BILL ANALYSIS �
SB 276
Page 1
SENATE THIRD READING
SB 276 (Corbett)
As Amended September 2, 2011
2/3 vote. Urgency
SENATE VOTE :Vote not relevant
AGRICULTURE
(vote not relevant)
SUMMARY : Requires the Department of Public Health (DPH) to
promulgate regulations regarding the type of medical procedures
which can be performed in the cardiac catheterization laboratory
of a hospital that also has on-site cardiac surgery services,
and allows hospitals to perform certain specified procedures
until such regulations are adopted. Specifically, this bill :
1)Requires DPH to adopt regulations regarding the types of
diagnostic and therapeutic procedures that can be conducted in
a cardiac catheterization laboratory of a general acute care
hospital that maintains a cardiac surgery service.
2)Permits, until regulations are adopted, a general acute care
hospital that maintains a cardiac surgery service to provide
diagnostic and therapeutic services in its cardiac
catheterization laboratory within the following categories:
a) Percutaneous coronary and electrophysiological
interventions, including, but not limited to, emergency and
elective coronary and peripheral stent insertions;
b) Peripheral angiography, interventional radiology
procedures, neuroangiography and neurointerventional
procedures;
c) Surgical interventions, including, but not limited to,
insertion of permanent pacemakers provided the cardiac
catheterization laboratory meets, at a minimum, the Office
of Statewide Health Planning and Development standards
contained in the 1995 California Building Code, or
subsequent edition, for surgery applicable to a cardiac
catheterization laboratory in a general acute care hospital
that maintains a cardiac surgery service, and a safe
operating environment consistent with standards of the
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Association of Perioperative Registered Nurses,
Perioperative Standards and Recommended Practices in effect
as of September 1, 2011;
d) Non-cardiac interventions, including, but not limited
to, orthopedic procedures, gastroenterology endoscopy,
drainage procedures, thoracentesis, paracentesis, lumbar
punctures, myelograms, and pain management procedures
provided the general acute care hospital develops,
maintains, and implements policies and procedures for
terminal cleaning and other infection control measures to
be used in the laboratory following, during and after these
interventions; and,
e) Other diagnostic and therapeutic procedures that can be
safely conducted in a cardiac catheterization laboratory in
a general acute care hospital that maintains a cardiac
surgery service, provided the general acute care hospital
first obtains program flexibility in accordance with the
procedures provided in existing regulations.
3)Requires a general acute care hospital that is approved to
provide cardiac catheterization laboratory service to develop,
maintain, and implement policies and procedures governing the
following:
a) Use of the cardiac catheterization laboratory;
b) Measures to ensure patient safety; and,
c) Availability for routine and emergent cardiac
situations.
4)Prohibits cardiac catheterizations from being performed
outside of a general acute care hospital or multispecialty
clinic, as specified, except as provided in existing law.
5)Requires DPH, notwithstanding existing law, to conduct a
16-month pilot program to allow any freestanding cardiac
catheterization laboratory licensed pursuant to existing law,
to perform both diagnostic and therapeutic procedures in
addition to those authorized in existing law.
6)Requires DPH to consult with the existing freestanding cardiac
catheterization laboratories to determine which procedures to
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authorize under the pilot program with the primary goal being
patient safety. Permits DPH to monitor these laboratories
during the pilot program. Requires the laboratories to
provide a list of procedures to DPH for approval prior to
conducting any additional procedures, or adding any additional
procedures to the list.
7)Requires laboratories participating in the pilot program to
report, at a minimum, to DPH after nine months of
participation in the pilot, the number of procedures performed
by type of procedure, the outcome of those procedures, any
unusual occurrences at the laboratory, any adverse events as
defined by DPH and any other information needed to evaluate
the safety of the pilot program. Requires the laboratory to
report to DPH any event or occurrence that affects the health
or safety of patients, staff, or visitors within 72 hours of
the occurrence. Requires DPH to use this information to
develop any proposed legislative changes to the licensing
requirements of existing freestanding cardiac catheterization
laboratories.
8)Permits DPH, as a pilot program of limited scope and duration,
to set additional standards to ensure patient safety and to
gather necessary information on the pilot program. Requires
any freestanding cardiac catheterization laboratory
participating in the pilot program to comply with any
additional standards required by DPH to ensure patient safety,
and provide any additional information requested by DPH
related to this pilot program.
9)Contains an urgency clause to maintain continuity of and
access to state of the art cardiac and vascular
catheterization services.
EXISTING LAW :
1)Provides for the licensure and regulation of health facilities
by DPH.
2)Authorizes health facilities to perform various types of
cardiac surgery.
3)Provides that hospitals which are licensed to provide cardiac
catheterization laboratory services, but which are not
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licensed to provide cardiac surgery, are limited to performing
certain diagnostic and emergency interventional cardiac
procedures.
FISCAL EFFECT : The provisions of this bill have not been
analyzed by a fiscal committee.
COMMENTS : According to the National Heart Lung and Blood
Institute, cardiac catheterization is a common procedure used to
diagnose and treat a wide variety of heart problems in adults
and children. During a cardiac catheterization, the
cardiologist inserts a small, hollow tube (catheter), into an
artery or vein, and then guides it into the heart using an
x-ray. The cardiologist injects contrast (x-ray dye) through
the catheter to outline the arteries and to show any blockages
or a narrowing that may exist. A cardiac catheterization
laboratory is equipped with digital imaging equipment and
computers for fluoroscopy and cineangiogram (movies of the
heart) that allow for precise quantitative evaluation of heart
problems. A diagnostic cardiac catheterization is a
classification of procedures that provides information regarding
the heart chambers and the arteries supplying the heart to
assist cardiologists and cardiac surgeons in diagnosing illness
or disease. A therapeutic catheterization is a classification
of invasive procedures that are intended primarily for the
treatment of cardiac illness and disease. There are currently
approximately 200 cardiac catheterization laboratories operating
in California.
According to the author, DPH recently issued an All Facilities
Letter (AFL) which severely limits the type of procedures which
may be performed in hospital cardiac catheterization
laboratories. According to DPH's AFL, hospitals with in-house
cardiac services are only allowed to perform diagnostic
procedures in their cardiac catheterization laboratories even
when they have on-site surgery services. The author maintains
that the policy outlined in DPH's AFL is a departure from
standard practice. By limiting the ability of cardiac
catheterization laboratories to diagnostic procedures only,
hospitals that would like to provide additional therapeutic
procedures have to apply for and obtain a program flexibility
waiver, requiring inspection by the Office of Statewide Health
Planning and Development (OSHPD) to verify their facilities meet
state standards for operating rooms. Additionally, the author
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maintains DPH's AFL specifies that hospitals with free-standing
cardiac catheterization laboratories (without on-site cardiac
surgery facilities) are allowed to perform only four diagnostic
procedures in their laboratories. Freestanding cardiac
catheterization laboratories cannot be granted a program
flexibility waiver because they do not have the immediate
availability of on-site surgical intervention.
The author argues that the criteria set forth in DPH's AFL
causes a severe inconvenience for hospitals and patients and
also require intensive state resources from both DPH and OSHPD.
The author asserts that this use of resources is unwise
considering that industry standards for in-house cardiac
catheterization laboratories are much higher than those for
regular operating rooms. The author argues further that, prior
to DPH's AFL, hospitals had been performing therapeutic
procedures in their cardiac catheterization laboratories for
decades, in accordance with national standards of practice,
without program flexibility waivers.
This bill, according to the author, will require new regulations
to update and clarify the state law in order to reflect current
practice standards regarding cardiac catheterization
laboratories - standards the author states will allow patients
to continue to receive the safest and most effective care. This
bill allows, until regulations are promulgated, hospitals with
cardiac catheterization laboratories with on-site cardiac
surgery services to perform certain specified diagnostic and
therapeutic procedures. This bill also allows hospitals with
free-standing cardiac catheterization laboratories to apply for
participation in a DPH pilot program to allow services to be
provided beyond the four diagnostic procedures specifically
authorized under current law.
The California Hospital Association (CHA), the sponsor of this
bill, writes in support that this bill is an urgency measure
that addresses varied interpretation of the law to allow
hospitals to continue to provide cardiac catheterization
services that have a track record of being safely performed in
California, and across the nation. CHA states that regulations
are appropriate because rules about cardiac catheterization
laboratories in hospitals with on-site surgery services should
be developed with the full input of medical experts, patient
advocates, and other stakeholders in the type of open and public
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process required by the Administrative Procedures Act. CHA
argues, that until regulations are promulgated, a hospital that
maintains an on-site cardiac surgery service should continue to
provide diagnostic and therapeutic services in its cardiac
catheterization laboratory as long as services are consistent
with the most current state standards.
The United Nurses Association of California/American Federation
of State County and Municipal Employees (UNAC/AFSCME) is opposed
unless amended to the use of program flexibility for cardiac
catheterization laboratories in hospitals. According to
UNAC/AFSCME, program flexibility in the past has been used to
waive staffing requirements, including nurse ratios and other
provisions of regulation regarding staffing. UNAC/AFSCME also
maintains that program flexibility has been used to override
requirements related to acuity classification systems and the
organization has concerns about hospital infections. For these
reasons, UNAC/AFSCME is requesting amendments that prohibit
program flexibility from being granted with respect to staffing
requirements, acuity systems, infection control or hospital
acquired infections.
The California Nurses Association (CNA) is opposed to this bill
due to patient safety concerns. CNA states that state oversight
including the current survey and inspection process has been put
in place to ensure that hospitals comply with state laws and
regulations. CNA argues that amending this process and allowing
certain invasive cardiac catheterization procedures to be
performed outside of the operating room, without state
oversight, may unnecessarily jeopardize patient safety. CNA is
also opposed to the program flexibility provisions of this bill
for the same reasons stated by UNAC/AFSCME.
Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916)
319-2097
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