SECTIONS 100921-100922 - California Statutes

HEALTH AND SAFETY CODE

SECTION 100921-100922

100921. The Legislature finds and declares that:
(a) A pilot program was established by the Office of Statewide
Health Planning and Development to test the feasibility of performing
high quality, safe diagnostic cardiac catheterization procedures in
a freestanding cardiac catheterization laboratory.
(b) Evaluation of this pilot program by the office demonstrated
that it is feasible to conduct these procedures in nonhospital
settings and that these laboratories maintain the quality of the
diagnostic procedures while also reducing the cost of care.
(c) Based on this evaluation, it is the intent of the Legislature
that those freestanding cardiac catheterization laboratories that are
in active status in the pilot program be licensed.

100922. (a) Notwithstanding any other provision of law, a
freestanding cardiac catheterization laboratory that as of December
31, 1993, was in active status in the Health Care Pilot Project
established pursuant to former Part 1.85 (commencing with Section
444) of Division 1, and that meets the requirements specified in this
section, may be licensed by the State Department of Public Health as
a freestanding cardiac catheterization laboratory. The license shall
be subject to suspension or revocation, or both, in accordance with
Article 5 (commencing with Section 1240) of Chapter 1 of Division 2.
An application for licensure or annual renewal shall be accompanied
by a Licensing and Certification Program fee set in accordance with
Section 1266.
(b) A laboratory granted a license pursuant to this section shall
be subject to the department's regulations that govern cardiac
catheterization laboratories operating in hospitals without
facilities for cardiac surgery, any similar regulations that may be
developed by the department specifically to govern freestanding
cardiac catheterization laboratories, and to the following
regulations: subdivisions (a) and (d) of Section 70129 of; paragraphs
(1), (2), (3), and (4) of subdivision (a) of, and subdivision (i) of
Section 70433 of; paragraphs (1), (3), (4), and (5) of subdivision
(a) of Section 70435 of; subparagraphs (A), (B), and (D) of paragraph
(1) of, and paragraphs (5) and (7) of, subdivision (b) of Section
70437 of; subdivision (a) of Section 70439 of; Sections 70841, 75021,
and 75022 of; subdivision (a) of Section 75023 of; Sections 75024,
75025, and 75026 of; subdivisions (a), (b), and (c) of Section 75027
of; subdivision (b) of Section 75029 of; Section 75030 of;
subdivision (b) of Section 75031 of; Sections 75034, 75035, 75037,
75039, 75045, and 75046 of; subdivision (a) of Section 75047 of; and
Sections 75050, 75051, 75052, 75053, 75054, 75055, 75057, 75059,
75060, 75061, 75062, 75063, 75064, 75065, 75066, 75071, and 75072 of;
Title 22 of the California Code of Regulations.
(c) A laboratory granted a license pursuant to this section shall
have a system for the ongoing evaluation of its operations and the
services it provides. This system shall include a written plan for
evaluating the efficiency and effectiveness of the health care
services provided that describes the following:
(1) The scope of the services provided.
(2) Measurement indicators regarding the processes and outcomes of
the services provided.
(3) The assignment of responsibility when the data from the
measurement indicators demonstrates the need for action.
(4) A mechanism to ensure followup evaluation of the effectiveness
of the actions taken.
(5) An annual evaluation of the plan.
(d) A laboratory granted a license pursuant to this section is
authorized to perform only the following diagnostic procedures:
(1) Right heart catheterization or angiography, or both.
(2) Left heart catheterization or angiography, or both.
(3) Coronary catheterization and angiography.
(4) Electrophysiology studies.
(e) A laboratory granted a license pursuant to this section shall
only perform its procedures on adults, on an outpatient basis. Each
laboratory shall define patient characteristics that are appropriate
for safe performance of procedures in the laboratory, and include
evaluation of these criteria in its quality assurance process.
(f) Notwithstanding the requirements already set forth in this
chapter, freestanding cardiac catheterization laboratories shall
comply with all other applicable federal, state, and local laws.
(g) This section shall become operative on January 1, 1995, and
does not require the department to adopt regulations.