Bringing transparency to federal inspections
Tag No.: A0263
Based on record review and interviews, the Hospital failed to implement actions aimed at performance improvement following an adverse event for one Patient (#3) out of a total sample of 10 patients; Patient #3 experienced a hypotensive episode in an Intensive Care Unit (ICU) after the potential unintentional intravenous (IV) infusion of Nitroglycerin (a vasodilating medication used to lower blood pressure).
Refer to Tag - 0283
Tag No.: A0283
Based on record review and interview, the Hospital failed to implement actions aimed at performance improvement following an adverse event for one Patient (#3) out of a total sample of 10 patients; Patient #3 experienced a hypotensive episode in an Intensive Care Unit (ICU) after the potential unintentional intravenous (IV) infusion of Nitroglycerin (a vasodilating medication used to lower blood pressure).
Findings include:
Review of the Hospital policy titled "Medication Administration Policy", revised August 2022, indicated the following:
-IV medications should never be connected to a patient without being loaded in an infusion pump first.
-Connecting to a patient is always the LAST step when adding an infusion.
-Medication administration is recorded on a medication administration record (MAR), either paper or electronic. Documentation of each medication administration includes date, time, route, dose, and initials/electronic signature.
-Barcode scanning is the expected method of verifying patients and medications in areas using eMAR.
-Scan the barcode of the medication.
-The reason must be recorded in the eMAR for any medication documented without scanning.
-Although eMAR and the barcode scanning process automate many steps in the medication management process, they do not eliminate the need for the nurse's clinical judgement and attention to detail.
-Administration: Administer medications to the patient, complete documentation on the MAR.
-Medication Reconciliation: Nurses review the MAR at the beginning and end of each shift to ensure all doses are scheduled and addressed as ordered.
-Quality Assurance Process Improvement (QAPI): to ensure the safe administration of drugs, ongoing monitoring shall occur. These measures include automated reporting systems, direct and indirect observation and audits.
Review of the Hospital "Integrated Patient Safety, Quality, and Performance Improvement Plan 2022", dated March 2022, indicated the following:
-The leadership of the Medical Center and the Hospital System are responsible for identifying the priorities for patient safety, performance measurement, assessment, and improvement.
Review of the Hospital policy titled "Safety Event Reporting", revised March 2020, indicated the following:
-The following actions should be initiated immediately upon identification of an apparent sentinel event: Sequester the medical record and any equipment and medications involved, analyze the medical record and documentation. The Patient Safety Coordinators will assist, as appropriate, in facilitating/conducting a root cause analysis and developing corrective actions.
Patient #3 was admitted to the Hospital Emergency Department on 6/20/22 with diagnoses including chest pain, Non-ST elevated Myocardial Infarction (NSTEMI), and Coronary Artery Disease (CAD)
Review of Patient #3's medical record indicated Patient #3 underwent a Coronary Artery Bypass Grafting (CABG) procedure x3 coronary arteries (a surgical procedure to treat CAD by grafting blood vessels to the coronary arteries to allow blood flow to bypass coronary artery blockages) on 6/24/22 in the Hospital Operating Room. On 6/24/22 at 3:00 P.M., Patient #3 was transferred to the CVICU (Cardiac Surgery ICU) for post operative care; at that time the Patient was sedated and intubated with propofol (anesthetic/sedative medication) and phenylephrine (a medication used to increase blood pressure) infusing intravenously to the Patient. At approximately 3:30 P.M. on 6/24/22, the Patient became hypotensive and hemodynamically unstable. Review of Patient #3's vital signs indicated on 6/24/22 at 3:15 P.M. his/her blood pressure was 125/55, at 3:30 P.M. his/her blood pressure was 94/48, and at 3:35 P.M., his/her blood pressure was 23/13. The Nurse Practitioner (NP) and Anesthesiologist #1 were notified at 3:35 P.M. regarding Patient #3's change in blood pressure. Anesthesiologist #1 and the NP intervened at Patient #3's beside along with a Cardiac Surgeon. Patient #3 received boluses of IV fluids, epinephrine, norepinephrine, vasopressin (medications used to increase blood pressure), and amiodarone (A medication used to treat cardiac dysrhythmias, the Patient had also experienced atrial fibrillation during this event.) At 6:00 P.M. on 6/24/22, Patient #3 had become more stable with the medical interventions performed; an empty bottle of nitroglycerin was discovered to be attached to the Patient's IV central line following the event.
Review of the Hospital's Medication/Fluid event investigation indicated a medication/administration protocol was not followed for Patient #3 on 6/24/22. The investigation indicated on 6/24/22 RN #1 admitted Patient #3 to the CVICU with RN #2. Patient #3 had a hypotensive episode and around 6:00 P.M. on 6/24/22 observed an empty nitroglycerin bottle attached to the Patient. During the response to Patient #3's hypotensive event, multiple staff members were in and out of his/her room. Prior to Patient #3 arriving to the CVICU, RN #1 had dispensed a bottle of Nitroglycerin and set the medication up on one of the IV pumps in the room the Patient was to be admitted to. When Patient #3 arrived to the CVICU on 6/24/22, RN #1 detached the Patient from the syringe pumps from the operating room and attached the medications she had set up in Patient's room on the unit IV pumps to the Patient's IV access. RN #1 had said only the propofol and phenylephrine were infusing at that time. When the empty bottle of nitroglycerin was discovered attached to Patient #3 after the response to his/her hypotensive episode, the bottle's tubing was not connected to any pump. The Hospital investigation indicated RN #1 believed another staff member, who is unknown at this time, had removed the nitroglycerine from the infusion pump in order to set norepinephrine into the pump for infusion during the response to the Patient #3's hypotensive event; this would have opened the tubing to the nitroglycerine bottle and allowed the medication to free flow to the Patient's IV central line. Although there were multiple IV pumps in Patient #3's room, only the one pump which was assumed to have the nitroglycerine loaded into was sequestered for evaluation. The electronic log downloaded from the IV pump sequestered during the Hospital investigation indicated the pump was activated and out of sleep mode on at 3:41 P.M. on 6/24/22 and the first medication loaded into that pump on 6/24/22 was norepinephrine at 3:42 P.M; the Nitroglycerine was never loaded into the IV pump. The investigation indicated the corrective actions required change to the medication administration policy, new nurse orientation, and staff education through a hospital-wide nursing practice alert. Although multiple staff including RN #1 were interviewed, the Hospital investigation failed to indicate who had removed the nitroglycerine from a pump nor who would have set up the norepinephrine for IV infusion. The Hospital investigation also failed to indicate the logs of any other IV pumps which were in Patient #3's room on 6/24/22.
Further review of Patient #3's medical record indicated Patient #3 had arrived to the CVICU at 3:00 P.M. on 6/24/22 with an order in place for nitroglycerin 0-2 mcg/kg/min IV drip titrate to SBP < 120 with additional dosing and titrating instructions as well as an order in place for Phenylephrine 0 - 2.5 mcg/kg/min IV drip titrate to keep MAP > 60 with additional dosing and titrating instructions. Both orders were acknowledged by Registered Nurse (RN) #1 at 2:16 P.M. and posted in the MAR at 2:20 P.M. by RN #1 on 6/24/22. Patient #3's MAR indicated the Nitroglycerin was never started, for the reason it was not necessary, and the barcodes for the medication were never scanned. Patient #3's order detail for the nitroglycerin indicated the medication was available in 8mg (milligram) in a 20ml (milliliter) syringe and 100mg in a 250ml bottle. Patient #3's MAR failed to indicate that Norepinephrine was administered at 3:42 P.M., nor identify the staff member loading the medication into the IV pump for administration.
During an interview with the CVICU Nurse Manager on 12/15/22 at 9:30 A.M., she said had been notified of Patient #3's hypotensive event on 6/24/22 after the Patient had been stabilized. She said she had been notified an empty bottle of nitroglycerin was connected to Patient #3's IV central line. She said she interviewed RN #1 and RN #1 had said she had primed the nitroglycerine and loaded it into a sigma pump in case Patient #3 needed the medication; RN #1 could not remember if she had connected the IV tubing from the nitroglycerin to Patient #3. The Nurse Manager said it was typical practice for the nurses in the CVICU to pull medications ahead of time for Patients being admitted to the unit in case those medications were needed. She said she sequestered the pump RN #1 had said she thought the nitroglycerin had been set to but did not track any of the other pumps from Patient #3's room. She said the nitroglycerin had never been programmed to that pump. She said after the event, a nursing practice alert was sent via email to all the nurses on the CVICU as well as to nursing leadership/nurses across the Hospital and the medication administration policy had been updated.
During an interview with the Clinical Nurse Specialist on 12/15/22 at 10:10 A.M., he said the CVICU Nurse Manager had done the initial investigation on the incident involving Patient #3 on 6/24/22. He the Nurse Manager followed up with him after to review the case. He said based on the investigation it was believed at some point the nitroglycerin was put on an IV pump for Patient #3 on 6/24/22. He said during the investigation it was discovered the side clamp for the IV tubing connected to the nitroglycerin was not engaged after the event for Patient #3 on 6/24/22. He said during the hypotensive event on 6/24/22, Patient #3 was not responding to interventions, and the team was unsure if the nitroglycerin has started the hypotensive event. He said he was present on the CVICU on 6/24/22 and remembered a staff member had removed tubing from an IV pump to add another medication but was not sure who it was or what the medications were. He said corrective actions for the incident on 6/24/22 were put in place. He said the medication administration policy was updated and the new policy was incorporated into orientation for new nurses to the Hospital. He said the education for current nursing staff was entered in a nurse practice alert and sent via email to the nursing staff on the CVICU and to nursing leadership across the Hospital. He said there was not tracking done on the education. He did say the Hospital did have an online education system for in-services/training, but it was not utilized for this education.
During an interview on 12/15/22 at 11:30 A.M., RN #2 said she was present when Patient #3 admitted to the CVICU on 6/24/22. She said she was working on documentation while RN #1 was setting up Patient #3 in his/her room. She said RN #1 had detached the medications from Patient #3's IV from the operating room and was attaching medications to the Patient's IV set up on the IV pumps in his/her room. She said she remembered Patient #3 was getting propofol at that time and was unsure about any other medications. She said Patient #3 came from the operating room with medications (including nitroglycerine) connected to his/her IV via syringe pumps and had medication available if the medications were needed immediately. She said she did not know nitroglycerine had been set up in Patient #3's room. She said the usual practice on the unit is to gather medications ahead of time for the Patient but not set up the medications until needed. She said after Patient #3 was admitted to the unit he/she had a quick drop in blood pressure and required medications to try to stabilize his/her blood pressures.
During an interview with RN #3 on 12/19/22 at 9:00 A.M., she said she took over Patient #3's care on the overnight shift on 6/24/22. She said when she came in for her shift, she was given report Patient #3 had a hypotensive event and wasn't responding to interventions. She said by the time she started her shift, Patient #3 was still on propofol and sedated, and was on a high dose of Levophed (norepinephrine). She said typically there are 6 IV pumps in a patient room on the unit.
During an interview with the Patient Safety Coordinator on 12/19/22 at 11:50 A.M., she said an email was sent to all nursing staff with the practice alert regarding IV medication use. She said there are a total of 10 ICUs across the Hospital. She said no tracking had been done to verify all nursing staff were aware of the nursing practice alert. She said RN #1 maintained the nitroglycerine had been hooked into an IV pump when preparing medication for Patient #3. She said all nurses and staff involved in Patient #3's hypotensive episode were interviewed. No staff can remember hanging the norepinephrine that Patient #3 received. She said only one pump was sequestered and analyzed despite other pumps being in the room. She said staff should document in the Patient's medical record/MAR when administering medications; if an emergency is occurring, the staff should document after the Patient is stable.
The Hospital failed to provide any further documentation of verification that all nursing staff were aware of the policy changes and education provided on IV medication administration. The Hospital also failed to provide any further documentation for nursing medication administration of the norepinephrine, any investigation as to why the administration of the medication was not documented, nor any corrective action for the lack of documentation for the administration of a medication.