South Shore Hospital

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 43882 The Hospital was out of compliance for the Condition of Participation for Medical Staff. Findings included: Based on record review and interviews for one patient (Patient #1), in a total of 10 records reviewed, the Hospital failed to ensure that an accurate History and Physical Examination (H & P), to determine whether there is anything in the patient’s overall condition that would affect the planned course of the patient’s treatment, was completed and documented by a qualified member of the Medical Staff Cross Reference: 482.22(c)(5)(i) Medical staff responsibilities H&p- (358)”

“MEDICAL STAFF RESPONSIBILITIES - H&P CFR(s): 482.22(c)(5)(i) [ The bylaws must:] Include a requirement that-- (i) A medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, and except as provided under paragraph (c)(5)(iii) of this section. The medical history and physical examination must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oral and maxillofacial surgeon, or other qualified individual in accordance with State law and hospital policy. This Standard is not met as evidenced by: 43882 Based on record review and interviews for one patient (Patient #1), in a total of 10 records reviewed, the Hospital failed to ensure that an accurate History and Physical Examination (H & P), to determine whether there is anything in the patient’s overall condition that would affect the planned course of the patient’s treatment, was completed and documented by a qualified member of the Medical Staff. Findings included: Review of the Hospital policy titled, “Patient Health Record Policy” undated, included the following: -Patient health records shall be reviewed on an ongoing basis for timeliness, completeness, accuracy of information, and quality of documentation by the Health Information Management Department. Inpatient Documentation: A complete H&P should include the following minimum elements: - Review of relevant systems, including a minimum review of cardiovascular and respiratory systems. -A report of the physical examination, which must include all relevant body systems. Review of Patient #1 ’ s medical record included the following: -Speech and Language Pathology (SLP) evaluation dated 4/2/2025, indicated Patient #1 was admitted on 4/1/2025 after a Motor Vehicle Accident (MVA). The hospital course included a workup for altered mental status. SLP consult was ordered to assess oropharyngeal swallowing function and risk of aspiration. Further review of the SLP evaluation indicated Patient #1 had poor oral/dental hygiene and many missing teeth. The evaluation indicated Patient #1 presented with mild oral dysphagia in the setting of many missing teeth. The risk of aspiration was identified as low, but a Dysphagia Soft diet with thin liquid was recommended. Further recommendations included, remaining upright as possible for all oral intake, remain upright for 30-45 minutes after meals, and small bites/sips, eat/feed slowly. Aspiration precautions were identified. -Patient #1 ’ s After Visit Summary/Instructions dated 4/3/2025, indicated dysphagia status and diet recommendation as dysphagia soft. -Nursing note dated, 4/2/2025, indicated SLP placed patient on soft diet due to not having dentures. -Nursing noted dated, 4/3/2025 indicated patient is being discharged home. Discharge paperwork reviewed with patient. -Patient was readmitted on 4/8/2025 with myalgia and hyperglycemia. -Physician order dated 4/8/2025 at 5:10 P.M., indicated Regular consistent carb 2000k/calorie diet. - Review of History and Physical dated 4/8/2025 at 4:21 P.M. included, “History largely obtained from review of records as well as discussion with Patient ’ s wife with patient providing a limited history due to baseline Lewy Body dementia with patient developing some agitation just prior to my evaluation”. 10 Point Review of Systems (ROS) was negative other than the pertinent positives and negatives listed. Further review indicated a Head Eyes Ears Nose Throat (HEENT) exam was performed and did not indicate any abnormalities or missing teeth. -Nursing flowsheets dated 4/10/2025 indicated Patient #1 needs assist and setup with feeding. Diet type documented as a diabetic/consistent carb with a fair appetite. -Nursing assessments dated 4/8/2025, 4/9/2025, and 4/10/2025 indicate Patient #1 was forgetful, disoriented to time and short-term memory loss. HEENT assessments also indicated Patient #1 had missing teeth. During an interview on 5/15/25 at 10:38 A.M., the Hospitalist Medical Director said the type of diet a patient is ordered depends on clinical assessment also while considering Past Medical History, problem list, and prior discharge summary. The Medical Director said Physician documentation is by exception generally noting irregularities. The Medical Director said it was presumed Patient #1 had his/her dentures on admission on 4/8/25 and if the patient had no teeth, it would have been noted. The Medical Director was unsure where it would be documented that the patient had dentures. The admitting physician from the 4/8/25 admission was not available for an interview. Hospital staff made multiple phone calls to the involved physician and did not receive a return call back. Further review of the medical record did not indicate Patient #1 had dentures. During an interview on 11/28/25 at 11:20 A.M. Patient #1 ’ s family said the patient owned dentures but did not have them in the hospital during the second admission. The family then said Patient #1 only had two teeth. Review of Patient #1 ’ s discharge summary dated 4/10/25 indicated a rapid response was called at on 4/10/25 at 5:27 P.M. Patient #1 was reported to be eating dinner and started choking, Heimlich maneuver was performed, oral sweep and food was removed. Patient #1 was suctioned but was hypoxic (low oxygen level) and had a heart rate in the 30 ’ s. Further attempts at suctioning/removal of food were attempted. Patient #1 was confirmed a DNR/DNI and expired at 5:39 P.M.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 37556 Based on records reviewed and interviews for one (Patient #6) of 10 sampled patients, the Hospital failed to ensure Patient #6 was administered medications (Continuous Subcutaneous Insulin Infusion), in accordance with physician orders and Hospital Policy. Findings include: Review of the Hospital’s policy titled, Continuous Subcutaneous Insulin Infusion (CSII) (an insulin pump) Guidelines, undated, indicated that patients/family members must be trained in insulin pump therapy and be willing to take responsibility for glycemic management with the insulin pump while in hospital. The Patient/designee must demonstrate ability to manage the pump and have no contraindications for use while at the Hospital. The policy further indicated that the physician must place orders for patients using CSII while in the Hospital. Review of Patient #6’s medical record indicated he/she presented to the Emergency Department (ED) in May 2025 at approximately 12:29 P.M. and was admitted for medical management for possible aspiration pneumonia. Patient #6 had a history of cerebrovascular accident (CVA) with expressive aphasia (a language disorder that makes it difficult to speak fluently), Insulin Dependent Diabetes Mellitus, and Lewy Body Dementia. Patient #6’s Physician placed an order on 5/8/25 at 8:26 P.M., for nothing by mouth (food, drinks, or oral medication). Review of the Hospital’s Internal Investigation, dated 5/10/25, indicated that on 5/9/25 at approximately 1:00 A.M., an admitting nurse identified Patient #6 had on an insulin pump (a wearable device) and at this time he/she was found to be hypoglycemic (low blood sugar) with a blood glucose of 49 milligrams per deciliter (mg/dl) (normal fasting range is between 70 - 99 mg/dl). Patient #6 required intravenous (IV) 125 millimeters (ml) of Dextrose 10% to restore his/her blood glucose level. The Investigation further indicated the Physician’s left the insulin pump on Patient #6 and ordered an Endocrinology consult. Review of the Endocrinology Progress Note, dated 5/9/25 at 9:47 A.M., indicated Patient #6’s insulin pump (CSII) was discontinued per Policy, due to Patient #6/family member being unable to independently manage the insulin pump. Patient #6’s insulin pump was removed. There was no documentation to support Patient #6 had a physician’s order to use an insulin pump (CSII) at the Hospital. Patient #6 remined in the Hospital for approximately 21 hours without a physician’s examination for safety and/or a physician’s order for the insulin pump (CSII). During an interview on 5/14/25 at 12:50 P.M., Physican Assistant (PA) #1 cared for Patient #6 while in the ED. He said Patient #6 was non-verbal due to a past history of a stroke. PA#1 said he spoke with Patient #6’s wife but the conversation did not include Patient #6 ’ s medications as the pharmacy staff typically complete the medication reconciliation details once a patient is admitted. PA#1 said he reviewed Patient #6’s medications in the medical record and noted Patient #6 was on insulin; however, he was unaware Patient #6 was on an insulin pump (CSII) at the Hospital. PA #1 said he did not order insulin for Patient #6 while in the ED. During an interview with the Medication Safety Officer on 5/14/25 at 2:40 P.M., she said that she assisted with the initial review of Patient #6’s medication event on 5/9/25. The Medication Safety Officer said that upon further investigating the details of the event, she discovered that Patient #6’s ED Nurse saw that Patient #6 had on some sort of pump/device (later identified as an insulin pump/CSII) but failed to notify a physician to further evaluate for safety and a potential order for continued use at the Hospital. During an interview on 5/14/25 at 2:00 P.M., the Executive Director of Risk Management provided documentation of the Hospital’s Internal Investigation and review of Patient #6’s medication event on 5/9/25, however, she said there was no documentation to support the Hospital implemented system wide corrective actions in response to the event.”

“EMERGENCY SERVICES POLICIES CFR(s): 482.55(a)(3) [If emergency services are provided at the hospital --] (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. This Standard is not met as evidenced by: 40928 Based on interviews and records reviewed, the Hospital failed to ensure physician orders were followed for 1 patient (Patient #2) out of a total sample of 10 patients. On 1/3/25 Patient #2 arrived at the Emergency Department (ED) via ambulance with reports of auditory hallucinations and feeling more anxious. After Patient #2 ’ s arrival to the ED on 1/3/25, Physician #1 ordered an Electrocardiogram (ECG) for Patient #2 which was not completed by staff. Findings included: Patient #2 arrived at the ED on 1/3/25 at 7:54 A.M. via ambulance for complaints of mania, hearing voices, and not taking his/her medications for 3 days. Patient #2 ’ s documented vital signs on 1/3/25 at 8:14 A.M. indicated a pulse rate of 108 (normal rate is between 60-100 beats per minute). Review of Patient #2 ’ s ED Provider Note filed on 1/4/25 at 7:18 A.M. indicated that Physician #1 evaluated the Patient on 1/3/25 at 9:53 A.M. and ordered an ECG (a non-invasive test that measures the heart ’ s electrical activity) to evaluate cardiac conduction. The Note further indicated that Physician #1 determined Patient #2 was medically stable for a psychiatric evaluation by the crisis team, who determined that Patient #2 required an involuntary inpatient psychiatric admission. Further review of Patient #2 ’ s medical record failed to indicate that the ECG ordered for Patient #2 on 1/3/25 at 9:57 A.M. was completed as ordered. Patient #2 was moved from the main ED to a room in the ED Annex (an area for medically stable patients awaiting psychiatric bed placement) on 1/3/25 at 4:07 P.M. Patient #2 was reassessed, and vital signs were obtained on 1/3/25 at 8:47 P.M. and he/she was administered medications as ordered by Registered Nurse (RN) #1. On 1/4/25 at 6:05 A.M., RN#1 entered Patient #2 ’ s room to administer his/her early morning medication and observed Patient #2 to be apneic (not breathing), cyanotic (skin has a bluish tint due to low oxygen blood levels) and pulseless. A Code was called, and cardiopulmonary resuscitation (CPR) was initiated. Review of ED Provider Note written by Physician #2 on 1/4/25 at 7:15 A.M. indicated that Patient #2 ’ s time of death was called on 1/4/25 at 6:28 A.M. The Medical Examiner ’ s office was contacted repeatedly and declined Patient #2 ’ s case. During an interview on 4/3/25 at 9:54 A.M., Physician #1 said he performed the medical exam for Patient #2 on 1/3/25. The Physician said he couldn ’ t remember specifically why he ordered the ECG for Patient #2 but that in general he will order an ECG if a patient has a heart rate over 100. He said he also may have ordered an ECG if he anticipated a patient might be restarted on an antipsychotic medication. Physician #1 said his expectation was that if patient orders are not followed and if an order can ’ t be completed, he would expect staff to inform him. During an interview on 4/3/25 at 3:38 P.M., the ED Clinical Nurse Coordinator said after this event he met with RN #1 to debrief. The ED Clinical Nurse Coordinator said that he had a general discussion with RN#1 regarding following physician orders. The ED Clinical Nurse Coordinator said this was not discussed with other nurses, nor was there any written documentation of what was discussed or formal re-education completed regarding following orders. During an interview on 4/08/25 at 9:11 A.M., RN#1 said he worked from 7:00 P.M.- 7:00 A.M. on 1/3/25-1/425 and was assigned to Patient #2 in the Annex. RN #1 said he received verbal report from the off-going nurse regarding Patient #2 and said that verbal report indicated Patient #2 was medically stable. RN#1 said he was not aware of any outstanding labs or orders, nor were any reported to him. He said Patient #2 was alert and oriented and had no complaints. RN#2 said he administered Patient #1 his/her 9:00 P.M. medications as ordered. RN #2 said he remembered hearing Patient #2 snoring during the night and seeing him/her move around in the med. RN #2 said he went to give Patient #2 his/her 6:00 A.M. medications on 1/4/25 and attempted to wake him/her with no response. RN #1 said he turned the light on and did a pulse check, and when he was unable to feel a pulse, he told the patient care tech to call a Code, and he began CPR. RN #1 said there was a robust response to the code but unfortunately Patient #2 was unable to be resuscitated. RN #1 said after the event, he participated in the hospital ’ s risk review and that he remembered learning that an ECG was ordered for Patient #2, and the ECG was not completed but said he was unaware of any education being completed regarding the ECG not being completed. During an interview on 4/08/25 at 11:20 A.M. the Executive Director of Risk Management said the Hospital reviewed Patient #2 ’ s medical record and event and identified an ECG ordered was not done. She said the Hospital did not have any documentation to support system wide corrective measures were developed or implemented in response to staff failing to complete a physician ’ s order.”