BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Elaine K. Alquist, Chair
BILL NO: AB 2786
A
AUTHOR: Committee on Health
B
AMENDED: August 20, 2010
HEARING DATE: August 25, 2010
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CONSULTANT:
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Orr/cjt
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PURSUANT TO S.R. 29.10
SUBJECT
Reportable diseases and conditions
SUMMARY
Allows the California Department of Public Health (CDPH) to
modify the list of communicable diseases and conditions for
which clinical labs must submit specimens to the local
public health laboratory to undergo further testing.
Allows CDPH to modify the list at any time, in consultation
with the California Conference of Local Health Officers
(CCLHO) and the California Association of Public Health
Laboratory Directors (CAPHLD). Authorizes additional
disclosures of public health records relating to human
immunodeficiency virus (HIV) or acquired immune deficiency
syndrome (AIDS) between specified local and state public
health agency staff, health care providers, and HIV
positive individuals who are the subject of the records.
Increases the penalties for negligent, willful or malicious
disclosure of content of any confidential public health
record to a third party, except as otherwise authorized by
law.
CHANGES TO EXISTING LAW
Continued---
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Existing law:
Requires CDPH to establish a list of diseases and
conditions which local health officers are required to
report to CDPH, when identified. The list may include both
communicable and noncommunicable diseases. Allows CDPH to
modify this list in consultation with CCLHO and exempts
this modification from the administrative regulation and
rulemaking requirements under California's Administrative
Procedures Act (APA).
Exempts from civil and criminal penalties any person or
facility that fails to provide notification of a
reportable disease or condition, unless the disease or
condition that is required to be reported has been printed
in the California Code of Regulations (CCR) for at least
six months.
Declares public health records relating to human
immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome (AIDS) as confidential and prohibits their
disclosure, except as otherwise provided by law for public
health purposes or pursuant to a written authorization by
the person who is the subject of the record.
Permits state or local public health agencies to disclose
personally identifying information in public health
records, as described, to other local, state, or federal
public health agencies or to corroborating medical
researchers, when the information is necessary to carry out
the duties of the agency or researcher in the
investigation, control, or surveillance of disease, as
determined by the state or local public health agency.
Prohibits the negligent, willful or malicious disclosure of
the content of any confidential public health record, as
defined, to any third party, except pursuant to a written
authorization, as described or as otherwise authorized by
law, and establishes civil penalties for violations of
these provisions.
Establishes that any person who willfully, negligently, or
maliciously discloses the content of any confidential
public health record to a third party that results in
economic, bodily, or psychological harm to the person whose
STAFF ANALYSIS OF ASSEMBLY BILL 2786 (Committee on Health)
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record was disclosed, is guilty of a misdemeanor,
punishable by imprisonment in the county jail and/or a fine
of up to twenty-five thousand dollars ($25,000).
Existing regulations:
Require health care providers and laboratories to report
cases of specified communicable diseases to the local
health officer where the patient resides. Allow individuals
to also report suspected cases of reportable diseases,
where no health care provider is available. Specify the
method(s) and timeframes by which certain diseases may be
reported.
Require all local health department (LHD) employees and
contractors to sign a HIV/AIDS Confidentiality Agreement
prior to accessing confidential HIV-related public health
records, required to be renewed annually. Stipulates that
information reported pursuant to these regulations is
acquired in confidence and shall not be disclosed by the
LHO or his or her authorized designee except as authorized.
This bill:
Requires CDPH to establish a list of communicable diseases
and conditions for which clinical laboratories shall submit
a culture or a specimen to the local public health
laboratory to undergo further study. Deletes specific
diseases that are enumerated in law as mandatory reportable
diseases.
Permits CDPH to modify the list at any time, after
consultation with the CCLHO and the CAPHLD, without being
subject to regular rulemaking requirements under APA, but
requires that CDPH file the revised list with the Secretary
of State for publication in the California Code of
Regulations.
Exempts physicians, surgeons and clinical labs that fail to
submit cultures or specimens for mandatory diseases from
civil and criminal penalties, unless they had been notified
by CDPH and the requirement had been noticed by CDPH for at
least six months in the CCR.
Authorizes specified disclosures of public health records
relating to human immunodeficiency virus or acquired immune
STAFF ANALYSIS OF ASSEMBLY BILL 2786 (Committee on Health)
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deficiency syndrome between specified local public health
agency staff, health care providers, specified state public
health agency staff, and HIV positive individuals who are
the subject of the records, for the purposes of enhancing
completeness of sexually transmitted disease reporting to
the federal Centers for Disease Control and Prevention
(CDC) and offering and coordinating care and treatment
services to HIV positive persons.
Increases the penalties for negligent, willful or malicious
disclosure of content of any confidential public health
record to a third party, except as otherwise authorized by
law.
Makes specified legislative findings and declarations
regarding the need to enable prompt identification of an
outbreak, send positive specimens to the public health
laboratory for identification, and enable CDPH to include
newly emerging diseases and conditions in a timely manner.
Contains contingent language to avoid chaptering out
provisions contained in AB 2541 (Portantino and Fletcher).
FISCAL IMPACT
The Senate Appropriations Committee estimates up to
$185,000 GF for additional laboratory staff at CDPH for FY
10-11, and up to 370,000 in subsequent fiscal years.
Unknown but potentially significant fiscal impact at the
local level if the laboratories' workloads increased enough
to need to hire additional technicians. This bill could
also result in cost avoidance for CDPH-the department would
no longer incur the cost and time associated with the
promulgation of regulations related to the addition of a
disease for which a local public health laboratory or a
CDPH laboratory would receive a specimen. However, any
potential savings would not fully offset the costs of
providing ongoing laboratory staff.
BACKGROUND AND DISCUSSION
According to the sponsor, the Health Officers Association
of California (HOAC), this bill will allow CDPH and local
public health authorities to respond to a public health
emergency in a timely manner by removing the regulatory
STAFF ANALYSIS OF ASSEMBLY BILL 2786 (Committee on Health)
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requirement to include new diseases and conditions on the
list of reportable diseases and conditions. Under current
law, several dozen diseases are reportable by mandate and a
subset of these requires submission of specimens. While the
mandatory disease listing has changed over time, the
universe of diseases under consideration has remained
fairly stable. According to the sponsor, it could take as
long as one and one-half to two years for CDPH to update
the list of reportable diseases, under existing law.
Whereas, under AB 2786, it could take as little as two
months, thereby providing CDPH greater flexibility in a
public health emergency.
Existing law does not exempt CDPH from complying with APA
requirements when modifying the list of reportable diseases
and conditions for which public health labs are required to
submit specimens. The sponsor notes that there have been
instances in which CDPH has requested clinical laboratories
to submit specimens on a voluntary basis for potentially
severe bacterial diseases such as Shiga-toxin producing E.
coli. The sponsor claims that providing these types of
samples on a voluntary basis does not ensure a large enough
sample size to detect common source outbreaks. This was
apparent during a recent E. coli outbreak, during which
clinical laboratories in California were not performing the
additional tests necessary for identifying clusters of
cases revealing a common source outbreak.
According to the author, the most recent amendments will
allow further disclosure of personally identifying
information contained in HIV/AIDS-related public health
records for the purposes of HIV/AIDS reporting, care and
treatment services and case management. These amendments
will also allow HIV/AIDS, STD, and TB co-infection
reporting, medical care, and treatment. This will help
further CDPH's goals of increased reporting for HIV/AIDS
and increased reporting for HIV/AIDS, STD, and TB
co-infections. This should also help secure a maximum
amount of Ryan White and CDC federal funding for HIV/AIDS,
and improve the quality of patient care through better
coordination of HIV, STD, and TB co-infection care and
treatment.
Communicable disease reporting
The list of nationally notifiable infectious diseases is
STAFF ANALYSIS OF ASSEMBLY BILL 2786 (Committee on Health)
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revised periodically. For example, a disease may be added
to the list as a new pathogen emerges, or a disease may be
deleted as its incidence declines. Public health officials
at state health departments and CDC collaborate in
determining which diseases should be nationally notifiable;
the Conference of State and Territorial Epidemiologists
(CSTE), with input from CDC, makes recommendations annually
for additions and deletions to the list of nationally
notifiable diseases. However, reporting of nationally
notifiable diseases to CDC by the states is voluntary.
Reporting is currently mandated (i.e., by state legislation
or regulation) only at the state level. The list of
diseases that are considered notifiable, therefore, varies
slightly by state. All states generally report the
internationally quarantinable diseases (i.e., cholera,
plague, and yellow fever) in compliance with the World
Health Organization's International Health Regulations.
In California, some diseases only require reporting from
health care providers by electronic transmission, including
facsimile, telephone, or mail within seven calendar days of
identification. Examples of these diseases include
Hepatitis (B, C, and D), Tetanus, and Toxic Shock Syndrome.
Diseases can also be required to be reported within one
working day of identification, including, but not limited
to foodborne diseases, Meningitis, Pertussis (Whooping
Cough), West Nile Virus, and Tuberculosis. More acutely
infectious diseases such as Avian Influenza, Rabies (human
or animal), and exposure to Anthrax all require immediate
reporting by telephone. Two or more cases of foodborne
disease from separate households suspected to have the same
source of illness, are also cause for immediate reporting
by telephone.
Clinical laboratories
Health care providers who know of a case, or suspected
case, of any disease or condition on the CDPH list are
required to report to the local health officer of the
jurisdiction where the patient resides and are required to
send specimens to a clinical laboratory. Clinical
laboratories include all hospital laboratories and
community laboratories that receive tests from health care
providers for analysis. Under regulation, labs are
STAFF ANALYSIS OF ASSEMBLY BILL 2786 (Committee on Health)
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required to report test results on certain diseases
considered to be of "public health importance." The list
of communicable diseases and conditions for which
laboratories in California must submit cultures is
currently established by regulation and adding or deleting
a disease or condition requires an administrative
regulation change under APA. The APA does permit adoption
of emergency regulations, but requires a 5-day public
notice, and emergency regulations can only remain in effect
for up to 180 days.
Confidential public health records
According to CDPH, all HIV/AIDS case reports and any
information collected or maintained in the course of
surveillance-related activities that may directly or
indirectly identify an individual are considered
confidential public health record(s) under California
Health and Safety Code (HSC) Section 121035(c) and must be
handled with the utmost confidentiality. Furthermore, HSC
121025(a) prohibits the disclosure of HIV/AIDS-related
public health records that contain any personally
identifying information to any third party, unless
authorized by law for public health purposes, or by the
written consent of the individual identified in the record
or his/her guardian/conservator.
Except as permitted by law, any person who negligently
discloses information contained in a confidential public
health record to a third party is subject to a civil
penalty of up to $2,500 plus court costs. Any person who
willfully or maliciously discloses the content of a public
health record, except as authorized by law, is subject to a
civil penalty of $5,000 to $10,000 plus court costs. Any
willful, malicious, or negligent disclosure of information
contained in a public health record in violation of state
law that results in economic, bodily, or psychological harm
to the person named in the record is a misdemeanor,
punishable by imprisonment for a period of up to one year
and/or a fine of up to $25,000 plus court costs. Each
disclosure in violation of California law is a separate,
actionable offense.
Because an assurance of case confidentiality is the
foremost concern of the California Department of Public
Health, Office of AIDS (OA), employees are required to sign
STAFF ANALYSIS OF ASSEMBLY BILL 2786 (Committee on Health)
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a Confidentiality Agreement. In the event of any suspected
breach, staff immediately notify the director or supervisor
of the local health department's HIV/AIDS surveillance unit
who in turn notify the Chief of the HIV/AIDS Case Registry
Section or designee. OA, in conjunction with the local
health department and the local health officer promptly
investigate the suspected breach. Any evidence of an actual
breach is reported to the law enforcement agency that has
jurisdiction.
HIV/AIDS funding
California switched to name-based reporting in 2006 in
order to not risk major losses of federal Ryan White Act
funding. The state has since been in a transition period
between code-based reporting and full name-based reporting.
According to CDPH estimates, California's failure to be
fully name-based in HIV reporting, meant the loss of $3
million to $7 million in federal funding in 2009.
According to the LAO, only about 36,000 cases of HIV have
been reported by name to local health jurisdictions. This
number likely represents only one-third to one-half of HIV
cases statewide. According to the LAO, California could
potentially increase receipt of federal Ryan White Act
funding by several million to low tens of millions of
dollars annually simply by increasing the number of HIV
infections reported.
California spends roughly $1.2 billion a year (40 percent
GF) on medical treatment and HIV/AIDS programs. The Ryan
White Act provides $125 million in federal funding per year
to California. Increased federal funds would likely be used
to reduce GF spending for the treatment of the disease.
Related bills
AB 2541 (Portantino) of 2010 would delete the exemption
from electronic reporting for
HIV infections and would make conforming changes. The bill
would provide that health care providers and laboratories
report cases of HIV infection to the local health officer
using patient names and set guidelines regarding such
reports. Pending in the Senate Health Committee.
Prior legislation
SB 541 (Alquist) Chapter 605, Statues of 2008, requires
STAFF ANALYSIS OF ASSEMBLY BILL 2786 (Committee on Health)
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health care facilities to prevent unlawful or unauthorized
access to, use, or disclosure of, patients' medical
information and to establish safeguards to protect the
privacy of patients' medical information. Authorizes CDPH
to levy administrative penalties against facilities for
failure to prevent unlawful or unauthorized access, use, or
disclosure of patients' medical information, and for
failure to report instances of unlawful or unauthorized
access, use, or disclosure of information.
AB 211 (Jones) Chapter 602, Statutes of 2008, requires
every provider of health care to implement appropriate
specified safeguards to protect the privacy of a patient's
medical information. The bill would require every provider
of health care to reasonably safeguard confidential medical
information from unauthorized or unlawful access, use, or
disclosure.
SB 356 (Negrete McLeod) of 2007 would have required CDPH to
establish a list of communicable diseases and conditions
for which clinical laboratories are required to submit
specimens to the local public health laboratory and state
public health laboratory for further testing. This bill
would have permitted the list to be modified by CDPH at any
time, in consultation with the California Conference of
Local Health Officers, and to exempt the modifications from
APA regulation change and rulemaking requirements. SB 356
was vetoed by Governor Schwarzenegger because the delay in
passing the 2008-2009 state budget forced him to prioritize
the bills sent to his desk.
AB 682 (Berg), Chapter 550, Statutes of 2007, revised the
written and informed consent standards associated with
testing blood for the human immunodeficiency virus (HIV),
including prenatal HIV testing, to no longer require
affirmative approval prior to administering an HIV test.
Established the new HIV testing consent standard as the
right to decline the test.
SB 699 (Soto), Chapter 20, Statutes of 2006, required
health care providers and laboratories to report HIV cases
by the patient's name rather than code in order to comply
with federal funding requirements.
AB 1091 (Negrete McLeod), Chapter 262, Statutes of 2003,
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allows CDPH, in consultation with the California Conference
of Local Health Officers, to modify the list of reportable
diseases that health care providers are required to report.
CDPH can modify this list at any time without having to
comply with APA requirements.
PRIOR ACTIONS
Assembly Health: 18-0
Assembly Appropriations: 15-0
Assembly Floor: 74-0
Senate Health: 8-0
Senate Appropriations:11-0
COMMENTS
1. Senate Floor amendments. When this bill passed the
Senate Health Committee on June 30, 2010, the bill: a)
allowed CDPH to modify the list of communicable diseases
and conditions for which clinical labs must submit
specimens to the local public health laboratory to undergo
further testing; and b) allowed CDPH to modify the list at
any time, in consultation with the CCLHO and the CAPHLD.
Recent Senate Floor amendments:
a. Authorize specified disclosures of public health
records relating to human
immunodeficiency virus (HIV) or acquired immune
deficiency syndrome (AIDS)
between specified local public health agency staff,
health care providers, specified
state public health agency staff, and HIV positive
individuals who are the subject of
the records, for the purposes of enhancing
completeness of STD reporting to the
federal Centers for Disease Control and Prevention
(CDC) and offering and
coordinating care and treatment services to HIV
positive persons;
b. Increase the penalties for negligent, willful or
malicious disclosure of content of any
confidential public health record to a third party,
except as otherwise authorized by
law; and,
STAFF ANALYSIS OF ASSEMBLY BILL 2786 (Committee on Health)
Page 11
c. Add contingent language to avoid chaptering out
provisions in AB 2541 (Portantino and Fletcher).
POSITIONS
Support: Health Officers Association of California
(sponsor)
Oppose: None received
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