Freestanding Cardiac Catheterization Laboratories
Cal. HSC § 100922
California Statutes
(
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 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 of; paragraphs (1), (2), (3), and (4) of subdivision (
a) of, and subdivision (
i) of
Section of; paragraphs (1), (3), (4), and (5) of subdivision (
a) of
Section of; subparagraphs (A), (B), and (
D) of paragraph (1) of, and paragraphs (5) and (7) of, subdivision (
b) of
Section of; subdivision (
a) of
Section of; Sections 70841, 75021, and of; subdivision (
a) of
Section of; Sections 75024, 75025, and of; subdivisions (a), (b), and (
c) of
Section of; subdivision (
b) of
Section of;
Section of; subdivision (
b) of
Section of; Sections 75034, 75035, 75037, 75039, 75045, and of; subdivision (
a) of
Section of; and Sections 75050, 75051, 75052, 75053, 75054, 75055, 75057, 75059, 75060, 75061, 75062, 75063, 75064, 75065, 75066, 75071, and of; Title 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.