(a) The Elective Percutaneous Coronary Intervention (PCI) Program is hereby established in the department. The purpose of the program is to allow the department to certify general acute care hospitals that are licensed to provide urgent and emergent 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) “Certified hospital” means an eligible hospital that is certified by the department to participate in the Elective Percutaneous Coronary Intervention (PCI) Program established by this section.
(2) “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.
(3) “Eligible hospital” means a general acute care hospital that has an approved cardiac catheterization laboratory, does not have onsite cardiac surgery, and is in substantial compliance with all applicable state and federal licensing laws and regulations.
(4) “Interventionalist” means a licensed cardiologist who meets the requirements for performing elective PCI.
(c) To participate in the Elective PCI Program, an eligible hospital shall obtain certification from the department and shall meet all of the following requirements:
(1) Demonstrate that it complies with the recommendations of the Society for Cardiovascular Angiography and Interventions (SCAI), the American College of Cardiology Foundation, and the American Heart Association, for performance of PCI without onsite cardiac surgery, as those recommendations may evolve over time.
(2) Provide 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.
(3) Participate in, and provide timely submission of data to, the American College of Cardiology-National Cardiovascular Data Registry.
(4) Confer rights to transfer the data submitted pursuant to paragraph (3) to the Office of Statewide Health Planning and Development.
(5) Any additional requirements the department deems necessary to protect patient safety or ensure quality of care.
(d) An eligible hospital shall submit an application to the department pursuant to Section 1265 to obtain certification to participate in the Elective PCI Program. The application shall include sufficient information to demonstrate compliance with the standards set forth in this section, and shall also 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 eligible hospital. The department may require that additional information be submitted with the application. Failure to submit any required criteria or additional information shall disqualify the applicant from the application process and from consideration for participation in the program. The department may deny an Elective PCI Program applicant pursuant to Article 2 (commencing with Section 1265).
(e) An eligible hospital that, as of December 31, 2014, was participating in the Elective Percutaneous Coronary Intervention Pilot Program established under Chapter 295 of the Statutes of 2008, as amended by Chapter 202 of the Statutes of 2013, may continue to perform elective PCI and shall be considered a certified hospital until January 1, 2016. On and after January 1, 2016, a hospital described in this subdivision shall not be considered a certified hospital unless the hospital has obtained a certification under this section.
(f) The Office of Statewide Health Planning and Development shall, using the data transferred pursuant to paragraph (4) of subdivision (c), annually develop and make available to the public a report regarding each certified hospital’s performance on mortality, stroke rate, and emergency coronary artery bypass graft rate.
(g) The department may establish an advisory oversight committee composed of two interventionalists from certified hospitals, two interventionalists from general acute care hospitals that are not certified hospitals, and a representative of the department, for the purpose of analyzing the report issued under subdivision (f) and making recommendations for changing the data to be included in future reports issued under subdivision (f).
(h) If at any time a certified hospital fails to meet the criteria set forth in this section for being a certified hospital or fails to safeguard patient safety, as determined by the department, the department may suspend or revoke, pursuant to Section 70309 of Title 22 of the California Code of Regulations, the certification issued to that hospital under this section. A hospital whose certification is revoked pursuant to this subdivision may request an appeal with the department and is not precluded from reapplying for certification under this section.
(i) The department may charge certified hospitals a supplemental licensing fee, the amount of which shall not exceed the reasonable cost to the department of overseeing the program.
(j) The department may contract with a professional entity with medical program knowledge to meet the requirements of this section.
(Added by Stats. 2014, Ch. 368, Sec. 1. (SB 906) Effective January 1, 2015.)
Last modified: October 25, 2018