Tufts Medical Center

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 39257 Based on document review and interviews, the hospital failed (for one of ten patients sampled) to ensure the appropriate use of the hospital’s internal secure messaging system (TigerConnect) by a resident physician, resulting in an inadvertent medication error to Patient #1. Findings include: The hospital report, dated 09/24/2024, indicated that on 09/16/2024, a Post Graduate Year 1 (PGY-1) physician resident inadvertently ordered the medication Sotalol (a medication intended to affect heart rate and/or heart rhythm) for Patient #1 but the medication Sotalol was intended to be ordered for Patient #2. Patient #1 inadvertently received one dose of the Sotalol on 09/16/2024. Patient #1 remained at the hospital overnight for heart monitoring and Patient #1 was discharged the next day, on 09/17/2024. The document titled Solutions Plan, last updated 12/02/2024, indicated that the root cause of the medication error to Patient #1 was the incorrect use (ambiguity regarding which patient was supposed to receive Sotalol) of TigerConnect. The Solutions Plan indicated that education regarding appropriate use of Tiger Connect would be disseminated to all physician residents and/or physician fellows. The surveyor interviewed the Associate Chief Medical Officer (aCMO) for Quality on 12/16/2024 at 4:00 P.M. The aCMO for Quality confirmed that as of 12/16/2024 (the date that the survey commenced) no e-mail nor education had been disseminated to the residents/fellows physician base of the hospital despite the event occurring approximately three months prior, on 09/16/2024.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 41143 The Condition of Participation: Patient Rights was out of compliance. Findings included: Based on record review and interview the Hospital failed to ensure patients who are ordered for 1:1 observation are appropriately monitored and provided a safe care setting for one Patient (#2) out of a total sample of 12 patients; Patient #2 was able to ingest a screw and hypodermic needle while ordered for constant observation requiring surgical removal of the objects and on a later admission ingested hand sanitizer while on constant observation requiring admission to the intensive care unit (ICU) resulting in a finding of Immediate Jeopardy. An Immediate Jeopardy (IJ) event was identified on 11/2/23, regarding the Conditions of Participation (CoP) of Patient Rights for Patient #2 due to failure of the Hospital to: The Hospital was notified of the IJ event on 11/2/23. The Hospital presented a completed Removal Plan to the State Agency/CMS on 11/2/23, which was determined to be acceptable. In summary, the IJ event Removal Plan was implemented on 11/2/23 and consisted of multiple immediate action items including: The IJ event regarding the CoP of Patient Rights was removed on 11/6/23, when the State Agency/CMS verified by observation on nursing units, interview with staff, and review of all documentation, education attestations, and Patient records that the Removal Plan was fully implemented. CoP non-compliance for Patient Rights remains. Cross reference: 482.13 (c)(2) Patient Rights: Care in a Safe Setting (A0144)”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 41143 The Condition of Participation: Quality Assessment and Performance Improvement Program (QAPI) was out of compliance. Findings included: Based on record review and interview, the Hospital failed to ensure opportunities for improvement were identified and actions aimed at performance improvement were taken for one Patient (#2) out of a total sample of 12 patients, following review of an incident in which Patient #2 was able to ingest foreign objects while ordered for constant observation; Patient #2’s ingestion of foreign objects/substances resulted in in additional surgical procedures, ICU admissions, intubation, and acute alcohol intoxication while in the Hospital. Cross Reference: 482.21(c) - Quality Improvement Activities (A0283)”

“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: 41143 Based on record review and interview the Hospital failed to ensure patients who are ordered for 1:1 observation are appropriately monitored and provided a safe care setting for one Patient (#2) out of a total sample of 12 patients; Patient #2 was able to ingest a screw and hypodermic needle while ordered for constant observation requiring surgical removal of the objects and on a later admission ingested hand sanitizer while on constant observation requiring admission to the intensive care unit (ICU). Findings include: The Hospital policy titled “Suicided Risk Assessment, Prevention, and Precautions”, dated 11/14/22, indicated the following: -The responsible licensed provider will order the suicide precautions that provide the least restrictive environment necessary to maintain the safety of the patient. -Appropriate training in relation to risk screening and management of suicide, self-harm, and self-injury is provided to all clinical staff that care for patients at risk for suicide to ensure competence. -All Patients on suicide precautions will have a constant observer assigned. -If the Patient is on a medical/surgical unit, the room will be prepared using the room precautions for aggressive and suicidal patients checklist. -The Constant Observer will receive report from the Patient’s assigned nurse and initiate the Constant Observation Checklist/Behavioral Plan. -The Constant Observer will accompany the Patient to other hospital areas for tests or procedures. -The Constant Observer will stay with the Patient at all times except when relieved by nursing staff. -The Constant Observer will have eyes on the patient and be within distance that allows immediate intervention at all times, including toileting. -Room Precautions include removing peroxide, dressing supplies, betadine, or alcohol required for patient care upon completion of task. Patient #2 presented to the Hospital Emergency Department (ED) on 8/11/23 with complaints of left upper quadrant/abdominal pain and 4 episodes of vomiting blood after allegedly swallowing a thumb tack as a bet while consuming alcohol with friends the night before. Patient #2 underwent an esophagogastroduodenoscopy (EGD), (an endoscopic procedure used to examine the lining of the esophagus, stomach, and duodenum of the small intestine), however, the object was not located. Review of Patient #2’s medical record indicated an x-ray exam of Patient #2’s abdomen was obtained on 8/11/23 and a radiopaque foreign body was found to be projecting over his/her left upper abdominal quadrant. The Patient was ordered to have nothing by mouth (NPO). Patient #2 was admitted to an inpatient medical surgical unit on 8/12/23 for further care and treatment. On 8/12/2023, Patient #2 was found sitting on the edge of his/her bed with pills scattered on the floor. Patient #2 stated he/she ingested (approximately 13 tablets) of Wellbutrin (Anti-Depressant Medication). Patient #2’s belongings were secured and physician orders for 1:1 observation and suicide precautions were initiated. While under constant observation on 8/12/23, Patient #2 was able to grab a bottle of hand sanitizer in his/her room and ingest an unknown amount; the Physician was notified and the Patient was transferred to the ICU for monitoring and treatment secondary to inability to properly monitor on medical surgical unit. On 8/14/23 Patient #2 was evaluated by Psychiatric Nurse Practitioner (NP) #1 and recommendations were made to continue the 1:1 observation of the Patient as part of swallowing precautions for him/her. Repeat x-ray imaging demonstrated the continued passing of the foreign body over Patient #2’s right colon. Patient #2 transferred from the ICU to a medical surgical unit on the evening of 8/14/23. On 8/15/23, an abdominal X-ray was obtained for Patient #2 at 6:54 A.M. indicating the foreign body was projected over the Patient’s sigmoid colon. On 8/15/23, an abdominal CT exam was obtained for Patient #2 and indicated the foreign body was now located in the Patient’s stomach (the foreign body found in the Patient’s stomach had the same x-ray signature as the foreign body previously noted on diagnostic exam, suggesting it was the same item). Gastroenterology was consulted, and an endoscopic procedure (EGD) was performed on 8/15/23 and a screw was retrieved from the Patient’s stomach at 12:51 P.M. Upon Patient #2’s return to the unit from his/her endoscopy, the patient provided his/her nurse with the cap from an 18-gauge needle and indicated that he/she found the needle on the floor and ingested it. An abdominal x-ray exam performed for Patient #2 on 8/15/23 at 4:02 P.M. indicated a horizontal linear object projecting over the Patient’s right-mid abdomen. Patient #2 returned emergently for another endoscopy on 8/15/23 to remove the needle, which was successfully retrieved from the Patient’s small intestine. The anesthesia team performed a bronchoscopy (an endoscopic procedure performed to visualize the inside of a patient’s airways) on Patient #2, which indicated trauma and bleeding within the Patient’s trachea, and the Patient was left intubated and sedated and transferred to the ICU. The Patient was subsequently discharged on 8/17/23 after being evaluated by psychiatric services. Patient #2’s medical record failed to indicate any documentation of the constant observation/1:1 of the Patient from 8/12/23 - 8/15/23. The Hospital failed to provide any evidence of this documentation. On 10/24/23, Patient #2 returned to the ED with a complaint of abdominal pain after ingesting a coin. Patient #2 was admitted to the Hospital and ordered to have 1:1 observation secondary to his/her risk for foreign body ingestion. Review of Patient #2’s medical record indicated Patient #2 underwent an endoscopy on 10/24/23 and a penny was removed from his/her distal esophagus. On the evening of 10/25/23, Patient #2 was found by his/her 1:1 observer slumped on the toilet and unresponsive with vomit on his/her gown; the observer reported she had taken eyes off Patient #2 while the Patient was in the bathroom and did not continuously observe the Patient as ordered. Review of Patient #2’s Constant Observation Checklist dated 10/25/23 indicated he/she was toileting from 3:30 P.M. to 4:00 P.M. It was determined Patient #2 had drunk hand sanitizer (80% ethanol) and was found to have a serum ethanol level of 425. Patient #2 was transferred to the ICU for further care and monitoring. The Patient was evaluated by psychiatric services on 10/26/23 and discharged from the hospital on 10/27/23. During an interview with Psychiatric NP #1 on 11/1/23 at 11:38 A.M., she said Patient #2 was not acutely psychotic when admitted to the Hospital in August, however, did have substance use disorder. She said when the Patient returned to the medical surgical unit from the ICU on 8/14/23, he/she was placed in an inappropriate room for swallowing precautions with a roommate who had multiple items in the room. She said she contacted Risk Manager #1 and Patient #2 was moved to another room. She said when Patient #2 arrived at the Hospital on 10/24/23, it was her recommendation to place the Patient on 1:1 observation secondary to his/her risk of swallowing objects. She said the 1:1 observer reported she had left the Patient’s room on 10/25/23 to retrieve him/her a gown and returned to find him unresponsive in the bathroom. During an interview with Registered Nurse (RN) #1 on 11/1/23 at 12:26 P.M., she said the Patient arrived at the ICU with a 1:1 observer. She said patients requiring 1:1 or constant observation must have an observer with them at all times. She said the Patient went to the bathroom, he/she would require the 1:1 to go with him/her and keep sight of the Patient. During an interview with RN #2 on 11/1/23 at 12:36 P.M., she said the Patient transferred to the medical surgical unit on 8/14/23 with a constant observer. She said the Patient had bloody stools on the morning of 8/15/23 around 5:30 A.M. She said the constant observer notified her of the bowel movement. She said she was not sure if the object the Patient had swallowed prior to Hospital admission had passed or not. She said the constant observer kept the door open to the Patient’s bathroom while Patient #2 was moving his/her bowels. She said constant observers must maintain sight of patients ordered for constant observation at all times. The Hospital failed to ensure care was provided for Patient #2 in a safe environment; Patient #2 was able to ingest dangerous objects multiple times over two different admissions to the Hospital while he/she was ordered to have constant observation/suicide precautions resulting in surgical procedures, ICU admissions, intubation, and acute alcohol intoxication.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 41143 Based on record review and interview, the Hospital failed to ensure opportunities for improvement were identified and actions aimed at performance improvement were taken for one Patient (#2) out of a total sample of 12 patients, following review of an incident in which Patient #2 was able to ingest foreign objects while ordered for constant observation; Patient #2’s ingestion of foreign objects/substances resulted in in additional surgical procedures, ICU admissions, intubation, and acute alcohol intoxication while in the Hospital. Findings include: Review of the Hospital’s Quality and Patient Safety Plan, dated 2023, indicated the following: -Root Cause Analysis (RCA) should be held when there is a serious safety event in which there was death or sever permanent or temporary harm and/or moderate permanent or temporary harm. -Solutions should focus on the most critical contributing factors of the event. -Identify core team (safety Event Huddle): Care team members include both clinical and nonclinical with firsthand knowledge of the case. -Safety Event Huddle: Identify immediate actions needed to prevent future occurrences Patient #2 presented to the Hospital Emergency Department (ED) on 8/11/23 with complaints of left upper quadrant/abdominal pain and 4 episodes of vomiting blood after allegedly swallowing a thumb tack as a bet while consuming alcohol with friends the night before. Patient #2 underwent an esophagogastroduodenoscopy (EGD), (an endoscopic procedure used to examine the lining of the esophagus, stomach, and duodenum of the small intestine), however, the object was not located. Review of Patient #2’s medical record indicated an x-ray exam of Patient #2’s abdomen was obtained on 8/11/23 and a radiopaque foreign body was found to be projecting over his/her left upper abdominal quadrant. The Patient was ordered to have nothing by mouth (NPO). Patient #2 was admitted to an inpatient medical surgical unit on 8/12/23 for further care and treatment. On 8/12/2023, Patient #2 was found sitting on the edge of his/her bed with pills scattered on the floor. Patient #2 stated he/she ingested (approximately 13 tablets) of Wellbutrin (Anti-Depressant Medication). Patient #2’s belongings were secured and physician orders for 1:1 observation and suicide precautions were initiated. On 8/15/23, an abdominal X-ray was obtained for Patient #2 at 6:54 A.M. indicating the foreign body was projected over the Patient’s sigmoid colon. While under constant observation on 8/12/23, Patient #2 was able to grab a bottle of hand sanitizer in his/her room and ingest an unknown amount. On 8/15/23, an abdominal CT exam was obtained for Patient #2 and indicated the foreign body was now located in the Patient’s stomach (the foreign body found in the Patient’s stomach had the same x-ray signature as the foreign body previously noted on diagnostic exam, suggesting it was the same item). Gastroenterology was consulted, and an endoscopic procedure was performed on 8/15/23 and a screw was retrieved from the Patient’s stomach at 12:51 P.M. Upon Patient #2’s return to the unit from his/her endoscopy, the patient provided his/her nurse with the cap from an 18-gauge needle and indicated that he/she found the needle on the floor and ingested it. Patient #2 returned emergently for another endoscopy on 8/15/23 to remove the needle which was successfully retrieved from the Patient’s small intestine. The anesthesia team performed a bronchoscopy on Patient #2, which indicated trauma and bleeding within the Patient’s trachea, and the Patient was left intubated and sedated and transferred to the ICU. Review of the Hospital’s Solution’s Plan dated 10/24/23 indicated the following: -Event summary: Patient registered in the wrong chart was not flagged for risk of self-harm and ingested pill and a needle. -Root Cause - Registration did not ask the Patient for information, only yes/no questions. -Interventions - 1:1 coaching around expectations for arrival and registration, each staff member was provided a copy of the ED tip sheet and re-educated on using open-ended questions. -Root Cause - Patient registered under wrong patient account. Correct account had a flag for self-harm. -Creation of Registration of Anonymous Patients policy, Creation of Patient Identification Policy, Creation of Patient Flagging policy (all to be determined for completion date.) -Root Cause - Patient with history of foreign body ingestions was not provided appropriate safety precautions. Interventions- Hiring of mental health specialists (CCTs) for care of high-risk patients (ongoing), Education CCTs around constant observation, updating the Hospital’s policy “Suicided Risk Assessment, Prevention, and Precautions”. (Completion dates ongoing and to be determined). During an interview with Risk Manager #1 on 11/1/23 at 9:50 A.M., she said Patient #2 was admitted to the Hospital on 8/11/23 after ingestion of a foreign object. She said Patient #2 was found by a Registered Nurse (RN) bent over his/her bed with pills scattered on the floor; the Patient had ingested 13 tabs of his/her home medication. She said the Hospital was unaware of the Patient’s history of ingestion behaviors secondary to the Patient #2 providing a false identity on admission. She said Patient #2 was believed to have re-ingested the object which had passed through his/her colon; Patient #2 also subsequently ingested a needle following removal of the initial object. She said the Hospital conducted a RCA regarding Patient #2, she said the root cause of the Patient ingesting foreign objects while in the Hospital was incorrect registration. She said a goal of the Hospital was to hire CCTs for 1:1 observation of patients with complex behaviors. She said it was not known how the Patient was able to ingest the object which passed through his/her colon despite constant observation. She said it was not known how Patient #2 obtained the needle he/she swallowed despite being on constant observation. She said it was unknown what the constant observer assigned to the Patient at the time of the ingestions was doing. She was unable to provide the names of the staff providing the constant observation for Patient #2. She said no additional training was provided to any staff who provided constant observation for Patients in the Hospital. During an interview with Occupational Therapist (OT) #1 on 11/1/23 at 12:00 P.M., she said she oversees the CCTs who provide 1:1 observation. She said she will evaluate patients utilizing an OT assessment tool and will pass the plan of care to the CCTs. She said she will receive notification if a patient requires constant observation and can decide if a CCT should be utilized for that patient’s observation. She said there are not enough CCTs to provide all constant observation in the Hospital, and other staff (nursing assistants, patient care technicians, etc..) can but utilized to provide constant observation to patients. She participated in the RCA process for Patient #2’s incidents; staff receive annual training on suicide/self-harm precautions, however, no additional training resulted from this event. She said suicide precaution trianing includes constant observers keeping sight of patients at all times. The Hospital failed to provide any documentation of the constant observation for Patient #2 from 8/12/23 through 8/15/23. The Hospital policy titled “Suicided Risk Assessment, Prevention, and Precautions” effective date was 11/14/2022 and failed to indicate any new revisions following the events in August 2023 for Patient #2. The Hospital failed to provide any evidence of updated training to CCTs or any staff regarding constant observation of patients. Further medical record review indicated on 10/24/23, Patient #2 returned to the ED with a complaint of abdominal pain after ingesting a coin. Patient #2 was admitted to the Hospital and ordered to have 1:1 observation secondary to his/her risk for foreign body ingestion. On the evening of 10/25/23, Patient #2 was found by his/her 1:1 observer slumped on the toilet and unresponsive with vomit on his/her gown; the observer reported she had taken eyes off Patient #2 while the Patient was in the bathroom and did not continuously observe the Patient as ordered. Review of Patient #2’s Constant Observation Checklist dated 10/25/23 indicated he/she was toileting from 3:30 P.M. to 4:00 P.M. It was determined Patient #2 had drunk hand sanitizer (80% ethanol) and was found to have a serum ethanol level of 425. Patient #2 was transferred to the ICU for further care and monitoring. The Patient was evaluated by psychiatric services on 10/26/23 and discharged from the hospital on 10/27/23. The Hospital failed to ensure opportunities for improvement were identified and actions aimed at performance improvement were taken following foreign body ingestions by Patient #2. Subsequently, Patient #2 was admitted to the Hospital a second time and was able to ingest hand sanitizer after a lapse of observation by his/her assigned constant observer.”