Section 1256.01 Of Article 1. General From California Health And Safety Code >> Division 2. >> Chapter 2. >> Article 1.
1256.01
. (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.