(a)For purposes of this section and Section 1256.06, the following definitions apply:
(1)“Critical access hospital” means a hospital designated by the State Department of Public Health as a critical access hospital, and certified as such by the Secretary of the United States Department of Health and Human Services under the federal Medicare Rural Hospital Flexibility Program.
(2)“Department” means the State Department of Public Health, unless otherwise specified.
(3)“Standardized order sets” means predefined groups of orders that support clinical decisions, including, but not limited to, appropriate treatments,
medications, and dosages, for specific conditions or procedures and that are developed using relevant evidence-based guidelines.
(4)“Standby perinatal services” means the
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(a)
For purposes of this section and Section 1256.06, the following definitions apply:
(1)
“Critical access hospital” means a hospital designated by the State Department of Public Health as a critical access hospital, and certified as such by the Secretary of the United States Department of Health and Human Services under the federal Medicare Rural Hospital Flexibility Program.
(2)
“Department” means the State Department of Public Health, unless otherwise specified.
(3)
“Standardized order sets” means predefined groups of orders that support clinical decisions, including, but not limited to, appropriate treatments,
medications, and dosages, for specific conditions or procedures and that are developed using relevant evidence-based guidelines.
(4)
“Standby perinatal services” means the provision of obstetric and neonatal medical care to patients who are transferred from an alternative birth center, or who present to the hospital’s emergency department with an urgent or emergent obstetric issue, in a specifically designated area of the hospital that is equipped and maintained at all times to receive patients and capable of providing physician, midwifery, and nursing services within a reasonable time not to exceed 30 minutes.
(b)
The department shall do all of the following:
(1)
By July 1, 2026, establish a 10-year pilot project within up to five critical access hospitals to allow participating hospitals to establish standby
perinatal services. If qualified, the first two hospitals selected shall be nonprofit and located in the County of Humboldt and the County of Plumas. Up to three additional critical access hospitals may be selected at any time if the application includes a signed agreement from the exclusive employee representatives of the workforce that the proposed pilot project site would not adversely impact the workforce or includes an attestation that there is no existing exclusive employee representative.
(2)
Within a reasonable time, determine whether hospitals requesting to participate meet applicable statutory requirements, including, but not limited to, all of the following:
(A)
Ability to meet the standards of the standby perinatal service, as described in Section 1256.06.
(B)
Provide surgery and anesthesia as basic
services of the hospital.
(C)
Maintain capability for obtaining or performing timely blood gas, pH, and microbiologic analyses.
(D)
Provide ability to maintain premixed infusions.
(E)
Maintain a basic emergency medical service, comprehensive emergency medical service, or standby emergency medical service licensed as a supplemental service.
(F)
(i)
Have a designated room or rooms for the standby perinatal service space. A hospital may designate an existing room or rooms with a licensed general acute care bed as the standby perinatal service space. If a hospital designates an existing room or rooms for the standby perinatal service space, the hospital may continue to provide general acute care services in that room or rooms when the
room or rooms are not in use by the standby perinatal services only if all remaining general acute care beds are occupied or a plan for management of perinatal patients using alternate space is approved by the department.
(ii)
The operating room may serve as the delivery room in hospitals having a licensed bed capacity of 25 or less, but the operating room shall not serve as the sole standby perinatal service space.
(G)
In consultation with stakeholders, establish any additional requirements that the department deems necessary to protect patient safety or to ensure quality of care under the pilot project.
(3)
(A)
Develop a template to collect and evaluate data on safety, outcomes, utilization, and populations served under the pilot project using stratified demographic data, to the extent
statistically reliable data are available and comply with medical privacy laws and practices. The department may, in consultation with relevant stakeholders, establish additional requirements for participating hospitals to collect and report any additional data under the pilot project that the department deems necessary.
(B)
Compile the data collected pursuant to subparagraph (A), prepare and submit an evaluation to the Legislature, and make the evaluation publicly available. The department shall submit the evaluation to the Legislature on or before two years after the completion of the pilot project. Data-collection requests shall be provided in a timely manner to enable the pilot hospital to collect and report the data before the deadline. The evaluation to be submitted to the Legislature pursuant to this subparagraph shall be submitted in compliance with Section 9795 of the Government Code.
(4)
Consult with relevant state departments and stakeholders on the matter of meeting the requirements of this subdivision. Stakeholders shall include representatives of hospitals, consumers, the American College of Obstetricians and Gynecologists, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Nurse-Midwives, health plans, labor, and other health care professionals who provide pediatric and pregnancy-related services, including, but not limited to, registered nurses, certified nurse-midwives, and licensed midwives.
(c)
A hospital seeking to participate in the pilot project shall submit an application to the department.
(d)
An approved standby perinatal service shall be subject to all relevant licensing enforcement provisions as established under this chapter and Chapter 1 (commencing with Section 70001) of
Division 5 of Title 22 of the California Code of Regulations.
(e)
If, at any time, a hospital with a standby perinatal service fails to meet the requirements set forth in this section or Section 1256.06, or fails to ensure patient health and safety, as determined by the department, the department may suspend or revoke its approval of the hospital’s participation in the pilot project.
(f)
(1)
Notwithstanding any other law or regulation, a hospital participating in the pilot project may, in consultation with the medical and any other relevant staff, request program flexibility for the statutory requirements of this section or Section 1256.06, in order to meet the particular capacities and needs of the hospital and community.
(2)
If the department approves the request described in paragraph (1),
the department’s approval shall provide for the terms and conditions under which the program flexibility is granted.
(3)
To request program flexibility for the statutory requirements of this section or Section 1256.06, the hospital shall follow existing procedures established by the department for program flexibility requests pursuant to subdivision (b) of Section 1276.
(g)
Notwithstanding any other law, the department may, without taking any regulatory actions pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, implement, interpret, or make specific this section and Section 1256.06 by means of an All Facilities Letter (AFL) or similar instruction.