Bringing transparency to federal inspections
Tag No.: A0286
Based on record review and interview for one (Patient #1) of ten medical records reviewed. It was determined the Hospital failed to identify and address the lack of timeliness to report a medication incident in the online Safety Reporting System, according to Hospital polices and procedures.
Federal hospital regulations require that clear expectations for safety are established to measure, analyze and track medical errors and adverse events.
Findings include:
The Hospital's policy and procedure regarding Medication Management: Adverse Drug Events (ARDs), dated 8/15/19, indicated the Hospital's expectation to document a medication event in the Electronic Safety Reporting System. The ADRs are to be reported by any colleague of the Hospital in the online Safety Reporting System to provide an effective method for timely and meaningful reporting and follow-up of events.
The Hospital's policy and procedure regarding Safety Reports, dated 12/5/19, indicated the reporter must immediate notify the Director of Risk Management and or the Administrative Supervisor/On call risk management or legal services.
Review of the Safety Report regarding the metoprolol indicated the Safety Report was entered on 1/12/21, three days after Patient #1 received metoprolol 50 milligrams (mg) (aids in controlling heart rate), instead of the intended dose of 12.5 mg. As a result Patient #1 received 4 times the intended dose. Patient #1 became nauseated, diaphoretic, hypotensive and unresponsive. Cardiopulmonary resuscitation was initiated with a return of spontaneous circulation. Patient #1 was transferred to the Coronary Intensive Care Unit for further evaluation and care.
In an interview with Risk Manager #1 on 4/12/21 at 11:15 A.M., Risk Manager #1 said the cardiologist called her on 1/12/21 and reported the medication incident. Risk Manager #1 said she then entered the Safety Report, three days after the event. Risk Manager #1 said she thought the report was entered timely.