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20900 BISCAYNE BLVD

AVENTURA, FL 33180

MEDICAL STAFF BYLAWS

Tag No.: A0353

Based on interview, record review and the Medical Staff Bylaws (approved October 19, 2017) the facility failed to provide quality care one (SP#1) out of 4 sample patients (SP), and fully implement the corrective action plan as a result of an adverse incident involving the physician.

Findings include:

Review of sample patient (SP) #1 medical record showed she presented to the emergency department on 10/11/2018 at 9:21 PM. The Lab work resulted at 10:53 PM with an INR (International Normalized Ratio) of 2.85. Patient was found to be hypertensive and was admitted. On 10/12/2018 at 6:01 AM patient is noted to have right sided weakness and facial droop and a stroke alert was initiated. CAT scan of the head and neck show abrupt cutoff of the left carotid terminus, highly probable this is acute. At 7:21 AM Alteplase is ordered by Physician A and a 9 mg intravenous bolus was administered by Staff J in the interventional radiology lab at 8:19 AM. MRI of brain at 3:52 PM showed a hemorrhage.

It was determined that Physician A inadvertently did not review the patient's lab results prior to ordering the Alteplase. Also the Registered Nurse Staff J administered the Alteplase without obtaining a two licensed verification co-signature. Corrective Action: Intensivists and Cath Lab/Interventional Radiology Registered Nurse will receive stroke certification and education to include thrombolytics.

Review of the Corrective Action Plan dated November 2018 revealed the plan was developed based on the findings on 10/19/2018. Topics identified include: Process deviation noted by the Critical Care Physician and also the Cath Lab Nurse. The Action plan did not include completion dates,.

Interview with Stroke Coordinator on 04/08/2019 at 12:05 PM confirmed audits for abnormal labs results prior to ordering the Alteplase were not completed to evaluate the compliance of the strategies/actions of the identified goals for the physicians.

Review of In-House Stroke Alert Altepase Administration Audit for only Physician A was provided on 04/09/2019 at 12:55 PM. The Audit revealed the identification of the Inclusion/Exclusion Criteria review and the Altepase administration ordered by Physician A for the period of 12/08/2018 to 03/30/2019. Physician A had no outliers. Sixty percent (60%) of the Critical Care Physicians/Residents completed, 2 Remaining Physicians for Stroke Alerts/1 Requires Validation of Competency.

The "Medical Staff Bylaws" (approved October 19, 2017), states the purposes and responsibilities of the Medical Staff are to provide patients with the quality of care that is commensurate with acceptable standards and available community resources.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interview, record review the facility failed to administer drugs in accordance to the accepted standards of practice in one (SP#1) out of 4 sample patients (SP) and fully implement the corrective action plan as a result of an adverse incident involving Cath Lab/Interventional Radiology Registered Nurse.

Findings include:

Review of sample patient (SP) #1 medical record showed she presented to the emergency department on 10/11/2018 at 9:21 PM. The Lab work resulted at 10:53 PM with an INR (International Normalized Ratio) of 2.85. Patient was found to be hypertensive and was admitted. On 10/12/2018 at 6:01 AM patient is noted to have right sided weakness and facial droop and a stroke alert was initiated. CAT scan of the head and neck show abrupt cutoff of the left carotid terminus, highly probable this is acute. At 7:21 AM Alteplase is ordered by Physician A and a 9 mg intravenous bolus was administered by Staff J in the interventional radiology lab at 8:19 AM. MRI of brain at 3:52 PM showed a hemorrhage.

It was determined that Physician A inadvertently did not review the patient's lab results prior to ordering the Alteplase. Also the Registered Nurse Staff J administered the Alteplase without obtaining a two licensed verification co-signature. Corrective Action: Intensivists and Cath Lab/Interventional Radiology Registered Nurse will receive stroke certification and education to include thrombolytics.

Review of the Corrective Action Plan dated November 2018 revealed the plan was developed based on the findings on 10/19/2018. Topics identified include: Process deviation noted by the Critical Care Physician and also the Cath Lab Nurse. The Action plan did not include completion dates,.

Interview with Stroke Coordinator on 04/08/2019 at 12:05 PM confirmed no audits for obtaining a two licensed verification co-signature prior to adminstering Alteplase were not completed to evaluate the compliance of the strategies/actions of the identified goals.

Review of In-House Stroke Alert Altepase Administration Audit for only Physician A provided on 04/09/2019 at 12:55 PM revealed the identification of the Inclusion/Exclusion Criteria review and the Altepase administration ordered by Physician A for the period of 12/08/2018 to 03/30/2019. No audits was completed for Interventional Radiology Registered Nurse -Staff J and the Cath Lab/Interventional Radiology Registered Nurses was noted.