Amended in Senate April 4, 2013

Senate Bill No. 357

Introduced by Senator Correa

February 20, 2013

An act to amend Section 1256.01 of the Health and Safety Code, relating to health facilities, and declaring the urgency thereof, to take effect immediately.

LEGISLATIVE COUNSEL’S DIGEST

SB 357, as amended, Correa. Elective Percutaneous Coronary Intervention (PCI) Pilot Program.

Existing law establishes, until January 1, 2014, the Elective Percutaneous Coronary Intervention Pilot Program in the State Department of Public Health, which authorizes up to 6 eligible acute care hospitals that are licensed to provide cardiac catheterization laboratory service in California, and that meet prescribed, additional criteria to perform scheduled, elective primary percutaneous coronary intervention (PCI), as defined, for eligible patients. Existing law establishes an advisory oversight committee to oversee, monitor, and make recommendations to the department concerning the pilot program. Existing law also imposes various reporting requirements on the advisory oversight committee and the department, including recommendations as to whether the pilot program should be continued or terminated and whether elective PCI without onsite cardiac surgery should be continued in California.

This bill would begin insert extend the pilot program until January 1, 2015, and would end insert require the oversight committee to conduct its final report by July 31, begin delete 2013, and end delete begin insert 2013. The bill end insert would require the department, within 90 days of receiving the final report from the oversight committee, to prepare and submit its report to the Legislature on the begin delete intitial end delete begin insert initial end insert results of the begin insert Elective end insert PCI begin delete pilot program end delete begin insert Pilot Program end insert . begin delete The bill would provide that the department may continue to implement the pilot program until the Legislature enacts subsequent legislation to permanently authorize or end the pilot program. end delete

This bill would declare that it is to take effect immediately as an urgency statute.

Vote: ²⁄₃. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

SECTION 1.  

Section 1256.01 of the Health and Safety Code
is amended to read:

1256.01.  

(a) The Elective Percutaneous Coronary Intervention
(PCI) Pilot Program is hereby established in the department. The
purpose of the pilot program is to allow the department to authorize
up to six general acute care hospitals that are licensed to provide
cardiac catheterization laboratory service in California, and that
meet the requirements of this section, to perform scheduled,
elective percutaneous transluminal coronary angioplasty and stent
placement for eligible patients.

(b) For purposes of this section, the following terms have the
following meanings:

(1) “Elective Percutaneous Coronary Intervention (elective
PCI)” means scheduled percutaneous transluminal coronary
angioplasty and stent placement. Elective PCI does not include
urgent or emergent PCI that is scheduled on an ad hoc basis.

(2) “Eligible hospital” means a general acute care hospital that
has a licensed cardiac catheterization laboratory and is in
compliance with all applicable state and federal licensing laws and
regulations.

(3) “Interventionalist” means a licensed cardiologist who meets
the requirements for performing elective PCI at a pilot hospital.

(4) “Pilot hospital” means a hospital participating in the Elective
Percutaneous Coronary Intervention (PCI) Pilot Program
established by this section.

(5) “Primary percutaneous coronary intervention (primary PCI)”
means percutaneous transluminal coronary angioplasty and stent
placement that is emergent in nature for acute myocardial infarction
and that is performed before administration of thrombolytic agents.

(6) “Receiving hospital” means a licensed general acute care
hospital with cardiac surgery services that has entered into a
transfer agreement with a pilot hospital.

(7) “STEMI” means ST segment elevation myocardial infarction,
a type of heart attack, or myocardial infarction, that is caused by
a prolonged period of blocked blood supply, which affects a large
area of the heart muscle, and causes changes on an
electrocardiogram and in the blood levels of key chemical markers.

(8) “Transfer agreement” means an agreement between the
eligible hospital and the receiving hospital that meets all of the
requirements of this section.

(c) To participate in the pilot program, an eligible hospital shall
demonstrate that it complies with the recommendations of the
SCAI for performance of PCI without onsite cardiac surgery, as
those recommendations may evolve over time, and meets all of
the following criteria:

(1) Performs at least 36 primary PCI procedures annually, has
the capacity to perform at least 200 primary and elective PCI
procedures annually, and by year two of participation in the pilot
program, actually performs at least 200 primary and elective
procedures, including at least 36 primary PCI procedures.

(2) Has an on-call schedule with operation of the cardiac
catheterization laboratory 24 hours per day, 365 days per year.

(3) Performs primary PCI as the treatment of first choice for
STEMI, and has policies and procedures that require the tracking
of door-to-balloon times, with a goal of 90 minutes or less, and
requires that outlier cases be carefully reviewed for process
improvement opportunities.

(4) Permits only interventionists who meet the following
requirements to perform elective PCI under the pilot program:

(A) Perform at least 100 total PCI procedures per year, including
at least 18 primary PCI per year.

(B) Have lifetime experience of at least 500 total PCI procedures
as primary operator.

(C) Have complication rates and outcomes equivalent or superior
to national benchmarks established by the American College of
Cardiology.

(D) Hold board certification by the American Board of Internal
Medicine in Interventional Cardiology and Cardiovascular
Diseases.

(E) Actively participate in the eligible hospital’s quality
improvement program.

(5) Employs experienced nursing and technical laboratory staff
with training in interventional laboratories. Cardiac catheterization
laboratory personnel must have demonstrated competency treating
acutely ill patients with hemodynamic and electrical instability.

(6) Employs experienced intensive care unit nursing staff who
have demonstrated competency with invasive hemodynamic
monitoring, temporary pacemaker operation, and intraaortic balloon
pump management. Nursing personnel must be capable of
managing endotracheal intubation and ventilator management both
onsite and during transfer, if necessary. The eligible hospital shall
demonstrate sufficient staffing capacity in the intensive care unit
to provide posttreatment care for patients undergoing elective PCI.

(7) Has a well-equipped and maintained cardiac catheterization
laboratory with high resolution digital imaging capability and
intraaortic balloon pump support compatible with transport
vehicles. The ability for the real-time transfer of images and
hemodynamic data via T-1 transmission line as well as audio and
video images to review terminals for consultation at the receiving
hospital is ideal.

(8) Has an appropriate inventory of interventional equipment,
including guide catheters, balloons, and stents in multiple sizes,
throbectomy and distal protection devices, covered stents,
temporary pacemakers, and pericardiocentesis trays. Pressure wire
devices and intravascular ultrasound equipment are optimal, but
not mandatory.

(9) Provides evidence showing the full support from hospital
administration in fulfilling the necessary institutional requirements,
including, but not limited to, appropriate support services such as
respiratory care and blood banking.

(10) Has a written transfer agreement for the emergency transfer
of patients to a facility with cardiac surgery services. Transport
protocols shall be developed and tested a minimum of twice per
year, and must ensure the immediate and efficient transfer of
patients, within 60 minutes, 24 hours per day, seven days per week,
from the eligible hospital to the receiving hospital. The time for
transfer of patients shall be calculated from the time it is
determined that transfer of a patient for emergency cardiac surgery
is necessary at the eligible hospital, to the time that the patient
arrives at the receiving hospital.

(11) Has onsite rigorous data collection, outcomes analysis,
benchmarking, quality improvement, and formalized periodic case
review.

(12) Participates in the American College of
Cardiology-National Cardiovascular Data Registry.

(13) Provides evidence in its application that demonstrates the
use of rigorous case selection for patients undergoing elective PCI.
Patient selection criteria will meet all of the following
requirements, or otherwise be consistent with the recommendations
of the SCAI, as those recommendations may evolve.

(A) Patient selection shall be based on the interventionalist’s
professional medical judgment, which may include, but is not
limited to, consideration of the patient’s risk, the patient’s lesion
risk, and the patient’s overall health status.

(B) For purposes of this section, “patient risk” means the
expected clinical risk in case of occlusion or other serious
complication caused by the procedure. “High patient risk” may
include, but is not limited to, patients with any of the following
features: decompensated congestive heart failure (Killip class begin delete 3) end delete
begin insert III) end insert without evidence for active ischemia, recent cardiovascular
attack, advanced malignancy, begin insert or end insert known clotting disorders; left
ventricular ejection fraction less than or equal to 25 percent; left
main stenosis greater than or equal to 50 percent or three-vessel
disease unprotected by prior bypass surgery greater than 70 percent
stenosis in the proximal segment of all major epicardial coronary
arteries; begin insert or a end insert single target lesion that jeopardizes over 50 percent
of remaining viable myocardium.

(C) For purposes of this section, “lesion risk” means the
probability that the procedure will cause acute vessel occlusion or
other serious complication. “High lesion risk” may include, but is
not limited to, lesions in open vessels with any of the following
characteristics: diffuse disease (greater than 2 cm in length) and
excessive begin delete tortuoisty end delete begin insert tortuosity end insert of proximal segments; more than
moderate calcification of a stenosis or proximal segments; location
in an extremely angulated segment (greater than 90 percent);
inability to protect major side branches; degenerated older vein
grafts with friable lesions; substantial thrombus in the vessel or at
the lesion site; and any other feature that may, in the
interventionalist’s judgment, impede stent deployment.

(D) In evaluating patient risk and lesion risk to determine patient
eligibility for inclusion in the pilot program, the interventionalist
shall apply the strategy set forth by the SCAI as set forth below,
or as it may otherwise evolve:

(i) A high-risk patient with a high-risk lesion shall not be
included in the pilot program.

(ii) A high-risk patient with a not high-risk lesion may be
included in the pilot program upon confirmation that a cardiac
surgeon and an operating room are immediately available if
necessary.

(iii) A not high-risk patient with a high-risk lesion may be
included in the pilot program.

(iv) A not high-risk patient with a not high-risk lesion may be
included in the pilot program.

(14) Will include evidence of institutional review board (IRB)
approval of its participation in the pilot program for as long as
ACC/AHA/SCAI guidelines categorize elective PCI with offsite
cardiac surgery as a Class III indication.

(15) Shall demonstrate evidence of the process for obtaining
written informed consent from patients prior to undergoing elective
PCI. The application shall include a copy of the eligible hospital’s
informed consent form applicable to elective PCI. Evidence of
IRB approval of the informed consent form will also be provided
for as long as ACC/AHA/SCAI guidelines categorize elective PCI
with offsite cardiac surgery a Class III indication.

(d) Consistent with this section, the department shall invite
eligible hospitals to submit an application to participate in the
Elective PCI Pilot Program. The applications shall include
sufficient information to demonstrate compliance with the
standards set forth in this section, and additionally include the
effective date for initiating elective PCI service, the general service
area, a description of the population to be served, a description of
the services to be provided, a description of backup emergency
services, the availability of comprehensive care, and the
qualifications of the general acute care hospital providing the
emergency treatment. The department may require that additional
information be submitted with the application. Failure to include
any required criteria or additional information shall disqualify the
applicant from the application process and from consideration for
participation in the pilot program. The department may select up
to six general acute care hospitals for participation in the Elective
PCI Pilot Program based on the applicant’s ability to meet or
exceed the criteria described in this section.

(e) An advisory oversight committee comprised of one
interventionalist from each pilot hospital, an equal number of
cardiologists from nonpilot hospitals, and a representative of the
department shall be created to oversee, monitor, and make
recommendations to the department concerning the pilot program.
In designating the cardiologists from nonpilot hospitals to the
committee, the department shall consider the recommendations of
the California Chapter of the American College of Cardiology.
The advisory oversight committee shall submit at least two reports
to the department during the pilot period. The oversight committee
shall conduct a final report by July 31, 2013, including
recommendations for the continuation or termination of the pilot
program.

(f) If at any time a pilot hospital fails to meet the criteria set
forth in this section for being a pilot hospital or fails to safeguard
patient safety, as determined by the department, that pilot hospital
shall be removed from participation in the pilot program by the
department.

(g) Each pilot hospital shall provide quarterly reports to the
department and the oversight committee that include statistical
data and patient information relating to the number of elective PCI
procedures performed, the interventionalists performing elective
PCI procedures, and the outcomes of those procedures. In addition,
pilot hospitals shall include in the report recommendations, if any,
for modifications to the pilot program and any other information
the pilot hospitals deem relevant for evaluating the success of the
pilot program in delivering improved patient care. The department
and the oversight committee may make site visits to any pilot
hospital at any time.

(h) Notwithstanding Section 10231.5 of the Government Code,
within 90 days of receiving the final report of the oversight
committee, the department shall prepare and submit a report to the
Legislature, pursuant to Section 9795 of the Government Code,
on the initial results of the Elective PCI Pilot Program. begin delete The
department may continue to implement the pilot program until the
Legislature enacts subsequent legislation to permanently authorize
or end the pilot program. end delete The report shall include, but not be
limited to, an evaluation of the pilot program’s cost, safety, and
quality of care. The report shall also include a comparison of
elective PCI performed in connection with the Elective PCI Pilot
Program, and elective PCI performed in hospitals with onsite
cardiac surgery services. The report shall further recommend
whether elective PCI without onsite cardiac surgery should be
continued in California, and if so, under what conditions.

(i) The department may charge pilot hospitals a supplemental
licensing fee, the amount of which shall not exceed the cost to the
department of overseeing the pilot program.

(j) The department may contract with a professional entity with
medical program knowledge to meet the requirements of this
section.

begin delete

(k) It is the intent of the Legislature to enact subsequent
legislation to act upon the recommendations of the department
submitted to the Legislature pursuant to subdivision (h).

end delete begin insert

(k) This section shall remain in effect only until January 1, 2015,
and as of that date is repealed, unless a later enacted statute, that
is enacted before January 1, 2015, deletes or extends that date.

end insert

SEC. 2.  

This act is an urgency statute necessary for the
immediate preservation of the public peace, health, or safety within
the meaning of Article IV of the Constitution and shall go into
immediate effect. The facts constituting the necessity are:

In order to ensure continued operation of a successful program
that is saving lives, it is necessary that this act take effect
immediately.