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 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
14SCAI for performance of PCI without onsite cardiac surgery, as
15those recommendations may evolve over time, and meets all of
16the following criteria:
17(1) Performs at least 36 primary PCI procedures annually, has
18the capacity to perform at least 200 primary and elective PCI
19procedures annually, and by year two of participation in the pilot
20program, actually performs at least 200 primary and elective
21procedures, including at least 36 primary PCI procedures.
22(2) Has an on-call schedule with operation of the cardiac
23catheterization laboratory 24 hours per day, 365 days per year.
24(3) Performs primary PCI as the treatment of first choice for
25STEMI, and has policies and procedures that require the tracking
26of door-to-balloon times, with a goal of 90 minutes or less, and
27requires that outlier cases be carefully reviewed for process
29(4) Permits only interventionists who meet the following
30requirements to perform elective PCI under the pilot program:
31(A) Perform at least 100 total PCI procedures per year, including
32at least 18 primary PCI per year.
33(B) Have lifetime experience of at least 500 total PCI procedures
34as primary operator.
35(C) Have complication rates and outcomes equivalent or superior
36to national benchmarks established by the American College of
38(D) Hold board certification by the American Board of Internal
39Medicine in Interventional Cardiology and Cardiovascular
P4 1(E) Actively participate in the eligible hospital’s quality
3(5) Employs experienced nursing and technical laboratory staff
4with training in interventional laboratories. Cardiac catheterization
5laboratory personnel must have demonstrated competency treating
6acutely ill patients with hemodynamic and electrical instability.
7(6) Employs experienced intensive care unit nursing staff who
8have demonstrated competency with invasive hemodynamic
9monitoring, temporary pacemaker operation, and intraaortic balloon
10pump management. Nursing personnel must be capable of
11managing endotracheal intubation and ventilator management both
12onsite and during transfer, if necessary. The eligible hospital shall
13demonstrate sufficient staffing capacity in the intensive care unit
14to provide posttreatment care for patients undergoing elective PCI.
15(7) Has a well-equipped and maintained cardiac catheterization
16laboratory with high resolution digital imaging capability and
17intraaortic balloon pump support compatible with transport
18vehicles. The ability for the real-time transfer of images and
19hemodynamic data via T-1 transmission line as well as audio and
20video images to review terminals for consultation at the receiving
21hospital is ideal.
22(8) Has an appropriate inventory of interventional equipment,
23including guide catheters, balloons, and stents in multiple sizes,
24throbectomy and distal protection devices, covered stents,
25temporary pacemakers, and pericardiocentesis trays. Pressure wire
26devices and intravascular ultrasound equipment are optimal, but
evidence showing the full support from hospital
29administration in fulfilling the necessary institutional requirements,
30including, but not limited to, appropriate support services such as
31respiratory care and blood banking.
32(10) Has a written transfer agreement for the emergency transfer
33of patients to a facility with cardiac surgery services. Transport
34protocols shall be developed and tested a minimum of twice per
35year, and must ensure the immediate and efficient transfer of
36patients, within 60 minutes, 24 hours per day, seven days per week,
37from the eligible hospital to the receiving hospital. The time for
38transfer of patients shall be calculated from the time it is
39determined that transfer of a patient for emergency cardiac surgery
P5 1is necessary at the eligible hospital, to the time that the patient
2arrives at the receiving hospital.
3(11) Has onsite rigorous data collection,
4benchmarking, quality improvement, and formalized periodic case
6(12) Participates in the American College of
7Cardiology-National Cardiovascular Data Registry.
8(13) Provides evidence in its application that demonstrates the
9use of rigorous case selection for patients undergoing elective PCI.
10Patient selection criteria will meet all of the following
11requirements, or otherwise be consistent with the recommendations
12of the SCAI, as those recommendations may evolve.
13(A) Patient selection shall be based on the interventionalist’s
14professional medical judgment, which may include, but is not
15limited to, consideration of the patient’s risk, the patient’s lesion
16risk, and the patient’s overall health status.
17(B) For purposes of this
section, “patient risk” means the
18expected clinical risk in case of occlusion or other serious
19complication caused by the procedure. “High patient risk” may
20include, but is not limited to, patients with any of the following
21features: decompensated congestive heart failure (Killip class 3)
22without evidence for active ischemia, recent cardiovascular attack,
23advanced malignancy, known clotting disorders; left ventricular
24ejection fraction less than or equal to 25 percent; left main stenosis
25greater than or equal to 50 percent or three-vessel disease
26unprotected by prior bypass surgery greater than 70 percent stenosis
27in the proximal segment of all major epicardial coronary arteries;
28single target lesion that jeopardizes over 50 percent of remaining
30(C) For purposes of this section, “lesion risk” means the
31probability that the procedure will cause acute vessel occlusion or
32other serious complication. “High lesion risk” may include, but is
33not limited to, lesions in open vessels with any of the following
34characteristics: diffuse disease (greater than 2 cm in length) and
35excessive tortuoisty of proximal segments; more than moderate
36calcification of a stenosis or proximal segments; location in an
37extremely angulated segment (greater than 90 percent); inability
38to protect major side branches; degenerated older vein grafts with
39friable lesions; substantial thrombus in the vessel or at the lesion
P6 1site; and any other feature that may, in the interventionalist’s
2judgment, impede stent deployment.
3(D) In evaluating patient risk and lesion risk to determine patient
4eligibility for inclusion in the pilot program, the interventionalist
5shall apply the strategy set forth by the SCAI as set forth below,
6or as it may otherwise evolve:
7(i) A high-risk patient with a high-risk lesion shall not be
8included in the pilot program.
9(ii) A high-risk patient with a not high-risk lesion may be
10included in the pilot program upon confirmation that a cardiac
11surgeon and an operating room are immediately available if
13(iii) A not high-risk patient with a high-risk lesion may be
14included in the pilot program.
15(iv) A not high-risk patient with a not high-risk lesion may be
16included in the pilot program.
17(14) Will include evidence of institutional review board (IRB)
18approval of its participation in the pilot program for as long as
19ACC/AHA/SCAI guidelines categorize elective PCI with offsite
20cardiac surgery as a Class III indication.
21(15) Shall demonstrate evidence of the process for obtaining
22written informed consent from patients prior to undergoing elective
23PCI. The application shall include a copy of the eligible hospital’s
24informed consent form applicable to elective PCI. Evidence of
25IRB approval of the informed consent form will also be provided
26for as long as ACC/AHA/SCAI guidelines categorize elective PCI
27with offsite cardiac surgery a Class III indication.
28(d) Consistent with this section, the department shall invite
29eligible hospitals to submit an application to participate in the
30Elective PCI Pilot Program. The applications shall include
31sufficient information to demonstrate compliance with the
32standards set forth in this section, and additionally include the
33effective date for initiating elective PCI service, the general service
34area, a description of the population to be served, a description of
35the services to be provided, a description of backup emergency
36services, the availability of comprehensive care, and the
37qualifications of the general acute care hospital providing the
38emergency treatment. The department may require that additional
39information be submitted with the application. Failure to include
40any required criteria or additional information shall disqualify the
P7 1applicant from the application process and from consideration for
2participation in the pilot program. The department may select up
3to six general acute care hospitals for participation in the Elective
4PCI Pilot Program based on the applicant’s ability to meet or
5exceed the criteria described in this section.
6(e) An advisory oversight committee comprised of one
7interventionalist from each pilot hospital, an equal number of
8cardiologists from nonpilot hospitals, and a representative of the
9department shall be created to oversee, monitor, and make
10recommendations to the department concerning the pilot program.
11In designating the cardiologists from nonpilot hospitals to the
12committee, the department shall consider the recommendations of
13the California Chapter of the American College of Cardiology.
14The advisory oversight committee shall submit at least two reports
15to the department during the pilot period. The oversight committee
16shall conduct a final report
begin delete at the conclusion of the pilot programend delete
17, including recommendations for the continuation
18or termination of the pilot program.
19(f) If at any time a pilot hospital fails to meet the criteria set
20forth in this section for being a pilot hospital or fails to safeguard
21patient safety, as determined by the department, that pilot hospital
22shall be removed from participation in the pilot program by the
24(g) Each pilot
hospital shall provide quarterly reports to the
25department and the oversight committee that include statistical
26data and patient information relating to the number of elective PCI
27procedures performed, the interventionalists performing elective
28PCI procedures, and the outcomes of those procedures. In addition,
29pilot hospitals shall include in the report recommendations, if any,
30for modifications to the pilot program and any other information
31the pilot hospitals deem relevant for evaluating the success of the
32pilot program in delivering improved patient care. The department
33and the oversight committee may make site visits to any pilot
34hospital at any time.
begin deleteThe end deletedepartment shall prepare and submit a report to the
39 on the results of the Elective PCI Pilot Program. The
begin delete report
40shall be submitted no later than 90 days after termination ofend delete
P8 1 the pilot program. The report shall include, but not be
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) This section shall remain in effect only until January 1, 2014,
18allowing up to two years for implementation and at least three
19years during which the pilot program will be operational. As of
20January 1, 2014, this section is repealed, unless a later enacted
21statute, that is enacted before January 1, 2014, deletes or extends
This act is an urgency statute necessary for the
27immediate preservation of the public peace, health, or safety within
28the meaning of Article IV of the Constitution and shall go into
29immediate effect. The facts constituting the necessity are:
30In order to ensure continued operation of a successful program
31that is saving lives, it is necessary that this act take effect