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 extend the pilot program until January 1, 2015, and would require the oversight committee to conduct its final report by
begin delete July 31, 2013.end delete The bill 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 initial results of the Elective PCI 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 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
28 placement that is emergent in nature for acute myocardial infarction
29and that is performed before administration of thrombolytic agents.
P3 1(6) “Receiving hospital” means a licensed general acute care
2hospital with cardiac surgery services that has entered into a
3transfer agreement with a pilot hospital.
4(7) “STEMI” means ST segment elevation myocardial infarction,
5a type of heart attack, or myocardial infarction, that is caused by
6a prolonged period of blocked blood supply, which affects a large
7area of the heart muscle, and causes changes on an
8electrocardiogram and in the blood levels of key chemical markers.
9(8) “Transfer agreement” means an agreement between the
10eligible hospital and the receiving hospital that meets all of the
11requirements of this section.
12(c) To participate in the pilot program, an eligible hospital shall
13demonstrate that it complies with the recommendations of the
begin delete SCAIend delete for performance of PCI without onsite cardiac surgery, as
16those recommendations may evolve over time, and meets all of
17the following criteria:
18(1) Performs at least 36 primary PCI procedures annually, has
19the capacity to perform at least 200 primary and elective PCI
20procedures annually, and by year two of participation in the pilot
21program, actually performs at least 200 primary and elective
22procedures, including at least 36 primary PCI procedures.
23(2) Has an on-call schedule with operation of the cardiac
24catheterization laboratory 24 hours per day, 365 days per year.
25(3) Performs primary PCI as the treatment of first choice for
26STEMI, and has policies and procedures that require the tracking
27of door-to-balloon times, with a goal of 90 minutes or less, and
28requires that outlier cases be carefully reviewed for process
30(4) Permits only interventionists who meet the following
31requirements to perform elective PCI under the pilot program:
32(A) Perform at least 100 total PCI procedures per year, including
33at least 18 primary PCI per year.
34(B) Have lifetime experience of at least 500 total PCI procedures
35as primary operator.
36(C) Have complication rates and outcomes equivalent or superior
37to 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
7with training in interventional laboratories. Cardiac catheterization
begin delete mustend delete have demonstrated competency
9treating acutely ill patients with hemodynamic and electrical
11(6) Employs experienced intensive care unit nursing staff who
12have demonstrated competency with invasive hemodynamic
13monitoring, temporary pacemaker operation, and intraaortic balloon
14pump management. Nursing personnel
begin delete mustend delete be capable of
15managing endotracheal intubation and ventilator management both
16onsite and during transfer, if necessary. The eligible hospital shall
17demonstrate sufficient staffing capacity in the intensive care unit
18to provide posttreatment care for patients undergoing elective PCI.
19(7) Has a well-equipped and maintained cardiac catheterization
20laboratory with high resolution digital imaging capability and
21intraaortic balloon pump support compatible with transport
22vehicles. The ability for the real-time transfer of images and
23hemodynamic data via T-1 transmission line as well as audio and
24video images to review terminals for consultation at the receiving
25hospital is ideal.
26(8) Has an appropriate inventory of interventional equipment,
27including guide catheters, balloons, and stents in multiple sizes,
28throbectomy and distal protection devices, covered stents,
29temporary pacemakers, and pericardiocentesis trays. Pressure wire
30devices and intravascular ultrasound equipment are optimal, but
32(9) Provides evidence showing the full support from hospital
33administration in fulfilling the necessary institutional requirements,
34including, but not limited to, appropriate support services such as
35respiratory care and blood banking.
36(10) Has a written transfer agreement for the emergency transfer
37of patients to a facility with cardiac surgery services. Transport
38protocols shall be developed and tested a minimum of twice per
begin delete mustend delete ensure the immediate and efficient transfer
40of patients, within 60 minutes, 24 hours per day, seven days per
P5 1week, from the eligible hospital to the receiving hospital. The time
2for transfer of patients shall be calculated from the time it is
3determined that transfer of a patient for emergency cardiac surgery
4is necessary at the eligible hospital, to the time that the patient
5arrives at the receiving hospital.
6(11) Has onsite rigorous data collection, outcomes analysis,
7benchmarking, quality improvement, and formalized periodic case
9(12) Participates in the American College of
10Cardiology-National Cardiovascular Data Registry.
11(13) Provides evidence in its application
that demonstrates the
12use of rigorous case selection for patients undergoing elective PCI.
13Patient selection criteria will meet all of the following
14requirements, or otherwise be consistent with the recommendations
15of the SCAI, as those recommendations may evolve.
16(A) Patient selection shall be based on the interventionalist’s
17professional medical judgment, which may include, but is not
18limited to, consideration of the patient’s risk, the patient’s lesion
19risk, and the patient’s overall health status.
20(B) For purposes of this section, “patient risk” means the
21expected clinical risk in case of occlusion or other serious
22complication caused by the procedure. “High patient risk” may
23include, but is not limited to, patients with any of the following
24features: decompensated congestive heart failure (Killip class III)
25without evidence for active ischemia, recent cardiovascular attack,
26advanced malignancy, or known clotting disorders; left ventricular
27ejection fraction less than or equal to 25 percent; left main stenosis
28greater than or equal to 50 percent or three-vessel disease
29unprotected by prior bypass surgery greater than 70 percent stenosis
30in the proximal segment of all major epicardial coronary arteries;
31or a single target lesion that jeopardizes over 50 percent of
32remaining viable myocardium.
33(C) For purposes of this section, “lesion risk” means the
34probability that the procedure will cause acute vessel occlusion or
35other serious complication. “High lesion risk” may include, but is
36not limited to, lesions in open vessels with any of the following
37characteristics: diffuse disease (greater than
begin delete 2 cmend delete
38 in length) and excessive tortuosity of proximal segments; more
39than moderate calcification of a stenosis or proximal segments;
40location in an extremely angulated segment (greater than 90
P6 1percent); inability to protect major side branches; degenerated
2older vein grafts with friable lesions; substantial thrombus in the
3vessel or at the lesion site; and any other feature that may, in the
4interventionalist’s judgment, impede stent deployment.
5(D) In evaluating patient risk and lesion risk to determine patient
6eligibility for inclusion in the pilot program, the interventionalist
7shall apply the strategy set forth by the SCAI as set forth below,
8or as it may otherwise evolve:
9(i) A high-risk patient with a high-risk lesion shall not be
10 included in the pilot program.
11(ii) A high-risk patient with a not high-risk lesion may be
12included in the pilot program upon confirmation that a cardiac
13surgeon and an operating room are immediately available if
15(iii) A not high-risk patient with a high-risk lesion may be
16included in the pilot program.
17(iv) A not high-risk patient with a not high-risk lesion may be
18included in the pilot program.
19(14) Will include evidence of institutional review board (IRB)
20approval of its participation in the pilot program for as long as
21ACC/AHA/SCAI guidelines categorize elective PCI with offsite
22cardiac surgery as a Class III indication.
23(15) Shall demonstrate evidence of the process for obtaining
24written informed consent from patients prior to undergoing elective
25PCI. The application shall include a copy of the eligible hospital’s
26informed consent form applicable to elective PCI. Evidence of
27IRB approval of the informed consent form will also be provided
28for as long as ACC/AHA/SCAI guidelines categorize elective PCI
29with offsite cardiac surgery a Class III indication.
30(d) Consistent with this section, the department shall invite
31eligible hospitals to submit an application to participate in the
32Elective PCI Pilot Program. The applications shall include
33sufficient information to demonstrate compliance with the
34standards set forth in this section, and additionally include the
35effective date for initiating elective PCI service, the general service
36area, a description of the population to be served, a description of
37the services to be provided, a description of backup emergency
38services, the availability of comprehensive care, and the
39qualifications of the general acute care hospital providing the
40emergency treatment. The department may require that additional
P7 1information be submitted with the application. Failure to include
2any required criteria or additional information shall disqualify the
3applicant from the application process and from consideration for
4participation in the pilot program. The department may select up
5to six general acute care hospitals for participation in the Elective
6PCI Pilot Program based on the applicant’s ability to meet or
7exceed the criteria described in this section.
8(e) An advisory oversight committee comprised of one
9interventionalist from each pilot hospital, an equal number of
10cardiologists from nonpilot hospitals, and a representative of the
11department shall be created to oversee, monitor, and make
12recommendations to the department concerning the pilot program.
13In designating the cardiologists from nonpilot hospitals to the
14committee, the department shall consider the recommendations of
15the California Chapter of the American College of Cardiology.
16The advisory oversight committee shall submit at least two reports
17to the department during the pilot period. The oversight committee
18shall conduct a final report by
begin delete July 31, 2013,end delete
19 including recommendations for the continuation or termination of
20the pilot program.
21(f) If at any time a pilot hospital fails to meet the criteria set
22forth in this section for being a pilot hospital or fails to safeguard
23patient safety, as determined by the department, that pilot hospital
24shall be removed from participation in the pilot program by the
26(g) Each pilot hospital shall provide quarterly reports to the
27department and the oversight committee that include statistical
28data and patient information relating to the number of elective PCI
29procedures performed, the interventionalists performing elective
30PCI procedures, and the outcomes of those procedures. In addition,
31pilot hospitals shall include in the report recommendations, if any,
32for modifications to the pilot program and any other information
33the pilot hospitals deem relevant for evaluating the success of the
34pilot program in delivering improved patient care. The department
35and the oversight committee may make site visits to any pilot
36hospital at any time.
37(h) Notwithstanding Section 10231.5 of the
38within 90 days of receiving the final report of the oversight
39 committee, the department shall prepare and submit a report to the
40Legislature, pursuant to Section 9795 of the Government Code,
P8 1on the initial results of the Elective PCI Pilot Program. The report
2shall include, but not be limited to, an evaluation of the pilot
3program’s cost, safety, and quality of care. The report shall also
4include a comparison of elective PCI performed in connection
5with the Elective PCI Pilot Program, and elective PCI performed
6in hospitals with onsite cardiac surgery services. The report shall
7further recommend whether elective PCI without onsite cardiac
8surgery should be continued in California, and if so, under what
10(i) The department may charge pilot hospitals a supplemental
11licensing fee, the amount of which shall not exceed the cost to the
12department of overseeing the pilot program.
13(j) The department may contract with a professional entity with
14medical program knowledge to meet the requirements of this
16(k) This section shall remain in effect only until January 1, 2015,
17and as of that date is repealed, unless a later enacted statute, that
18is enacted before January 1, 2015, deletes or extends that date.
This act is an urgency statute necessary for the
20immediate preservation of the public peace, health, or safety within
21the meaning of Article IV of the Constitution and shall go into
22immediate effect. The facts constituting the necessity are:
23In order to ensure continued operation of a successful program
24that is saving lives, it is necessary that this act take effect