BILL NUMBER: SB 906 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JUNE 4, 2014
AMENDED IN SENATE APRIL 7, 2014
INTRODUCED BY Senator Correa
JANUARY 21, 2014
An act to add Section 1256.01 to the Health and Safety Code,
relating to health facilities.
LEGISLATIVE COUNSEL'S DIGEST
SB 906, as amended, Correa. Elective Percutaneous Coronary
Intervention (PCI) Offsite Program.
Existing law establishes, until January 1, 2015, 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 create the Elective Percutaneous Coronary
Intervention Offsite Program in the State Department of Public Health
to certify an unlimited number of general acute care hospitals that
are licensed to provide urgent and emergent cardiac
catheterization laboratory service in California, and that meet
prescribed, additional criteria, to perform scheduled, elective PCI.
The bill would authorize a hospital that was participating in the
Elective PCI Pilot Program as of December 31, 2014, to continue to
perform elective PCI provided that the hospital obtains a
certification under the bill's provisions by January 1, 2016. The
bill would require the Office of Statewide Health Planning and
Development to annually develop and make available to the public a
report regarding each participating hospital's performance on
mortality, stroke rate, and emergency coronary artery bypass graft
rate and would authorize the department to form an advisory oversight
committee for the purpose of analyzing those reports and
recommending changes to the data to be included in the reports. The
bill would also authorize the department to charge each participating
hospital a supplemental licensing fee not to exceed the reasonable
cost to the department of overseeing the program.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1256.01 is added to the Health and Safety Code,
to read:
1256.01. (a) The Elective Percutaneous Coronary Intervention
(PCI) Offsite 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) "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.
(2) "Eligible hospital" means a general acute care hospital that
has a licensed cardiac catheterization laboratory and is in
substantial compliance with all applicable state and federal
licensing laws and regulations.
(3) "Interventionalist" means a licensed cardiologist who meets
the requirements for performing elective PCI at an offsite hospital.
(4) "Offsite hospital" means a hospital participating in the
Elective Percutaneous Coronary Intervention (PCI) Offsite Program
established by this section.
(5) "Primary percutaneous coronary intervention (primary PCI)"
means percutaneous transluminal coronary angioplasty and stent
placement that is emergent in nature for acute myocardial infarction
and that is performed before administration of thrombolytic agents.
(c) To participate in the Elective PCI Offsite 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.
(d) An eligible hospital shall submit an application to the
department to obtain certification to participate in the Elective PCI
Offsite Program. The application shall include sufficient
information to demonstrate compliance with the standards set forth in
this section, and also 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 general acute care hospital providing the
emergency treatment. The department may require that additional
information be submitted with the application. Failure to
include submit any required criteria or
additional information shall disqualify the applicant from the
application process and from consideration for participation in the
program.
(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 an offsite hospital
provided that the hospital obtains a certification under this section
by January 1, 2016.
(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 offsite 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 offsite hospitals, two
interventionalists from general acute care hospitals that are not
offsite 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 an offsite hospital fails to meet the criteria
set forth in this section for being an offsite hospital or fails to
safeguard patient safety, as determined by the department, the
department shall may revoke the
certification issued to that offsite hospital under this section. An
offsite 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 offsite 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.