Cal. Code Regs. Tit. 22, § 71567 - Adverse Event Reporting Requirements
(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.
Notes
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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