BILL ANALYSIS �
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 186
A
AUTHOR: Williams
B
AMENDED: March 30, 2011
HEARING DATE: June 8, 2011
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CONSULTANT:
8
Orr
6
SUBJECT
Reportable diseases and conditions
SUMMARY
Permits 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).
CHANGES TO EXISTING LAW
Existing law:
Requires CDPH to establish a list of diseases and
conditions which local health officers are required to
report to CDPH. The list may include both communicable and
noncommunicable diseases, and is required to include, but
not be limited to, diphtheria, listeria, Salmonella,
shigella, streptococcal infection in food handlers or dairy
workers, and typhoid. Allows CDPH to modify this list in
consultation with CCLHO and exempts this modification from
Continued---
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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.
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.
This bill:
Requires CDPH to establish a list of communicable diseases
and conditions for which clinical laboratories must submit
a culture or a specimen to the local public health
laboratory to undergo further study. 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
list and any modifications to the list with the Secretary
of State for publication in the CCR.
Deletes specific diseases that are enumerated in law as
mandatory reportable diseases.
Exempts from civil and criminal penalties any person or
facility that fails to submit a culture or specimen as
required, unless the disease or condition for which a
culture or specimen is required has been printed in the CCR
and the department has notified the person or facility of
the disease or condition at least six months prior to the
date of the failure to report.
Makes legislative findings and declarations regarding the
need to enable prompt identification of a disease outbreak,
send positive specimens to the public health laboratory for
identification, and enable CDPH to assess newly emerging
diseases and conditions in a timely manner.
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FISCAL IMPACT
The Assembly Appropriations Committee Analysis estimates
minor absorbable costs to CDPH to establish and modify the
list of required specimens.
BACKGROUND AND DISCUSSION
The author has introduced this bill in order to allow CDPH
to quickly add conditions to the list of diseases for which
clinical laboratories are required to submit samples to
public health laboratories. The department is currently
not permitted to add or delete diseases for which samples
need to be submitted to public health laboratories, even in
a public health emergency, without going through a lengthy
regulatory change process under the APA. Current California
regulations require clinical laboratories to submit to
public health laboratories the isolates for Salmonella and
Mycobacterium tuberculosis, as well as blood smears for
malaria. Other isolates or clinical specimens are
submitted to public health laboratories on a voluntary
basis. However, making the submission of samples voluntary
does not ensure a large enough sample size to detect common
source outbreaks.
The author claims it is common for clinical laboratories in
California to not perform the additional tests that are
necessary to allow public health officials to type and
identify clusters of cases revealing a common source
outbreak. The sponsor cites the 2006 E. coli outbreak in
California-grown spinach as an example of an outbreak that
could have been stemmed more quickly with the reporting
changes contained in SB 186. By allowing CDPH to quickly
add conditions to the list of diseases for which clinical
laboratories must submit isolates, AB 186 may save lives
during an emergency.
Communicable disease reporting and surveillance
California has a dual reporting system for communicable
diseases. Both health care providers (physicians) and
laboratories are required to report a case, or suspected
case, of certain listed diseases to public health
officials. Both are responsible for reporting dozens of
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named conditions, as well as any outbreaks of unusual
diseases, within a specified timeframe of identifying the
disease. Laboratories report these specific conditions to
the LHD, based on the location of the physician's office.
Once the LHD receives a laboratory disease report for a
suspected or confirmed case, it notifies the appropriate
public health staff to manage and track the case. LHDs then
report disease case information directly to the state.
Public health officials use disease reporting to monitor
public health, develop prevention strategies, set
priorities and evaluate programs, allocate resources and
facilitate research. While there are many surveillance
strategies, disease reporting originating from health care
providers and laboratories is at the core of surveillance.
Clinical laboratories
In addition to reporting a case, or suspected case, of any
disease or condition on the CDPH list to the local health
officer of the jurisdiction where the patient resides,
health care providers are required to send specimens to a
clinical laboratory when applicable. Clinical laboratories
include all hospital laboratories and community
laboratories that receive tests from health care providers
for analysis. Under regulation, labs are 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 administrative regulations. The APA does permit
adoption of emergency regulations for this purpose, but
requires a 5-day public notice, and emergency regulations
can only remain in effect for up to 180 days.
Foodborne disease outbreaks and disease subtyping
Twenty years ago, most foodborne outbreaks were local
problems that typically resulted from improper
food-handling practices, most often associated with
individual restaurants or social events, and often came to
the attention of local public health officials through
calls from affected persons. According to the Centers for
Disease Control (CDC) today, foodborne disease outbreaks
commonly involve widely distributed food products that are
contaminated before distribution, resulting in cases that
are spread over several states or countries. It is less
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common for ill persons to know others who are ill, or to be
able to identify a likely source of their infection. For
these reasons, it is becoming increasingly important to be
able to identify potential common exposures.
Molecular subtyping has been successfully applied to aid
epidemiologic investigations of foodborne disease,
according to the CDC. For foodborne outbreak surveillance
to be effective, the CDC claims that samples must be
subtyped routinely and the data analyzed promptly at the
local level. Clusters can often be detected locally that
could not have been identified by traditional epidemiologic
methods alone. This is especially true of infections with
common pathogens such as S. Typhimurium (Salmonella), which
occur so frequently that clusters may be difficult to
detect. Clustering of unrelated cases is not uncommon, and
without molecular subtyping, valuable public health
resources can be wasted investigating pseudo-outbreaks.
E. coli
According to the CDC, Shiga toxin-producing Escherichia
coli (STEC) are a leading cause of bacterial intestinal
infections in the United States. STEC transmission occurs
through consumption of a wide variety of contaminated
foods, including undercooked ground beef, unpasteurized
juice, raw milk, and raw produce (e.g., lettuce, spinach,
and alfalfa sprouts); through ingestion of contaminated
water; through contact with animals or their environment;
and directly from person to person (e.g., in child-care
settings). Prompt, accurate diagnosis of STEC infection is
important because appropriate treatment early in the course
of infection might decrease the risk for serious
complications such as renal damage and improve overall
patient outcome. In addition, prompt laboratory
identification of STEC strains is essential for detecting
new and emerging serotypes, for effective and timely
outbreak responses and control measures, and for monitoring
trends in disease epidemiology.
Prior legislation
AB 2541 (Portantino) Chapter 470, Statutes of 2010, deleted
the HIV exemption from authorized electronic reporting in
order to increase federal funding provided to California
for HIV and AIDS services. Explicitly provided disclosure
authority to state and local public health personnel for
the purpose of providing complete information regarding
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sexually transmitted disease surveillance to the federal
government.
AB 2786 (Committee on Health) of the 2009 - 2010 Session
would have required CDPH to establish a list of
communicable diseases and conditions for which clinical
laboratories are required to submit a culture or specimen
to local and state public health laboratories, as
specified. AB 2786 was vetoed by the governor, with the
message: "This bill is overly broad and unnecessary. The
Department of Public Health, in a public health emergency,
already has broad authority to request and receive
laboratory data. I am also concerned that the Department,
without such a public health emergency, could enact changes
that affect both private and public laboratories without
any regulatory oversight."
SB 356 (Negrete McLeod) of the 2007-2008 Session 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 1091 (Negrete McLeod), Chapter 262, Statutes of 2003,
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: 19- 0
Assembly Appropriations:16- 0
Assembly Floor: 73- 0
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POSITIONS
Support: Health Officers Association of California
(sponsor)
AFSCME
Oppose: None received.
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