BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Deborah V. Ortiz, Chair
BILL NO: SB 1301
S
AUTHOR: Alquist
B
AMENDED: April 6, 2006
HEARING DATE: April 19, 2006
1
FISCAL: Appropriations
3
0
CONSULTANT:
1
Hansel / ag
SUBJECT
Health facilities: reporting and inspection requirements
SUMMARY
Makes modifications in the staffing and systems analysis
that DHS uses to determine annual licensing fees for health
facilities. Requires the Department of Health Services
(DHS) to ensure that periodic inspections of health
facilities are not announced, and to inspect for compliance
with state laws and regulations during periodic
inspections. Requires general acute care, acute
psychiatric, and special hospitals to report adverse
events, as defined, to DHS. Requires DHS to conduct onsite
inspections or investigations of adverse events and
complaints involving general acute care, acute psychiatric,
or special hospitals within specified timelines, and
requires the department to conduct periodic unannounced
inspections not less than once per year of health
facilities that have reported adverse events. Requires DHS
to provide, on the department's website and in written
form, information regarding complaints and reported adverse
events. Allows DHS to assess civil penalties against
hospitals that fail to report adverse events as required by
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the bill.
ABSTRACT
Existing law:
1.Requires DHS to inspect, license, and regulate health
care facilities, including general acute care hospitals,
acute psychiatric hospitals, special hospitals, and
skilled nursing facilities.
2.Establishes annual license fees for new licenses and
renewals of licenses of health facilities.
3.Requires DHS, prior to establishing annual fee levels, to
prepare a staffing and systems analysis to justify the
fee levels being proposed.
4.Requires health facilities for which a license or special
permit has been issued to be periodically inspected by a
representative of DHS but exempts certain facilities that
are certified to participate in the federal Medicare and
Medicaid programs from these requirements.
5.Requires general acute care and acute psychiatric
hospitals to be inspected no less than once every three
years, and as often as necessary to ensure the quality of
care being provided.
6.Requires DHS to notify health facilities of all
deficiencies in their compliance with state law and
regulations and requires such facilities to implement a
plan of corrective action, as specified.
7.Allows the Director of DHS (Director) to revoke or
suspend the license, or to order implementation of a plan
of correction, for any health facility that fails to
correct noted deficiencies.
8.Allows the Director to order a reduction in the number of
patients or closure of units posing a risk in response to
any condition within a general acute care, psychiatric,
or special hospital that poses an immediate and
substantial hazard to the health or safety of patients.
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9.Provides that all inspection reports and lists of
deficiencies involving licensed health care facilities
are open to public inspection.
10.Allows the Director to assess a civil penalty not to
exceed $50 per patient per day against health facilities
that fail to correct deficiencies within the time
specified in the facility's plan of corrective action,
for deficiencies that pose an immediate and substantial
hazard to the health or safety of patients.
11.Establishes the public policy of the state of California
to encourage patients, nurses, and other health care
workers to notify government entities of suspected unsafe
patient care and conditions.
Existing DHS regulations and policy:
1.Requires DHS to initiate investigation of complaints that
involve immediate and serious or immediate jeopardy to
patients in licensed health care facilities other than
long-term care facilities within two working days and to
complete its investigation of such complaints within 45
days, and to initiate and complete investigation of
complaints that do not involve immediate and serious or
immediate jeopardy to patients within 75 days.
2.Requires general acute care hospitals and acute
psychiatric hospitals to report unusual occurrences which
threaten the welfare, safety, or health of patients,
personnel, or visitors to the local health officer and to
DHS.
This bill:
1.Requires the staffing and systems analysis that DHS uses
to determine annual licensing fees for health facilities
to demonstrate the department has sufficient surveyors
and other personnel to fulfill the requirements of state
and federal law for timely inspections, complaint
investigations, and investigations of medical errors; and
to provide information on the proportion of inspections
and investigations that were completed in a timely manner
during the preceding year and the waiting times for
change of ownership and new licenses.
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2.Adds special hospitals, defined as hospitals providing
dentistry and maternity services, to the list of
hospitals requiring inspection no less than once every
three years.
3.Requires DHS to ensure that periodic inspections of
health facilities are not announced, and to inspect for
compliance with state laws and regulations during
periodic inspections.
4.Requires general acute care, acute psychiatric, and
special hospitals to report any adverse event, as
defined, to the department no later than five days after
the adverse event has been detected or, if the event is
an urgent or emergent threat to the welfare, health, or
safety of patients, personnel, or visitors, not later
than 24 hours after the adverse event has been detected.
5.Requires DHS to make an onsite inspection or
investigation within 48 hours of the receipt of any
adverse event report, or any complaint involving a
general acute care, psychiatric, or special hospital that
creates a threat of imminent danger of death or serious
bodily harm, and to complete the investigation within 45
days.
6.Requires DHS to complete an investigation of any
complaint that the department determines does not pose a
threat of imminent danger of death or serious bodily harm
to the patient involved or other patients within 45 days.
7.Requires the department to notify the complainant and
licensee of the department's determination as a result of
an inspection or report.
8.Requires the costs of administering the bill's provisions
dealing with investigation and follow-up inspections
related to complaints and reported adverse events to be
paid from licensing fees paid by general acute care and
psychiatric hospitals.
9.Defines an adverse event subject to reporting by a
general acute care, psychiatric, or special hospital as
an unusual occurrence, such as an epidemic outbreak,
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poisoning, fire, major accident, disaster, or other
catastrophe, medical error, or any other unusual
occurrence that threatens the welfare, safety, or health
of patients, personnel, or visitors.
10.Provides that an adverse event includes, but is not
limited to, the following with certain exceptions:
surgeries performed on the wrong body part or
patient;
retention of a foreign object in a patient after
surgery;
death during or up to 24 hours following surgery of
a normal healthy patient;
discharge of an infant to the wrong person;
stage 3 or 4 ulcers acquired after admission to a
facility;
incidents in which oxygen or other lines contain
the wrong or contaminated gas;
care ordered or provided by someone impersonating a
licensed health care provider;
abduction of a patient;
sexual assault of a patient;
deaths or serious disabilities of patients cared
for by the facility associated with:
use of contaminated drugs or devices;
use of a device for a purpose other than that
intended;
intravascular air embolism;
patient disappearance for more than four hours,
excluding patients who have decision-making capacity;
suicide or attempted suicide;
medication errors;
hemolytic reactions due to administration of
ABO-incompatible blood or blood products;
labor or delivery in low-risk pregnancies;
onset of hypoglycemia;
failure to identify and treat hyperbilirubinemia in
neonates;
electric shock;
burns;
falls;
use of restraints or bedrails; and
physical assaults.
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11.Requires hospitals subject to the adverse event
reporting requirement to inform the patient or
responsible party of the adverse event report at the time
the report is made.
12.Requires the department to conduct an unannounced
inspection not less than once per year of any health
facility that has reported an adverse event, or until the
facility has demonstrated that the adverse event has been
resolved.
13.Requires the department to provide by January 1, 2009,
information regarding the outcomes of inspections and
investigations of reported adverse events and serious
complaints on the department's website, and in a written
form that is accessible to consumers, but that protects
patient confidentiality.
14. Requires the information provided by the department to
include information on each reported adverse event and
provides that it may include facility compliance history.
15.Allows the department to assess a civil penalty not to
exceed $100 per day for each day a hospital fails to
report a medical error that it is otherwise required to
report within 48 hours and specifies procedures for a
hospital to appeal any penalty.
FISCAL IMPACT
Unknown costs to DHS, paid from hospital licensing fees, to
investigate adverse event reports and complaints involving
general acute care, psychiatric, and special hospitals,
inspect hospitals that report adverse events, and to post
information as required by the bill.
BACKGROUND AND DISCUSSION
Background
The author has introduced SB 1301 to ensure that the state
has a system in place for early detection of and response
to systemic problems that cause medical errors leading to
death or serious injuries of patients in hospitals. The
author notes in particular that four patient deaths
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attributable to medical errors have occurred in Santa Clara
County in the past 14 months, involving two hospitals. The
author states that SB 1301 addresses these problems by
establishing a reporting system for the timely reporting of
medical errors in hospitals, increasing the frequency of
licensing inspections of facilities that report serious
medical errors, and requiring the posting of information
about medical errors in hospitals to assist patients in
determining where to seek care.
The author states that SB 1301 also brings standards for
inspection and handling of serious complaints and adverse
events involving hospitals closer to those in place for
nursing and long-term care facilities by reducing the
amount of time for the Department of Health Services to
investigate and respond to serious complaints and medical
errors, requiring unannounced inspections of hospitals
generally, and requiring DHS to post information regarding
the outcomes of inspections and investigations of
hospitals.
In 2002, the National Quality Forum published a report,
Serious Reportable Events in Healthcare, which identified
27 serious but largely preventable adverse events in health
care facilities that might form the basis of a national
state-based event reporting system to produce substantial
improvements in patient care. The report was an attempt to
implement the recommendations of a report by the Institute
of Medicine in 1999, To Err is Human: Building a Safer
Health System, which found that medical errors cause the
death of between 44,000 and 98,000 patients each year in
the US, and recommended that health care errors be reported
in a systematic manner. According to some accounts,
preventable medical errors are the fifth leading cause of
death in the United States.
The 27 adverse events are events that there is consensus
among health care professionals should never occur in
health care facilities, including preventable bedsores,
falls, and surgery on the wrong body part or patient.
In 2003, Minnesota became the first state to pass a statute
mandating reporting by hospitals of the list of 27 adverse
events. Since passage of the law in Minnesota,
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Connecticut, New Jersey, and Illinois have passed similar
reporting laws. The Minnesota statute requires hospitals
to report any of the 27 adverse events and to conduct and
report to the state root cause analyses and corrective
action plans related to the adverse events, and requires
the health commissioner to post information describing, by
hospital, adverse events reported.
In the first report of medical error data in Minnesota,
covering the period July 1, 2003 to October 6, 2004, 30 of
145 licensed hospitals reported 99 instances of the
identified adverse events, resulting in 20 patient deaths
and four serious disabilities. Surgical errors accounted
for slightly more than half of the reported errors, while
falls were the most common cause of death. The most common
error reported was foreign objects left inside patients,
followed by hospital-acquired bedsores. The second report,
covering the time period October 7, 2004 to October 6,
2005, found an increase in reported adverse events from 99
to 106, with a decline in reported deaths but an increase
in reports of serious disability. As in the first report,
surgical errors accounted for half of reported errors.
Trends toward greater patient safety and hospital outcomes
reporting
Medical error reporting systems are part of a broader trend
toward greater measurement of outcomes in hospitals and
health care facilities, use of hospital report cards, and
implementation of quality of care measures. The California
Hospital Assessment and Reporting Taskforce (CHART) is
currently developing data systems and reporting mechanisms
for hospital performance reporting. The Pacific Business
Group on Health is leading a national effort to implement
the Leapfrog initiative, which urges hospitals to implement
patient safety reforms including adoption of computerized
physician order entry, intensive care physician staffing,
and evidence-based hospital referral.
A number of organizations are also developing systems for
reporting of hospital-based infections, including the
National Quality Forum, Joint Commission on Accreditation
of Healthcare Organizations (JCAHO), and CHART. In a
report in April, 2003, To Protect and Prevent: Rebuilding
California's Public Health System, the Little Hoover
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Commission recommended that the state consider mandatory
reporting of health care setting infection data.
The Joint Commission on Accreditation of Health Care
Organizations (JCAHO), which accredits health care
facilities and organizations, recently began requiring
hospitals to report and conduct root cause analyses of
"sentinel events" to encourage hospitals to investigate
errors and to begin a central system for collecting and
analyzing the information. Reporting of such events -
defined as an unexpected occurrence involving death or
serious physical or psychological injury - has lead to
issuance of "sentinel event alerts" from JCAHO regarding
common errors or procedures that have caused patient harm.
The organization has recommended applying this method to
identified near misses as well.
A recent report issued by Health Grades, a national health
care ratings organization, found that between 2002 and
2004, patient safety incidents in American hospitals grew
from 1.18 million to 1.24 million among the 40 million
hospitalizations covered by the Medicare program and that
states vary greatly in the number and frequency of
incidents reported. According to the report, California
ranked 42 among states in terms of the prevalence of
patient safety incidents.
Governor's proposed health facility licensing and
certification reforms
The 2006-07 Governor's Budget proposes to improve licensing
and oversight of licensed health care facilities by
proposing 155 new positions in the DHS Licensing and
Certification Division and $18.9 million ($652,000 General
Fund) to support licensing activities, including timely
investigations of complaints regarding health care
facilities.
The Licensing and Certification Division within DHS is
responsible for ensuring and promoting a high standard of
medical care in approximately 7,000 public and private
health care facilities throughout the state. The
Division's primary responsibilities are to:
Conduct annual certification surveys for participation in
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the federal Medicare and Medicaid (Medi-Cal in
California) programs.
Conduct state licensing reviews and ensure compliance
with state law.
Issue state citations and federal deficiencies, impose
sanctions, and assess monetary penalties on those
facilities that fail to meet certain requirements.
Investigate consumer complaints about health care
facilities and incidents that are self-reported by the
facilities.
According to the Legislative Analyst's Office's analysis of
the Governor's proposed budget for 2006-07, the state's
existing system for licensing and oversight of 7,000 health
care facilities across the state suffers from some serious
weaknesses, including a failure to detect deficiencies
during inspections, poor follow-up when problems are
discovered, a lack of enforcement of state standards, and a
drop in staff productivity.
Related legislation
SB 739 (Speier) - Requires general acute care hospitals
to collect, maintain and report to the Office of
Statewide Health Planning and Development risk-adjusted
data on select hospital-acquired infections. Expresses
legislative intent that certain data be made available to
the public regarding hospital-acquired infections. This
bill is currently on the Assembly Floor.
SB 1780 (Alarcon) - Requires health facilities to report
nosocomial infection data to the Office of Statewide
Health Planning and Development. Requires the Office to
compile this data and establish an aggregate nosocomial
infection rate per health facility and transmit the
aggregate nosocomial infection rate of each health
facility to all applicable local health agencies. This
bill is scheduled to be heard in the Senate Health
Committee on April 26, 2006.
Previous legislation
SCR 49 (Speier, Resolution Chapter 123, Statutes of 2005)
- Creates a panel to study the causes of medication
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errors and recommend changes in the health care system
that would reduce errors associated with the delivery of
prescription and over-the-counter medication to
consumers. The measure would require the panel to
convene by October 1, 2005, and to submit to the Senate
and Assembly Health Committees a report by June 1, 2006.
SB 1487 (Speier) of 2004 - Requires specified hospitals
to have written infection control plans and report to
OSHPD specified data, including the rate of
hospital-acquired infections and risk-adjusted infection
rate data according to the risk-adjustment methodology
determined by the CDC. This bill died on the Senate
Floor.
AB 1461 (Aanestad) of 2001 - Requires the Office of
Statewide Health Planning and Development, in
consultation with an advisory committee, to contract with
an organization recognized as operating a
quality-oriented data base program to create a central
reporting data base and to receive and analyze
information relating to medical events involving the
occurrence or near occurrence of compromises of patient
safety by any health care professional, facility, or
organization licensed by the state. Provisions were not
contained in final version of bill.
AB 893 (Alquist, Chapter 430, Statutes of 1999) -
Requires the Department of Health Services to provide
licensing and compliance history information regarding
long-term care facilities on the Internet.
Arguments in support
The Service Employees International Union (SEIU) states
that it supports SB 1301 because it increases standards for
enforcement in hospitals to be comparable to those in
nursing homes. SEIU notes that there is no statutory
requirement that DHS investigate complaints about hospitals
within a specified period of time; consequently, even
complaints involving patient deaths are often not
investigated for months. SEIU also supports provisions
that assure that DHS will have sufficient staff to survey
and respond to complaints in a timely way and to require
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reporting and response to adverse events in hospitals.
Finally, SEIU states that SB 1301 would be improved if it
also required DHS to determine whether a hospital has
implemented a plan of correction approved by the
department.
The Consumer Attorneys of California (CAOC) states that
patients in California's health facilities are completely
dependent on those facilities for their care. CAOC states
that SB 1301 enhances the oversight of health facilities by
increasing the frequency of inspections of certain
facilities, requiring that inspections be unannounced, and
requiring the reporting and investigation of medical errors
in hospitals.
Protection and Advocacy states that it supports SB 1301
raises inspection requirements for health care facilities
by requiring DHS to inspect to state and federal standards
during periodic inspections and requiring periodic
inspections to be unannounced. P&A states that current
practice in cases where state law is more stringent than
federal law is for inspectors to not cite facilities for
failing to comply with state law if they comply with
federal law. P&A also states that it supports the bill's
provisions increasing the frequency of hospital inspections
and the timeliness of investigations of serious complaints
involving hospitals.
Support if amended
Taking a support if amended position, Kaiser Permanente has
requested several specific amendments to the bill,
including lengthening the time for reporting adverse events
under the bill from 5 days (2 days for more serious events)
to 15 days; more carefully defining adverse events subject
to reporting by hospitals; including language to protect
the identity and confidentiality of health care
professionals and facility employees in the reports of
adverse events that are filed by hospitals; giving DHS
flexibility to defer annual inspections of hospitals
experiencing adverse events in certain cases; and limiting
the focus of inspections of complaints or adverse events to
the specific areas of the facility affected by the
complaint or adverse events.
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Arguments in opposition
Taking an oppose unless amended position, the California
Hospital Association (CHA) states that to improve patient
care hospitals must maintain a blame-free culture to ensure
that staff will report adverse events. Towards that end,
CHA requests amendments to require DHS to post statewide
aggregate data on the website rather than hospital-specific
information, and to provide that information in the reports
is confidential, protected from discovery, and not
admissible in court. CHA states that if there is a
perception of punishment for making an error or reporting
an error it is less likely to be reported. Finally, CHA
notes that it is involved in efforts to provide publicly
reported quality measures for hospitals to assist consumers
such as the California Hospitals Assessment and Reporting
Taskforce (CHART).
The California Medical Association (CMA) states that any
medical error reporting system must be based on voluntary
and anonymous reporting, reporting to a non-regulatory
entity such as the Institute for Medical Quality or Office
of Statewide Health Planning and Development, strict
confidentiality and non-discoverability of the information,
root cause analyses of reported medical errors, and a
feedback mechanism to the health care community. Without
these basic elements, which SB 1301 does not contain,
medical error reporting is ineffective and unlikely to
actually improve patient safety. CMA states that SB 1301
could also lead to increased litigation and the fear of
being sued might actually suppress discussion about medical
errors among providers. CMA also objects to the overly
vague and broad definition of medical error in the bill and
states that as a result, hospitals could be subject to
penalties for failing to report errors that they do not
know are reportable.
The Alliance of Catholic Health Care also has taken an
oppose unless amended position. According to the Alliance,
SB 1301 would replace error reporting with a punitive
regulatory structure that discourages transparency and
improvement and creates a culture of fear and blame. The
Alliance also takes exception to the assumption in the bill
that increased DHS inspections are needed to reduce medical
errors. The Alliance argues that the efficacy of increased
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inspections and regulatory processes needs to be evaluated
against the costs of disruption to the delivery of care to
patients and additional administrative burden for both DHS
and hospitals, and that posting information on the web
about adverse events and the outcomes of inspections and
investigations on a per-hospital basis poses both reporting
and legal discovery concerns. Finally, the Alliance argues
that the definition of "adverse event" in the bill is
overly broad and should be limited to the "never 27"
events.
Concerns
AdvaMed, whose member companies produce medical devices,
diagnostic products, and health information systems, states
that under current FDA requirements, health care facilities
are required to report adverse events relating the
performance of any medical device to the agency, which then
conducts an investigation and determines whether to take
action regarding the device. AdvaMed states that it would
be redundant and confusing if health care facilities are
required to submit a separate report to DHS, and recommends
that the bill be amended to provide, in cases of adverse
events that involve the performance of medical devices,
facilities be allowed to provide DHS with a copy of the
report it submits to the FDA and to defer to the FDA
investigation of the event.
QUESTIONS AND COMMENTS
1.Bill reduces differences in current inspection and
complaint investigation requirements for hospitals and
long-term care facilities. Current law and regulations
treat hospitals and nursing and other long-term care
facilities differently for purposes of inspections and
complaints concerning quality of care. For example,
while hospitals are subject to routine inspections once
every three years, long-term care facilities are subject
to annual inspection (two years for those that have had
no serious licensing violations). While routine hospital
inspections are announced, all inspections of long-term
care facilities are unannounced. In addition, current
statute requires DHS to make an onsite investigation or
inspection of all complaints in long-term care facilities
within 10 days (24 hours for complaints that involve a
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threat of imminent danger of death or serious bodily
harm) whereas there are no statutory timelines for
investigation of complaints involving hospitals.
Finally, DHS is required under current law to provide
public information on citations and complaints, license
suspensions and revocations, and enforcement sanctions
involving long-term care facilities, whereas it is only
required to make inspection reports and records of
deficiencies involving hospitals available for public
inspection. By establishing specific timelines for
response to adverse events and serious complaints in
hospitals, increasing the frequency of inspections of
hospitals that have reported adverse events, and posting
information about adverse events and hospital compliance
history, the bill would make licensing and inspection
procedures for hospitals and long-term care facilities
more similar.
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2.Bill stops short of "blame-free" reporting system for
medical errors. Minnesota's medical error or adverse
event reporting system incorporates several provisions to
insulate hospitals that participate in the system from
both licensing sanctions and civil liability. The law
requires hospitals to report any of the "never 27"
events, as well as root cause analyses and corrective
action plans related to the events, but limits public
disclosure of information related to the events to the
number and types of adverse events by hospital and
aggregate information about corrective action plans and
findings of root cause analyses. Reports of adverse
events also do not include the identities of any health
facility employees or providers. Minnesota also limits
licensing sanctions related to the events, in an effort
to promote a blame-free environment for reporting and
handling of such events. SB 1301 differs from this
framework by requiring hospitals to report adverse
events, including the "never 27" events, requiring DHS to
investigate reported adverse events, and requiring DHS to
inspect more frequently (annually versus once every three
years) hospitals that report adverse events. Under the
approach in SB 1301, DHS could cite and issue
deficiencies as a result of its investigations. In
addition, public information that would be available
would include information about the reported events, as
well as the outcomes of investigations and inspections of
the events.
Current law regarding reporting of adverse events or
unusual occurrences by long-term care facilities provides
that no citation shall be issued for a violation that has
been reported by the licensee to the state department, or
its designee, as an "unusual occurrence," if the
violation has not caused harm to any patient, resident,
or guest; the licensee has promptly taken reasonable
measures to correct the violation and to prevent a
recurrence; and the unusual occurrence report was the
first source of information reported to the state
department, or its designee, regarding the violation.
Should the bill provide that adverse events that are
reported by hospitals that meet criteria similar to these
shall not result in an issuance of deficiencies and shall
not be subject to the public posting requirements of the
bill?
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3.Bill codifies unusual occurrence reporting requirements
for hospitals. Hospitals are currently required to
report as unusual occurrences under DHS regulations,
including epidemic outbreaks, poisoning, fire, major
accident, disaster, other catastrophic or unusual
occurrence which threatens the welfare, safety, or health
of patients, personnel, or visitors. By incorporating
these events under the definition of adverse event, and
adding medical errors and the list of "Never 27" events,
the bill would codify the reporting requirement of
hospitals related to unusual occurrences.
4.Does definition of adverse event need to be further
clarified? Adverse events that hospitals would be
required to report under the bill would include unusual
occurrences of any kind that threaten the welfare,
safety, or health of patients, personnel, or visitors and
would include, but not be limited to, any of the "Never
27" events. Hospitals reportedly currently have
difficulty determining the scope of unusual occurrences
that they are currently required to report under existing
regulations. Should the bill be amended to further
clarify the scope of what is reportable or should the
bill require DHS to develop regulations to further
define?
5.Public disclosure requirements unclear regarding
inspections and investigations related to adverse events.
Under current law, inspection reports and lists of
deficiencies involving licensed health care facilities
are open to public inspection, including those resulting
from complaints and events reported as unusual
occurrences, as well as those resulting from periodic
inspections. Section 1279.3 of the bill provides that
DHS shall provide information regarding the outcomes of
inspections and investigations of adverse events and
complaints that create a threat of imminent danger of
death or serious bodily harm. It is not clear if the
author intends for different information to be available
about inspections and investigations related to adverse
events and serious complaints than would otherwise be
available.
POSITIONS
Support: Congress of California Seniors
Consumer Attorneys of California
Kaiser Permanente (if amended)
Protection and Advocacy, Inc.
Service Employees International Union
Oppose:AdvaMed
Alliance of Catholic Health Care (unless amended)
California Hospital Association
California Medical Association
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