BILL NUMBER: SB 357	INTRODUCED
	BILL TEXT


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 introduced, 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 require the oversight committee to conduct its
final report by July 31, 2013, and 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
intitial results of the PCI pilot program. 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.
   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 3)
without evidence for active ischemia, recent cardiovascular attack,
advanced malignancy, 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;
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 tortuoisty 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  at the conclusion of the pilot
program   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)  The   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. The  report shall
be submitted no later than 90 days after termination of 
 department may continue to implement  the pilot program
until the Legislature   enacts subsequent legislation to
permanently authorize or end the pilot program  . 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.

   (k) This section shall remain in effect only until January 1,
2014, allowing up to two years for implementation and at least three
years during which the pilot program will be operational. As of
January 1, 2014, this section is repealed, unless a later enacted
statute, that is enacted before January 1, 2014, deletes or extends
that date.  
   (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). 
  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.