​This letter provides notification of the reporting requirements for adverse events pursuant to Health and Safety Code (HSC) Section 1279.1 and in addition, information regarding the investigation procedures mandated by HSC Section 1279.2.

Statutory Mandates

HSC § 1279.1 requires a General Acute Care Hospital (GACH), Acute Psychiatric Hospital (APH), or Special Hospital (SH) to report an adverse event to the department no later than five (5) days after the adverse event has been detected, or if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected.

The term "Adverse Event" is defined in HSC § 1279.1(b) and includes any one of 28 events (see attachment A).

HSC § 1279.2 (a)(1) requires that in any case in which the department receives a report of an adverse event from a GACH, APH, or a SH, or a written or oral complaint, as defined (HSC § 1279.2 (d)) involving a GACH, APH, or SH, that indicates an ongoing threat of imminent danger of death or serious bodily harm, the department shall make an onsite inspection or investigation within 48 hours or two business days, whichever is greater, of the receipt of the report or complaint and shall complete that investigation within 45 days

Further, HSC § 1279.2(b) requires that in any case in which the department is able to determine from the information available to it that there is no threat of imminent danger of death or serious bodily harm to that patient or other patients, the department shall complete an investigation of the report within 45 days.

Reporting and Investigation Background

Consequent to HSC § 1279.2 (a)(1) and HSC § 1279.2 (b), the department relies on specific information in order to determine and adhere to the most appropriate investigation deadline.

In the recent past, many hospitals have taken to reporting adverse events using a letter template that utilizes check boxes, each indicating one of the 28 adverse event categories. The familiarity produced by the use of a commonly used template is helpful to the department and allows for prompt recognition of reported information, and although it is not required, it is valued.

With such frequent use of a common template, the department has been able to identify common errors of inaccurate reporting and additional information that would assist in determining the most appropriate investigative response.

HSC § 1279.1 (b) (7) describes an adverse event to include: "An adverse event or series of adverse events that cause the death or serious disability of a patient, personnel, or visitor." The department has received a significant number of reported events for this category that do not actually meet the criteria. Correct use of this category will ensure the most accurate reporting. The department encourages GACHs, APHs, and SHs to consult the complete list of adverse events, (HSC § 1279.1(b); provided in this document as Attachment A) prior to categorizing the event for reporting purposes.

Usually, upon receipt of a report submitted by a GACH, APH, or SH, the department must make contact with the reporting facility to gather additional information to determine if the reported adverse event meets the criteria described in

HSC § 1279.2 (a) (1), requiring on-site inspection within 48 hours or two business days.

While not an exhaustive list, the department has identified the following information as beneficial to making such determinations:

• Hospital/Facility name
• Location of facility; Address and City
• Contact person; including name, telephone number and fax number
• Date adverse event occurred or date detected
• Date the adverse event is being reported
• Identification of adverse event category
• A brief description of the event (for events categorized under 1279.1 (b)(7))

Objectives

As the department and reporting hospitals gain more experience with, and knowledge of, the statutes and implementation process, procedures can be streamlined to enhance and expedite the accurate reporting of adverse events. In addition, report accuracy will provide the department greater ability to track reported events, both substantiated and unsubstantiated, consistently across the state. The department has begun efforts to reclassify unsubstantiated reported events as "Entity Reported Incidents" rather than as an adverse event, as determined by the investigation. This modification will allow departmental reports to reflect the most accurate information possible concerning adverse events and their dispositions.

A review of the number of adverse events by individual hospitals indicates that there may be some level of underreporting of adverse events (based on the size of the hospital versus number of adverse events reported or the absence of any adverse event reported since the implementation of this reporting requirement). We encourage all hospital providers to regularly review the reporting mandates of SB 1301 with all appropriate hospital staff to ensure that your facility is meetings its statutory obligation.

The department invites reporting facilities (GACHs, APHs, and SHs) to provide assistance in improving the accuracy of adverse event reporting. As such, the department would value hospitals' consideration of providing the additional information previously described when hospitals report the occurrence and detection of an adverse event. By providing the requested specific information, reporting facilities will assist the department to conduct the required investigations with the least disruption to facility operations.

If you have any questions about the reporting of adverse events or classification categories, please do not hesitate to contact your local district office.

Sincerely,

Original Signed by Pamela Dickfoss for Kathleen Billingsley, R.N.

Kathleen Billingsley, R.N.

Deputy Director

Center for Health Care Quality

Health and Safety Code 1279.1