environmental surfaces for at least
one week and can be transmitted from a surface through
chapped, broken skin or cuts on the hand, not just through an
accidental needle stick. CNA argues an oral test is less
dangerous to the tester, and notes it is an option for people
who do not like needle sticks or are otherwise afraid of a
blood test. Finally, CNA argues this bill erodes the minimal
protections and certification that assure protection from
blood borne diseases, and the 20 hours of training and 25 skin
punctures are a small price to pay to assure safety and
accuracy in testing.
7)RELATED LEGISLATION . AB 1045 (John A. Perez), pending in the
Assembly, permits clinical laboratories to report to the local
health officer only CD4+ T-cell test results known to be
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related to a case of HIV infection.
8)PREVIOUS LEGISLATION .
a) AB 685 (Leno) Chapter 2, Statutes of 2004, exempts HIV
counselors from the Department of Health Services (now DPH)
regulations that require training and certification for
phlebotomy technicians.
b) AB 2064 (Cedillo) Chapter 273, Statutes of 2002 requires
DHS (now DPH) to authorize the establishment of training
programs for counselors for publicly funded HIV testing
programs. Requires that training programs be conducted by
organizations with demonstrated expertise in providing
free, anonymous or confidential HIV testing.
9)POLICY QUESTION . Although this bill requires an HIV counselor
conducting rapid HIV testing to be trained in the procedures
for conducting the test, the author may wish to address the
extent to which the current HIV counselor training covers
infection control measures.
10)SECOND COMMITTEE OF REFERENCE . This bill was heard in
Assembly Business and Professions Committee on March 31, 2009,
and was approved on a 10-1 vote.
REGISTERED SUPPORT / OPPOSITION :
Support
AIDS Healthcare Foundation (sponsor)
San Francisco AIDS Foundation (sponsor)
American Federation of State, County, and Municipal Employees,
AFL-CIO
California Communities United Institute
California Medical Association
California Primary Care Association
City and County of San Francisco
Planned Parenthood Affiliates of California, Inc.
Opposition
California Nurses Association/ National Nurses Organizing
Committee
Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097