(a) The building standards published in the California Building Standards Code by the Department of Health Care Access and Information, and the regulations adopted by the State Department of Public Health shall, as applicable, prescribe standards of adequacy, safety, and sanitation of the physical plant, of staffing with duly qualified licensed personnel, and of services, based on the type of health facility and the needs of the persons served thereby.
(b) These regulations shall permit program flexibility by the use of alternate concepts, methods, procedures, techniques, equipment, personnel qualifications, bulk purchasing of pharmaceuticals, or conducting of pilot projects as long as statutory requirements are met and the use has the prior written approval of the State Department of Public Health or the Department of Health Care Access and Information, as applicable. The approval of the department or the Department of Health Care Access and Information shall provide for the terms and conditions under which the exception is granted. A written request plus supporting evidence shall be submitted by the applicant or licensee to the department or Department of Health Care Access and Information regarding the exception, as applicable.
(c) While it is the intent of the Legislature that health facilities shall maintain continuous, ongoing compliance with the licensing rules and regulations, it is the further intent of the Legislature that the State Department of Public Health expeditiously review and approve, if appropriate, applications for program flexibility. The Legislature recognizes that health care technology, practice, pharmaceutical procurement systems, and personnel qualifications and availability are changing rapidly. Therefore, requests for program flexibility require expeditious consideration.
(d) The department shall, on or before April 1, 1989, develop a standardized form and format for requests by health facilities for program flexibility. Health facilities shall thereafter apply to the department for program flexibility in the prescribed manner. After the department receives a complete application requesting program flexibility, it shall have 60 days within which to approve, approve with conditions or modifications, or deny the application. Denials and approvals with conditions or modifications shall be accompanied by an analysis and a detailed justification for any conditions or modifications imposed. Summary denials to meet the 60-day timeframe shall not be permitted.
(e) To the extent that an application by a health facility for program flexibility, or for an extension of program flexibility, includes a request to allow the health facility to designate a bed or multiple beds in a critical care unit as requiring a lower level of care, including, but not limited to, the level of care provided in an intermediate care, step-down, telemetry, medical-surgical, specialty care, or pediatric services unit, that application shall be referred to as a “critical care unit program flexibility request.” This subdivision and subdivision (f) do not confer on the department any new or additional authority to modify staffing ratios.
(f) (1) The department shall require, as support for a critical care unit program flexibility request, the applicant or licensee to submit supporting evidence that includes documentation establishing the need for program flexibility and that the proposed alternative will not jeopardize the health, safety, and well-being of patients and is needed for increased operational efficiency.
(A) Any critical care unit program flexibility request, including supporting evidence submitted with the request, shall be posted on the department’s publicly accessible internet website within five calendar days of receipt by the department.
(B) The department, at the time it posts a health facility’s critical care unit program flexibility request, shall provide a method to electronically collect public comment specifically on the application for a period of 30 days.
(C) The 60-day timeframe provided for in subdivision (d) shall not commence until a facility’s critical care unit program flexibility request and supporting evidence have been posted on the department’s internet website.
(2) (A) A health facility that makes a critical care unit program flexibility request shall comply with both of the following requirements:
(i) Conspicuously post the critical care unit program flexibility request form and a notice next to its license stating that a critical care unit program flexibility request and supporting evidence have been submitted to the department.
(ii) Immediately make its best effort to notify affected employees and employee representatives of the critical care unit program flexibility request and direction to where to find the request and supporting evidence, and where to provide public comment.
(B) A facility’s critical care unit program flexibility request will not be deemed complete for purposes of the 60-day timeframe pursuant to subdivision (d) until the facility has complied with this paragraph.
(3) In no event shall the department approve a health facility’s critical care unit program flexibility request for a period of more than one year.
(4) Any approval of a health facility’s critical care unit program flexibility request may be revoked by the department at any time, including on the grounds that there is no longer a need for program flexibility, that the approved alternative jeopardizes the health, safety, and well-being of patients, or that the approved alternative does not adequately protect patient safety.
(5) (A) The 30-day comment period required by subparagraph (B) of paragraph (1) shall not apply when a hospital submits a critical care unit program flexibility request due to a health care emergency. Critical care unit program flexibility requests approved pursuant to this paragraph shall not be effective for more than 90 days, and any request to extend the term of critical care unit program flexibility that was approved pursuant to this paragraph shall be subject to the regular process provided for in this subdivision.
(B) For purposes of this paragraph, “health care emergency” means an unpredictable or unavoidable occurrence at unscheduled or unpredictable intervals relating to health care delivery requiring immediate medical interventions and care.
(6) This subdivision shall become operative on January 1, 2023.
(g) Notwithstanding any other law or regulation, the State Department of Public Health shall provide flexibility in its pharmaceutical services requirements to permit any state department that operates state facilities subject to these provisions to establish a single statewide formulary or to procure pharmaceuticals through a departmentwide or multidepartment bulk purchasing arrangement. It is the intent of the Legislature that consolidation of these activities be permitted in order to allow the more cost-effective use and procurement of pharmaceuticals for the benefit of patients and residents of state facilities.
(h) On or before February 1, 2023, the department shall post all of the following information on its internet website:
(1) A list of applicants for critical care unit program flexibility and the date of the application.
(2) A list of health facilities with approved critical care unit program flexibility and the effective start and end date of the approval.
(3) If approved, the notification of approval for critical care unit program flexibility, which shall include the application for critical care unit program flexibility; the regulation or regulations impacted; beds, units, or departments affected; and any conditions placed on the approval.
(4) A department contact for the public to submit a complaint related to an approved critical care unit program flexibility.
(Amended by Stats. 2021, Ch. 716, Sec. 1. (AB 1422) Effective January 1, 2022.)