California Code of Regulations
Title 22 - Social Security
Division 5 - Licensing and Certification of Health Facilities, Home Health Agencies, Clinics, and Referral Agencies
Chapter 1 - General Acute Care Hospitals
Article 11 - Adverse Event Reporting Requirements
Section 70972 - Adverse Event Reporting Requirements

Universal Citation: 22 CA Code of Regs 70972

Current through Register 2024 Notice Reg. No. 38, September 20, 2024

(a) Pursuant to Health and Safety Code sections 1279.1 and 1279.3, adverse events shall be reported by the hospital through a secure internet website maintained by the Department pursuant to the following timelines:

(1) Adverse events that are ongoing urgent or emergent, threatening the welfare, health, or safety of patients, personnel, or visitors, shall be reported within 24 hours after the adverse event is detected.

(2) Sexual assault of a patient, including allegations of sexual assault of a patient, provided for under Health and Safety Code section 1279.1(b)(6)(C), shall be reported within 24 hours after detection.

(3) All other adverse events shall be reported to the Department no later than five (5) calendar days after the adverse event is detected.

(b) When reporting adverse events, the hospital shall provide to the Department the following information:

(1) Name and address of the hospital.

(2) Location and service area where the adverse event occurred.

(3) Date and time the adverse event occurred and was detected, if known.

(4) Name of each individual affected by the adverse event and any patients, personnel, and visitors involved or a witness to the adverse event, if known.

(5) Description of the circumstances surrounding the adverse event, including the nature and extent of injury or harm.

(6) If an individual affected by the adverse event is a patient, the date the patient, or the party responsible for the patient, was informed of the adverse event. This date shall not be later than the date the hospital reported the adverse event to the Department.

(7) Name, title, area code, and telephone number of a hospital representative for the Department to contact for additional information.

(8) Hospital's immediate corrective or mitigating action in response to the adverse event.

(9) Any additional information as it becomes available regarding the adverse event.

(c) In the event the Department's secure internet website is not operational, the hospital shall report an adverse event to the Department by email or telephone.

1. New section filed 10-28-2021; operative 1-1-2022 (Register 2021, No. 44). Filing deadline specified in Government Code section 11349.3(a) extended 60 calendar days pursuant to Executive Order N-40-20 and an additional 60 calendar days pursuant to Executive Order N-71-20.

Note: Authority cited: Sections 1275, 131050, 131051, 131052 and 131200, Health and Safety Code. Reference: Sections 1279.1, 1279.2, 1279.3 and 1279.6, Health and Safety Code.

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