Massachusetts General Hospital

“ANESTHESIA SERVICES CFR(s): 482.52 If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital. This Condition is not met as evidenced by: 41143 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)”

“DELIVERY OF ANESTHESIA SERVICES CFR(s): 482.52(b) Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies must ensure that the following are provided for each patient: This Standard is not met as evidenced by: 41143 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.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 37556 The Condition of Participation: Patient Rights was out of compliance. Findings included: Based on interviews and record reviews, the Hospital failed to provide care in a safe setting for one of ten sampled patients (Patient #2), when Patient #2, who was assessed as high-risk of self-harm behaviors and suicide attempts, and required a continuous one-to-one patient safety observer, ingested a cordless phone battery on 9/8/23, which required an x-ray scan and an endoscopic procedure to remove the battery on 9/10/23. Cross Reference: 482.13(c)(2): Patient Rights: Care in a Safe Setting (144).”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 41143 The Condition of Participation: Pharmaceutical Services. Findings included: Based on record review and interviews the Hospital failed to ensure medication orders were reviewed for appropriateness before the first dose was dispensed to one Patient (#1) out of a total sample of 10 Patients; Patient #1 received a dose of methadone (an opiate medication) intended for another patient and experienced respiratory depression and opiate intoxication requiring naloxone (medication used to treat Narcotic overdose) resuscitation and Intensive Care Unit (ICU) level of care. resulting in a finding of Immediate Jeopardy. An Immediate Jeopardy (IJ) event was identified on 1/4/24, regarding the Conditions of Participation (CoP) of Pharmaceutical Services for Patient #1. The Hospital was notified of the IJ event on 1/4/24. The Hospital presented a completed Removal Plan to the State Agency/CMS on 1/8/24, which was determined to be acceptable. In summary, the IJ event Removal Plan was implemented on 1/5/24. The IJ event regarding the CoP of Pharmaceutical Services was removed on 1/8/24, when the State Agency/CMS verified by interview with staff, review of all documentation, education attestations, and Patient records that the Removal Plan was fully implemented. CoP non-compliance for Pharmaceutical Services remains. Cross reference: 482.25 (b) Pharmaceutical Services: Delivery of Services (A0500)”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 37556 Based on interviews and record reviews, the Hospital failed to provide care in a safe setting for one of ten sampled patients (Patient #2), when Patient #2, who was assessed as high-risk of self-harm behaviors and suicide attempts, and required a continuous one-to-one patient safety observer, ingested a cordless phone battery on 9/8/23, which required an x-ray scan and an endoscopic procedure to remove the battery on 9/10/23. Findings include: Review of the Hospital’s Suicide Risk Assessment and Risk Mitigation policy, dated August 2023, indicated its purpose was to ensure safety of patients who were at risk of suicide on the inpatient psychiatric unit. The policy indicated the one-to-one observer would always keep the patient (especially hands) in direct view, even when toileting. Review of the Department of Public Health’s Health Care Facility Reporting System (HCFRS), dated 9/18/23, indicated the Hospital reported that Patient #2 was admitted to the inpatient pediatric unit in May 2023 for stabilization of nutritional deficiency and transferred to the inpatient psychiatric unit on 6/2/23, for treatment of food refusal in the context of trauma at home with increased flashbacks. The Hospital’s report indicated that on 9/10/23 Patient #2 told staff that on 9/8/23 he/she swallowed a cordless phone battery. The report indicated following Patient #2’s adverse event, his/her care plan’s safety interventions were increased, and Patient #2 underwent an endoscopic removal of the batteries from his/her stomach on 9/10/23. Further review of the Hospital’s report indicated the Hospital was unable to determine if the Patient #2’s adverse event, of ingesting a foreign object while under one-to-one safety observation on 9/8/23, was preventable or not due to the complexity of Patient #2’s case at the time of the event. Review of the Hospital’s Internal Investigation, dated 9/10/23, indicated that Patient #2 did not disclose ingesting a foreign object until staff confronted him/her about a missing phone battery from a phone he/she used two days earlier. The Investigation indicated that Patient #2 denied swallowing the battery and attempted to refuse the x-ray scan to try to locate battery. The Investigation indicated that just prior to Patient #2’s x-ray scan, he/she reported swallowing the battery as a suicide attempt on 9/8/23. During an interview on 1/8/24 at 12:20 P.M., the Nurse Manager said she assisted with the investigation and review of Patient #2’s adverse event on 9/8/23. The Nurse Manager said Patient #2 swallowed the battery while under one-to-one safety observation; however, the missing battery was not identified until two days later. The Nurse Manager said the review of the adverse event did not identify any need systematic changes/staff re-education on safety supervision to improve patient safety on the unit. During an interview on 1/4/24 at 11:02 A.M., the Director of Clinical Compliance said he was not directly involved in the Investigation/RCA process involving Patient #2’s adverse event on 9/8/23; however, he acknowledged the Hospital was unable to determine if the adverse event was preventable or not, and there were no system-wide corrective actions and/or staff re-education resulting from the Hospital’s completed review.”

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 41143 Based on record review and interviews the Hospital failed to ensure medication orders were reviewed for appropriateness before the first dose was dispensed to one Patient (#1) out of a total sample of 10 Patients; Patient #1 received a dose of methadone (an opiate medication) intended for another patient and experienced respiratory depression and opiate intoxication requiring naloxone (medication used to treat Narcotic overdose) resuscitation and Intensive Care Unit (ICU) level of care. Findings include: Review of the Hospital Policy titled “Pharmacist Medication Order Evaluation, Intervention, and Verification Process”, dated 8/2023, indicated the following: -A pharmacist reviews the appropriateness of medication orders for medications to be dispensed in the Hospital prior to dispensing of the medication. -The Pharmacist intervenes upon medication orders that are incomplete, illegible, or unclear or that require clarification due to accuracy or appropriateness of order. -The Pharmacist reviews medication order for accuracy and appropriateness by considering: patient allergies or sensitivities, patient measurements, existing or potential interactions between medication and contaminant medications and/or food, indication, appropriateness of dose, frequency, and route of administration, appropriateness of therapy with consideration to pertinent laboratory values, therapeutic duplication, contraindications to therapy, relevant hospital guidelines. -If all elements are considered acceptable, the pharmacist verifies the medication orders. Patient #1 presented to the Hospital Emergency Department (ED) on 10/17/23 with chills, leg pain, and congestion. Review of Patient #1’s medical record indicated the Patient was evaluated by a Physician on 10/17/23 at 8:09 A.M. Patient #1’s chief complaint was chills, and Patient #1 was evaluated to have symptoms of an Upper Respiratory Infection (URI) and subsequently diagnosed to have a COVID-19 infection. On 10/17/23, at 9:16 A.M., Physician Assistant (PA) #1 entered orders for Methadone 110 Milligrams (mg) orally to be administered to Patient #1. The order was reviewed by Pharmacist #1 and verified. At 9:40 A.M., RN #1 administered 110 mg of methadone orally to Patient #1. At 12:00 P.M. Patient #1 was documented as being somnolent (excessively sleepy) and after a Physician’s evaluation, found to be in acute opioid intoxication secondary to Methadone administration. The Physician documented the methadone was intended for another patient and not Patient #1. At 12:17 PM, Patient #1 was administered Narcan (naloxone) 0.4 mg intravenous (IV). Patient #1 continued to remain minimally responsive to examination and at 12:27 P.M., was administered a continuous Narcan IV infusion 1.2mg/hr. At 4:16 P.M, Patient #1 was transferred to the ICU for further care. Patient #1 was somnolent on arrival to the ICU. During the evening of 10/17/23, Patient #1 became more apneic with respiratory rates under 10 causing respiratory acidosis and required an increase in Narcan infusion rate with additional boluses of Narcan. On 10/18/23 at 3:46 A.M., Patient #1 required a Levophed infusion to be started to manage his/her hypotension (drop in blood pressure) due to shock likely caused by his/her methadone overdose. Further review of Patient #1’s medical record failed to indicate any history, diagnosis, or indication of Patient #1 having a history of substance use or opiate use disorder, nor was there any history of Patient #1 ever receiving any controlled substances prior to his/her admission on 10/17/23 to the Hospital. During an interview with the Chair of Quality and Safety for Emergency Medicine on 1/4/24 at 1:10 P.M., he said on 10/17/23 PA #1 was caring for multiple patients in the ED including Patient #1. He said PA #1 obtained all the information from the other patient’s clinic for his/her methadone dose but had Patient #1’s chart open in the electronic medical record and entered the methadone order for Patient #1. He said the Pharmacist (Pharmacist #1) then verified the order. He said PA #1 was reviewing Patient #1’s medical record later on 10/27/23 and realized the methadone had been incorrectly ordered for the Patient and notified the attending physician. The Patient was then evaluated and moved to a more urgent care area in the ED at that time. He said he did counsel PA #1 after the event and meetings were held after the event and initial investigation to explore how to prevent this incident from occurring again. He said at this time, no clear interventions have been put in place. During an interview with Pharmacist #1 on 1/4/24 at 2:30 P.M., she said a provider must enter information for Patient’s utilizing methadone for substance use disorder such as the clinic attended, diagnosis, usual dose prescribed, and last dose taken. She said on 10/17/23 PA #1 entered all the necessary information for the methadone order in Patient #1’s medical record. She said when she reviewed the order for methadone for Patient #1 on 10/17/23, she reviewed the ED notes for the Patient. She said during the record review for Patient #1 that while there was no history of methadone/opiate use for Patient #1, he/she did come to the ED with chills, and it is not uncommon for patients to have started opiate use/methadone use outside of the Hospital. She said it is challenging to patients for substance abuse. She said when pharmacists at the Hospital review medication orders for verification so that medications can be administered to patients, the review process depends on the type of medication; she did not reference the Hospital’s policy for medication verification, which lists criteria by which all medications must be reviewed. During an interview with the Pharmacy Director of Med use Safety, Policy, Compliance, and Informatics on 1/4/24 at 2:15 P.M., she said any changes or interventions related to the incident with Patient #1’s medication error on 10/17/23 are still pending the interdisciplinary team’s collaboration. The Hospital failed to ensure Patient #1’s order for methadone was reviewed for appropriateness, resulting in medication error and subsequent methadone overdose, respiratory suppression, shock, and ICU transfer for Patient #1.”