Other·July 14, 2023

The following reflects the findings of the California Department of Public Health during the investigation of complaint number CA00844353 Representing the Department, HFEN # 43321 State Citation (B) was written. 22 CCR § 72541. Unusual Occurrences. Occurrences such as epidemic outbreaks, poisonings, fires, major accidents, death from unnatural causes or other catastrophes and unusual occurrences which threaten the welfare, safety or health of patients, personnel or visitors shall be reported by the facility within 24 hours either by telephone (and confirmed in writing) or by telegraph to the local health officer and the Department. An incident report shall be retained on file by the facility for one year. The facility shall furnish such other pertinent information related to such occurrences as the local health officer or the Department may require. Every fire or explosion which occurs in or on the premises shall be reported within 24 hours to the local fire authority or in areas not having an organized fire service, to the State Fire Marshal. On 6/7/2023, the California Department of Public Health (CDPH) made an unannounced visit to the facility to investigate a complaint about resident death and residents’ rights. The facility failed to implement its policy on Unusual Occurrence Reporting by not notifying CDPH local district office of Resident 1’s unexpected death occurred on 12/13/2023 after receiving the Coronavirus Disease 2019 (COVID-19) booster vaccine. As a result, CDPH was not aware of Resident 1’s unexpected death and learned about from a different source. A review of Resident 1’s Admission Record indicated the facility admitted the resident on 10/29/2022 with diagnoses including chronic obstructive pulmonary disease (COPD, group of lung disease that block airflow and make it difficult to breathe), atrial fibrillation (irregular heartbeat), dementia (loss of cognitive functioning such as thinking, remembering, or reasoning to such extent that it interferes with a person’s daily life and activities), and myocardial infraction (heart attack). A review of Resident’1 s Minimum Data Set (MDS, a standardized assessment and care-screening tool), dated 11/3/2022, indicated Resident 1 was unable to remember and make decisions. Resident 1 needed limited assistance with bed mobility, transferring, walking, dressing, eating, toilet use and personal hygiene. A review of Resident 1’s Nursing Progress note, dated 12/13/2022 and timed at 12:30 pm, the Infection Preventionist Nurse 1 (IP 1) documented Resident 1 received the COVID-19 vaccine booster with no complaints of shortness of breath and stable vital signs. Resident 1 was observed for 15-20 minutes with no adverse reactions noted. Resident 1 was taken back to his room at 12:55 pm. At 1:24 pm, a Code Blue (is an announcement of a life-threatening medical emergency) was called, nursing staff called 911 (emergency telephone number to request emergency medical services) and the charge nurse initiated cardiopulmonary resuscitation (CPR, an emergency procedure used to restart a person's heartbeat and breathing after one or both have stopped). Paramedics arrived at 1:30 pm and continued to do CPR and at 2:02 pm paramedics pronounced Resident 1 dead. A review of the Physician’s Order for Resident 1, dated 12/13/2022, indicated to release Resident 1’s body to the mortuary. On 6/8/2023 at 4:20 pm, during an interview, the DON acknowledged the facility did not report to CDPH Resident 1’s death as an unusual occurrence but should have reported it since Resident 1’s death was not expected and happened soon after receiving the COVID-19 booster vaccine. The DON stated she could not recall and was unable to provide evidence Resident 1’s death was reported to VAERS (Vaccine Adverse Event Reporting System, a national vaccine safety monitoring system that accepts reports of true and suspected adverse events after vaccination). A review of the facility’s policy and procedures titled, “Unusual Occurrence Reporting,” revised 12/2007, indicated “As required by federal or state regulations, our facility reports unusual occurrences or other reportable events which affects the health, safety, or welfare of our residents, employees or visitors.” The policy indicated that the facility would report events such as a death of a resident, employee, or visitor because of unnatural causes (e.g., suicide, homicide, accidents, etc.). Unusual occurrences shall be reported via telephone to appropriate agencies as required by current law and/or regulations within twenty-four (24) hours of such incident or as otherwise required by federal and state regulations. A written report detailing the incident and actions taken by the facility after the event shall be sent or delivered to the state agency (and other appropriate agencies as required by law) within forty-eight (48) hours of reporting the event or as required by federal and state regulations and the administration will keep a copy of written reports on file. The facility failed to implement its policy on Unusual Occurrence Reporting by failing to notify CDPH local district office of Resident 1’s unexpected death occurred on 12/13/2023 after receiving the COVID-19 booster vaccine. As a result, CDPH was not aware of Resident 1’s unexpected death and learned about from a different source. The above violation had a direct relationship to the health, safety, and security of the residents in the facility.