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The Condition of Participation: Anesthesia Services was out of compliance.

Based on record review and interview, the Hospital failed to ensure Anesthesia services were provided in a manner consistent with needs and resources for one Patient (1) out of a total sample of 10 patients. Patient #1 was inadvertently infused with phenylephrine intravenously (IV) (a pressor medication used to raise blood pressure) during a Cesarean Section (C-Section) procedure, experienced profound hypertension (high blood pressure) and bradycardia (low heart rate), and required multiple medications to reverse his/her hypertension.

Cross Reference:
482.52(b) - Delivery of Anesthesia Services (1002)

Based on record review and interview, the Hospital failed to ensure Anesthesia services were provided in a manner consistent with needs and resources for one Patient (1) out of a total sample of 10 patients. Patient #1 was inadvertently infused with phenylephrine intravenously (IV) (a pressor medication used to raise blood pressure) during a Cesarean Section (C-Section) procedure, experienced profound hypertension (high blood pressure) and bradycardia (low heart rate), and required multiple medications to reverse his/her hypertension.

Review of the Hospital Policy titled "Serious Reportable Events Policy", dated 9/5/23, indicated the following:
-Once factfinding is completed, the Healthcare Facility Patient Safety Department will follow local reporting structures for next steps. If it is determined that an improvement action meeting will be held, the meeting will be conducted in line with principles of Equity-Informed High Reliability. The goal of the meeting is to choose the appropriate initial improvement actions and monitoring plans. Unit leadership will cascade learnings to staff and report out at the appropriate committees.

Patient #1 presented to the Hospital on 5/27/25 at 8:30 A.M. for admission to the Labor and Delivery (L&D) unit for induction of labor as he/she had a high-risk pregnancy and had a history of gestational hypertension and traumatic separation of the pubic symphysis.

Review of Patient #1's medical record indicated on 5/28/25 around 1:00 P.M., the decision was made with the Patient to undergo a C-section as his/her labor was not progressing and the Patient's Pitocin (a medication used to stimulate uterine contractions for labor) could not be titrated. Patient #1 was induced with neuraxial anesthesia (anesthesia administered to the epidural spinal cord through a catheter to block the nerves) on 5/28/25 at 1:16 P.M. and Patient #1's C-section procedure began on 5/28/25 at 1:29 P.M. in a L&D unit operating room (OR). Following the delivery of a neonate, Patient #1 experienced sudden bradycardia (heart rate 37) at 2:27 P.M. and hypertension (blood pressure 230/119) at 2:28 P.M. on 5/28/25, followed by severe headaches; a code stroke was called. Patient #1 was closed with staples by the Obstetrics/Gynecology surgeon (OB/GYN). An arterial line was inserted into Patient #1's right arm to monitor the Patient's hemodynamic stability. Patient #1 received IV nitroglycerine, labetalol, magnesium, and hydralazine (all medications used to lower blood pressure). Patient #1 remained hypertensive until 2:43 P.M. on 5/28/25. At 2:50 P.M. on 5/28/25, while preparing to transfer Patient #1 for a computed tomography (CT) examination of his/her brain, it was discovered the Patient still had a bag of phenylephrine attached to his/her IV device which was removed from its IV pump and the roller clamp was not completely occluded on the tubing and phenylephrine had unintentionally infused without a pump into the Patient's IV device. Patient #1 was evaluated by neurology on 5/28/25 at 4:02 P.M. and the Patient experienced the sudden rise in blood pressure and decrease in heartrate due to the phenylephrine infusion.

During an interview with Anesthesiologist #1 on 7/16/25 at 11:30 A.M., she said on 5/28/25 the decision was made to deliver Patient #1's infant via C-section, and the Patient was brought to the L&D OR. She said Patient #1's C-section procedure was typical, and the infant was delivered without issue. She said she relieved the Anesthesia Resident to finish the case. She said the phenylephrine was not needed anymore and she removed it from the IV pump after turning the IV pump off. She said when the IV tubing is removed from the IV pump, the first clamp is applied to open the pump and then the roller clamp on the tubing should be closed. She said the final step in removing an IV medication is to disconnect the patient's IV device from the IV tubing. She said once the phenylephrine IV tubing was removed from the IV pump and clamped, she had not disconnected the IV tubing from the Patient's IV device; the Patient's significant other was next to the Patient on his/her left side, blocking the Patients left arm from access. She said Patient #1 became suddenly bradycardic and hypertensive and stated he/she had a horrible headache. She said multiple antihypertensive medications were administered to Patient #1, the Patient's blood pressure decreased, and his/her headache had improved. She said it was planned to move Patient #1 to an Intensive Care Unit (ICU) bed following a CT exam of the Patient's head. She said while preparing Patient #1 for transport, it was discovered the Patient was still connected to the phenylephrine bag which had possibly infused into Patient #1's IV device as the roller clamp was not completely closed. She said she did not check the IV tubing clamp which inserts into the IV pump and was not sure if the clip failed; the tubing was not kept after the event. She said the incident was disclosed to Patient #1 and the Patient's significant other. She said this was likely a reportable event to the State Agency. She said the entire OR team from the case debriefed on the incident with Patient #1 and she notified the Anesthesia Quality Assurance (QA) Nurse/Coordinator for review of the case. She said she presented Patient #1's case at the OB Anesthesia M&M (morbidity and mortality) conference regarding the events of the case and disclosure of events to patients and families. She said a newsletter would be released to bring the Hospital's attention to the issues with Patient #1's case. She said there was discussion at the M&M conference regarding the sequence of discontinuing an IV medication for a patient (disconnecting the patient from the IV tubing during the first step instead of the last step), and simulation for Anesthesia Residents starting their placements at the Hospital. She said the Hospital was discussing a change to cassette loaded IV pumps, which are not gravity dependent.

During an interview with Anesthesiologist #2 on 7/16/25 at 12:40 P.M., she said she responded to the code stroke called for Patient #1 on 5/28/25 in the L&D OR. She said Patient #1 was hypertensive but had no phenylephrine running on the IV pump. She said she saw a new bag of phenylephrine hanging on the IV pole and primed with IV tubing but was not attached to the Patient.

During an interview with RN #1 on 7/16/25 at 1:30 P.M., she said she was circulating Patient #1's C-section on 5/28/25. She said she had cared for Patient #1 on 5/27/25 as well. She said Patient #1's labor was not progressing and was brought to the L&D OR for the C-section procedure. She said at the same time, another case was being performed in the other OR suite on the L&D unit. She said Patient #1's case was urgent; however, the C-section went well and Patient #1's infant came out without issue during the procedure. She said Patient #1 had some bleeding during the C-section, and the OB physicians were closing the Patient's surgical wound. She said she was at the side of the OR checking on the infant and the Patient's significant other. She said Patient #1's monitor began showing the Patient's heart rate to be in the 30's with s systolic blood pressure over 200. She said the anesthesiologist was asking the OB physicians if anything was going on with Patient #1; the OB physician's said there was no reason Patient #1's vitals should be presenting that way. She said the decision was made to switch from suturing the Patient's wound to stapling it for closure. She said everyone was trying to figure out what was happening with Patient #1 and a code stroke was called. She said magnesium was infused IV for Patient #1 and the Patient received antihypertensive medications. She said Patient #1's vital signs were stabilized and was waiting for an ICU bed. She said neurology was evaluating Patient #1 and the Patient was going to get a STAT CT exam. She said it was then discovered the Phenylephrine bag was attached to Patient #1's IV device and was mostly empty. She said the OR team debriefed following the event with Patient #1, and there was a question of safety around the IV clip/clamp. She said during the C-section the Patient's significant other was blocking the Patient's IV, and the IV tubing from the phenylephrine was not disconnected from the Patient.

During an interview with Anesthesiology Resident #1 on 7/16/25 at 2:00 P.M., she said she was working Patient #1's C-section on 5/28/25. She said towards the end of the C-section, the attending anesthesiologist (Anesthesiologist #1) relieved her to take a break, which is typical practice. She said she left the OR for about 10 minutes and when she returned to the OR Anesthesiologist #2 was entering the OR just ahead of her. She said Patient #1's blood pressure was elevated, and the Patient was in distress with a bad headache. She said Anesthesiologist #1 was managing the code. She said when she had initially left the OR, phenylephrine was infusing at a low rate for Patient #1. She said she asked about the Phenylephrine, and Anesthesiologist #1 said the phenylephrine infusion was turned off. She said she inserted the arterial line for Patient #1 to monitor Patient #1's blood pressure closely, which was improving with intervention. She said she discovered the phenylephrine bag still connected to Patient #1 with less medication in the bag than she would have expected. She said towards the end of a C-section case, sometimes the anesthesiologists will start to turn over the room, taking down medications not being used and disposing of them, and cleaning pumps to reload the medications in order to be ready in case an urgent C-section is needed for another patient as there are only two ORs on the L&D unit. She said there have been times when the IV tubing clamps and roller clamps don't fully engage and block the IV tubing flow. She said there had been times in the past when she felt the need to watch a patient's IV medication because she was concerned regarding the roller clamp function on the IV tubing.

During an interview with the Supply Chain Manager on 7/16/25 at 4:09 P.M., she said the Hospital has not had any issues obtaining IV tubing from its contracted vendor. She said she was not aware of any IV tubing complaints/malfunctions. She said the IV tubing products from the contracted vendor have remained the same.

During an interview with the Anesthesiology QA Nurse/Coordinator on 7/17/25 at 8:30 A.M., she said she was notified on the evening of 5/28/25 regarding the incident with Patient #1's C-section procedure. She said she reviewed the incident with Anesthesiologist #1 on the morning of 5/29/25. She said she notified the Chair of Quality for the Hospital's organization and notified the Hospital's compliance and quality team (CQS). She said she reviewed Patient #1's medical record. She said she reached out to a Clinical Nurse Specialist regarding the case. She said an unfortunate issue with the IV tubing compatible to the IV pumps in the Hospital is that the clamps used when removing the tubing from the IV pump need to really need to be engaged to remove the tubing from the pump. She said an action item for the Hospital to work on is to ensure IV tubing is disconnected from a patient when removing/stopping an IV med. She said there is discussion/planning to change from gravity fed IV pumps to cassette pumps in 2026.She said in Patient #1's case, the clamp was not fully engaged on the IV tubing of the phenylephrine. She said on 6/2/25, CQS indicated Patient #1's case was not a reportable event, as the Patient was not moved to a higher level of care, however, she felt this event needed to be taken to the Anesthesia M&M for review. She said during the incident with Patient #1, the Patient's significant other may have been a potential distraction during the case. She said when the Patient experienced hypertension and bradycardia during the C-section procedure, the team in the OR was focused on treating the symptoms but not discovering why the symptoms were occurring. She said she participated in the Hospital's Collaborative Case Review (CCR) for Patient #1's incident and coordinated with the OB Anesthesia Chief. She said this case and action items would be presented at the quarterly division chief meeting for all anesthesia services next month. She said for anesthesia residents new to the Hospital, initial training would include the IV pump process and issues and education regarding asking support persons brought into the OR for patients delivering infants via C-section to move when necessary to access a patient. She said an alert newsletter regarding the IV tubing clamps and pumps would be distributed but it has not been sent yet. She said she was not sure of the usual practice for anesthesia turnover between cases for OB anesthesia.

During an interview with the OB/GYN Physician on 7/17/25 at 1:00 P.M., she said on 5/28/25 the main part of Patient #1's C-section had been completed. She said OB was working on closing the Patient's incision when the Patient suddenly went bradycardic. She said Patient #1 quickly needed to have his/her incision closed so suturing was stopped and staples were used. She said everyone in the OR was confused as to what caused the change in Patient #1 until one of the anesthesia residents discovered the phenylephrine bag. She said if both L&D ORs are being utilized and a third patient requires a C-section, that patient could be transferred to the Hospital's main OR for the C-section.

During an interview with the OB Anesthesia Chief on 7/17/25 at 1:30 P.M., she said Patient #1's case was reviewed during a Hospital CCR. She said action items discussed in relation to the case were presenting pictures of the tubing/pump, guidance for the sequence of events in loading/unloading IV tubing and medication from IV pumps and patients and managing patient support persons during C-sections. She said some of the action items from Patient #1's case are relevant to all anesthesia practice in the Hospital, and there be more meetings on this. She said there has not been many concerns around the Hospital's IV pumps. She said Patients should always be attached to IV tubing once it is primed and loaded in the IV pump and should always be detached before removing the IV tubing from the IV pump; there is not written protocol for the sequence of starting and removing an IV medication. She said following a case generally environmental services begin room turnover and cleaning, and the anesthesia techs begin setup. She said typically anesthesiologists do not start setting up medications until an OR has been turned over following a case.