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 require the oversight committee to conduct its final report by July 31,
begin delete 2013, andend delete 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 intitialend delete results of the
PCI begin delete pilot programend delete. 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 1256.01 of the Health and Safety Code
2 is amended to read:
(a) The Elective Percutaneous Coronary Intervention
4(PCI) Pilot Program is hereby established in the department. The
5purpose of the pilot program is to allow the department to authorize
6up to six general acute care hospitals that are licensed to provide
7cardiac catheterization laboratory service in California, and that
8meet the requirements of this section, to perform scheduled,
9elective percutaneous transluminal coronary angioplasty and stent
10placement for eligible patients.
11(b) For purposes of this section, the following terms have the
13(1) “Elective Percutaneous
Coronary Intervention (elective
14PCI)” means scheduled percutaneous transluminal coronary
15angioplasty and stent placement. Elective PCI does not include
16urgent or emergent PCI that is scheduled on an ad hoc basis.
17(2) “Eligible hospital” means a general acute care hospital that
18has a licensed cardiac catheterization laboratory and is in
19compliance with all applicable state and federal licensing laws and
21(3) “Interventionalist” means a licensed cardiologist who meets
22the requirements for performing elective PCI at a pilot hospital.
23(4) “Pilot hospital” means a hospital participating in the Elective
24Percutaneous Coronary Intervention (PCI) Pilot Program
25established by this section.
26(5) “Primary percutaneous coronary intervention (primary PCI)”
27means percutaneous transluminal coronary angioplasty and stent
P3 1 placement that is emergent in nature for acute myocardial infarction
2and that is performed before administration of thrombolytic agents.
3(6) “Receiving hospital” means a licensed general acute care
4hospital with cardiac surgery services that has entered into a
5transfer agreement with a pilot hospital.
6(7) “STEMI” means ST segment elevation myocardial infarction,
7a type of heart attack, or myocardial infarction, that is caused by
8a prolonged period of blocked blood supply, which affects a large
9area of the heart muscle, and causes changes on an
10electrocardiogram and in the blood levels of key chemical markers.
11(8) “Transfer agreement” means an agreement between the
12eligible hospital and the receiving hospital that meets all of the
13requirements of this section.
14(c) To participate in the pilot program, an eligible hospital shall
15demonstrate that it complies with the recommendations of the
16SCAI for performance of PCI without onsite cardiac surgery, as
17those recommendations may evolve over time, and meets all of
18the following criteria:
19(1) Performs at least 36 primary PCI procedures annually, has
20the capacity to perform at least 200 primary and elective PCI
21procedures annually, and by year two of participation in the pilot
22program, actually performs at least 200 primary and elective
23procedures, including at least 36 primary PCI procedures.
24(2) Has an on-call schedule with operation of the cardiac
25catheterization laboratory 24 hours per day, 365 days per year.
26(3) Performs primary PCI as the treatment of first choice for
27STEMI, and has policies and procedures that require the tracking
28of door-to-balloon times, with a goal of 90 minutes or less, and
29requires that outlier cases be carefully reviewed for process
31(4) Permits only interventionists who meet the following
32requirements to perform elective PCI under the pilot program:
33(A) Perform at least 100 total PCI procedures per year, including
34at least 18 primary PCI per year.
35(B) Have lifetime experience of at least 500 total PCI procedures
36as primary operator.
37(C) Have complication rates and outcomes equivalent or superior
38to national benchmarks established by the American College of
P4 1(D) Hold board certification by the American Board of Internal
2Medicine in Interventional Cardiology and Cardiovascular
4(E) Actively participate in the eligible hospital’s quality
6(5) Employs experienced nursing and technical laboratory staff
7with training in interventional laboratories. Cardiac catheterization
8laboratory personnel must have demonstrated competency treating
9acutely ill patients with hemodynamic and electrical instability.
10(6) Employs experienced intensive care
unit nursing staff who
11have demonstrated competency with invasive hemodynamic
12monitoring, temporary pacemaker operation, and intraaortic balloon
13pump management. Nursing personnel must be capable of
14managing endotracheal intubation and ventilator management both
15onsite and during transfer, if necessary. The eligible hospital shall
16demonstrate sufficient staffing capacity in the intensive care unit
17to provide posttreatment care for patients undergoing elective PCI.
18(7) Has a well-equipped and maintained cardiac catheterization
19laboratory with high resolution digital imaging capability and
20intraaortic balloon pump support compatible with transport
21vehicles. The ability for the real-time transfer of images and
22hemodynamic data via T-1 transmission line as well as audio and
23video images to review terminals for consultation at the receiving
24hospital is ideal.
25(8) Has an appropriate inventory of interventional equipment,
26including guide catheters, balloons, and stents in multiple sizes,
27throbectomy and distal protection devices, covered stents,
28temporary pacemakers, and pericardiocentesis trays. Pressure wire
29devices and intravascular ultrasound equipment are optimal, but
31(9) Provides evidence showing the full support from hospital
32administration in fulfilling the necessary institutional requirements,
33including, but not limited to, appropriate support services such as
34respiratory care and blood banking.
35(10) Has a written transfer agreement for the emergency transfer
36of patients to a facility with cardiac surgery services. Transport
37protocols shall be developed and tested a minimum of twice per
38year, and must ensure the immediate and efficient transfer of
39patients, within 60 minutes, 24 hours per day, seven days per week,
40from the eligible hospital to the receiving hospital. The time for
P5 1transfer of patients shall be calculated from the time it is
2determined that transfer of a patient for emergency cardiac surgery
3is necessary at the eligible hospital, to the time that the patient
4arrives at the receiving hospital.
5(11) Has onsite rigorous data collection, outcomes analysis,
6benchmarking, quality improvement, and formalized periodic case
8(12) Participates in the American College of
9Cardiology-National Cardiovascular Data Registry.
evidence in its application that demonstrates the
11use of rigorous case selection for patients undergoing elective PCI.
12Patient selection criteria will meet all of the following
13requirements, or otherwise be consistent with the recommendations
14of the SCAI, as those recommendations may evolve.
15(A) Patient selection shall be based on the interventionalist’s
16professional medical judgment, which may include, but is not
17limited to, consideration of the patient’s risk, the patient’s lesion
18risk, and the patient’s overall health status.
19(B) For purposes of this section, “patient risk” means the
20expected clinical risk in case of occlusion or other serious
21complication caused by the procedure. “High patient risk” may
22include, but is not limited to, patients with any of the following
23features: decompensated congestive heart failure (Killip class
begin delete 3)end delete
24 without evidence for active ischemia, recent cardiovascular
25attack, advanced malignancy, known clotting disorders; left
26ventricular ejection fraction less than or equal to 25 percent; left
27main stenosis greater than or equal to 50 percent or three-vessel
28disease unprotected by prior bypass surgery greater than 70 percent
29stenosis in the proximal segment of all major epicardial coronary
30arteries; single target lesion that jeopardizes over 50 percent
31of remaining viable myocardium.
32(C) For purposes of this section, “lesion risk” means the
33probability that the procedure will cause acute vessel occlusion or
34other serious complication. “High lesion risk” may include, but is
35not limited to, lesions in open vessels with any of the following
36characteristics: diffuse disease (greater than 2 cm in length) and
begin delete tortuoistyend delete of proximal segments; more than
38moderate calcification of a stenosis or proximal segments; location
39in an extremely angulated segment (greater than 90 percent);
40inability to protect major side branches; degenerated older vein
P6 1grafts with friable lesions; substantial thrombus in the vessel or at
2the lesion site; and any other feature that may, in the
3interventionalist’s judgment, impede stent deployment.
4(D) In evaluating patient risk and lesion risk to determine patient
5eligibility for inclusion in the pilot program, the interventionalist
6shall apply the strategy set forth by the SCAI as set forth below,
7or as it may otherwise evolve:
8(i) A high-risk patient with a high-risk lesion shall not be
9included in the pilot program.
10(ii) A high-risk patient with a not high-risk lesion may be
11included in the pilot program upon confirmation that a cardiac
12surgeon and an operating room are immediately available if
14(iii) A not high-risk patient with a high-risk lesion may be
15included in the pilot program.
16(iv) A not high-risk patient with a not high-risk lesion may be
17included in the pilot program.
18(14) Will include evidence of institutional review board (IRB)
19approval of its participation in the pilot program for as long as
20ACC/AHA/SCAI guidelines categorize elective PCI with offsite
21cardiac surgery as a Class III indication.
22(15) Shall demonstrate evidence of the process for obtaining
23written informed consent from patients prior to undergoing elective
24PCI. The application shall include a copy of the eligible hospital’s
25informed consent form applicable to elective PCI. Evidence of
26IRB approval of the informed consent form will also be provided
27for as long as ACC/AHA/SCAI guidelines categorize elective PCI
28with offsite cardiac surgery a Class III indication.
29(d) Consistent with this section, the department shall invite
30eligible hospitals to submit an application to participate in the
31Elective PCI Pilot Program. The applications shall include
32sufficient information to demonstrate compliance with the
33standards set forth in this section, and additionally include the
34effective date for initiating elective PCI service, the general service
35area, a description of the population to be served, a description of
36the services to be provided, a description of backup emergency
37services, the availability of comprehensive care, and the
38qualifications of the general acute care hospital providing the
39emergency treatment. The department may require that additional
40information be submitted with the application. Failure to include
P7 1any required criteria or additional information shall disqualify the
2applicant from the application process and from consideration for
3participation in the pilot program. The department may select up
4to six general acute care hospitals for participation in the Elective
5PCI Pilot Program based on the applicant’s ability to meet or
6exceed the criteria described in this section.
7(e) An advisory oversight committee comprised of one
8interventionalist from each pilot hospital, an equal number of
9cardiologists from nonpilot hospitals, and a representative of the
10department shall be created to oversee, monitor, and make
11recommendations to the department concerning the pilot program.
12In designating the cardiologists from nonpilot hospitals to the
13committee, the department shall consider the recommendations of
14the California Chapter of the American College of Cardiology.
15The advisory oversight committee shall submit at least two reports
16to the department during the pilot period. The oversight committee
17shall conduct a final report by July 31, 2013, including
18recommendations for the continuation or termination of the pilot
20(f) If at any time a pilot hospital fails to meet the criteria set
21forth in this section for being a pilot hospital or fails to safeguard
22patient safety, as determined by the department, that pilot hospital
23shall be removed from participation in the pilot program by the
25(g) Each pilot hospital shall provide quarterly reports to the
26department and the oversight committee that include statistical
27data and patient information relating to the number of elective PCI
28procedures performed, the interventionalists performing elective
29PCI procedures, and the outcomes of those procedures. In addition,
30pilot hospitals shall include in the report recommendations, if any,
31for modifications to the pilot program and any other information
32the pilot hospitals deem relevant for evaluating the success of the
33pilot program in delivering improved patient care. The department
34and the oversight committee may make site visits to any pilot
35hospital at any time.
36(h) Notwithstanding Section 10231.5 of the Government Code,
37within 90 days of receiving the final report of the oversight
38 committee, the department shall prepare and submit a report to the
39Legislature, pursuant to Section 9795 of the Government Code,
40on the initial results of the Elective PCI Pilot Program.
begin delete The
P8 1 department may continue to implement the pilot program until the
2Legislature enacts subsequent legislation to permanently authorize
3or end the pilot program.end delete
4limited to, an evaluation of the pilot program’s cost, safety, and
5quality of care. The report shall also include a comparison of
6elective PCI performed in connection with the Elective PCI Pilot
7Program, and elective PCI performed in hospitals with onsite
8cardiac surgery services. The report shall further recommend
9whether elective PCI without onsite cardiac surgery should be
10continued in California, and if so, under what conditions.
11(i) The department may charge pilot hospitals a supplemental
12licensing fee, the amount of which shall not exceed the cost to the
13department of overseeing the pilot program.
14(j) The department may contract with a professional entity with
15medical program knowledge to meet the requirements of this
17(k) It is the intent of
the Legislature to enact subsequent
18legislation to act upon the recommendations of the department
19submitted to the Legislature pursuant to subdivision (h).
This act is an urgency statute necessary for the
24immediate preservation of the public peace, health, or safety within
25the meaning of Article IV of the Constitution and shall go into
26immediate effect. The facts constituting the necessity are:
27In order to ensure continued operation of a successful program
28that is saving lives, it is necessary that this act take effect