SECTIONS 100921-100922

100921.  The Legislature finds and declares that: (a) A pilot program was established by the Office of StatewideHealth Planning and Development to test the feasibility of performinghigh quality, safe diagnostic cardiac catheterization procedures ina freestanding cardiac catheterization laboratory. (b) Evaluation of this pilot program by the office demonstratedthat it is feasible to conduct these procedures in nonhospitalsettings and that these laboratories maintain the quality of thediagnostic procedures while also reducing the cost of care. (c) Based on this evaluation, it is the intent of the Legislaturethat those freestanding cardiac catheterization laboratories that arein active status in the pilot program be licensed.100922.  (a) Notwithstanding any other provision of law, afreestanding cardiac catheterization laboratory that as of December31, 1993, was in active status in the Health Care Pilot Projectestablished pursuant to former Part 1.85 (commencing with Section444) of Division 1, and that meets the requirements specified in thissection, may be licensed by the State Department of Public Health asa freestanding cardiac catheterization laboratory. The license shallbe subject to suspension or revocation, or both, in accordance withArticle 5 (commencing with Section 1240) of Chapter 1 of Division 2.An application for licensure or annual renewal shall be accompaniedby a Licensing and Certification Program fee set in accordance withSection 1266. (b) A laboratory granted a license pursuant to this section shallbe subject to the department's regulations that govern cardiaccatheterization laboratories operating in hospitals withoutfacilities for cardiac surgery, any similar regulations that may bedeveloped by the department specifically to govern freestandingcardiac catheterization laboratories, and to the followingregulations: subdivisions (a) and (d) of Section 70129 of; paragraphs(1), (2), (3), and (4) of subdivision (a) of, and subdivision (i) ofSection 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 Section70437 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 75027of; 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; andSections 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 shallhave a system for the ongoing evaluation of its operations and theservices it provides. This system shall include a written plan forevaluating the efficiency and effectiveness of the health careservices provided that describes the following: (1) The scope of the services provided. (2) Measurement indicators regarding the processes and outcomes ofthe services provided. (3) The assignment of responsibility when the data from themeasurement indicators demonstrates the need for action. (4) A mechanism to ensure followup evaluation of the effectivenessof the actions taken. (5) An annual evaluation of the plan. (d) A laboratory granted a license pursuant to this section isauthorized 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 shallonly perform its procedures on adults, on an outpatient basis. Eachlaboratory shall define patient characteristics that are appropriatefor safe performance of procedures in the laboratory, and includeevaluation of these criteria in its quality assurance process. (f) Notwithstanding the requirements already set forth in thischapter, freestanding cardiac catheterization laboratories shallcomply with all other applicable federal, state, and local laws. (g) This section shall become operative on January 1, 1995, anddoes not require the department to adopt regulations.