Carolinas Medical Center-Northeast

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 41345 Based on review of hospital policy, closed medical record review, and staff interviews, the hospital failed to provide repeat neurological evaluations while Patient #3 was awaiting admission for one (1) of 30 sampled patients that presented to the hospital’s dedicated emergency department with an emergency medical condition, (Patient #3). Findings included: A policy titled “EMTALA compliance, Including Patient Transfers (Emergency Medical Treatment and Labor Act)” approved October 28, 2024, revealed “...stable...means that no material deterioration of the individual’s condition is likely, within a reasonable medical probability, to result from or occur during the transfer of the individual...” Patient #3, a 62 year old male, arrived at the emergency department (Campus 2) on 06/07/2025 at 1415 via ambulance. Review of the ED Care Timeline at 1441 revealed “...ED Triage Notes BIBA (brought in by family) from home, ... with a chief complaint of blurred vision (reports vision changes yesterday followed by dizziness and generalized weakness, reports headache and abdominal pain), daughter reports he started feeling dizzy and seeing specks yesterday, then told his wife noticed his “face dropped” vomiting began about 1 hour age ago, notified named physician assistant at 1440, in triage to evaluate 1441. Not code stroke 1446. Acuity level 3.” Review of “ED Provider Note...” by Provider #1, date of service 06/07/2025 at 1448, revealed patient presented to the emergency department for evaluation of dizziness. Yesterday morning patient started experiencing dizziness, headache and weakness. He was also complaining he was feeling that he was having some specks in his vision, per wife patient seemed to have some facial droop earlier today, none presently and patient denies any facial droop at any time. Began vomiting around 1 hour prior to arrival but states he was nauseated all throughout the day. .... Denies any associated numbness or tingling weakness imbalance or confusion memory loss, cough congestions chest pain shortness of breath, abdominal pain, bowel urinary symptoms lower extremity swelling or pain. Appears to be neurologically intact without any obvious neurological deficits or acute stroke symptoms, symptoms present for over 24 hours. ...On reevaluation patient says he is feeling better no longer nauseous and continues to have a headache, treated with Tylenol (pain). Patient states that he has lack of sensation in his left arm, now appears to have NIHSS (stroke scale tool) score of 1, (1 to 4- minor stroke; 5-15 moderate stroke; 6-20 moderate to severe stroke; 21-42 severe stroke) otherwise is well- appearing neurologically intact with good strength evidence hemiparesis or aphasia, communicating without any difficulty. With patients’ combination of dizziness, headaches, decrease in sensation of left arm, reported possible facial droop earlier today but patient’s wife as well as some intermittent visual change, do feel that patient needs admission for MR patient is in agreement. Discussed with named physician has accepted care for the patient at Campus 1. Transfer orders placed at 1726. Review of Registered Nurse (RN) #1 nursing assessment on 06/07/2025 at 2000 revealed the following: Hand grasp for the right as strong and left as weak. The extremity assessment revealed numbness and tingling in the left upper extremity and left lower extremity; left lower extremity less than right lower extremity, left upper extremity less than right upper extremity. The NIH stroke scale score was documented as 11. No documentation was in the record of notifying the provider of any changes in the patient’s condition. Patient #3 remained in observation status at Campus #2 awaiting transfer to Campus #1. Inpatient orders were started at 0007 on 06/08/2025 by named Hospitalist. Patient #3 was transferred to Campus 1 on 06/08/2025 at 0910 and admitted. Unable to interview RN #1, no longer employed at the facility. Interview with ED manager on 05/26/2026 at 1615 revealed, “what I do remember is she (RN #1) did notice a change in the patient ...she did not document notifying the provider of the change of condition ...this was discussed specifically with her ...changes were made with the physician orders after midnight with the stroke protocol being initiated.” Interview with the PA (Physician’s Assistant) on 05/07/2026 at 1435 revealed, “initial stroke score was 0, CT of the head was negative on reevaluation decrease left sided weakness nothing progressive stroke score of 1.. way out of active activation range- got him accepted for transfer and later in the evening the nurse conveyed weakness but was not conveyed in an urgent manner ...I didn’t go back to reassess- it was not conveyed as emergent ... didn’t have great communication ...opportunities for improvement all the way around...” In summary, no documentation a Qualified Medical Professional (QMP) was notified or re-evaluated Patient #3 after a change in the NIH stroke score was documented at 2000. Patient # 3 was not re-evaluated by a QMP for over 12 hours after staff identified this change in condition.”

“PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION CFR(s): 482.13(a)(2)(iii) At a minimum: In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. This Standard is not met as evidenced by: 33790 Based on policy reviews, medical record review, “...Ethics Initial Information Work Sheet” and staff interviews, the hospital failed to communicate and document the result of a request for an ethics consult or to provide written response to a grievance for 1 of 1 requested ethics consults reviewed. (Pt #11) The findings included: Review of a policy titled “...30.00 Organizational Ethics Statement,” effective 10/27/2023, revealed a summary statement that “It is the responsibility of every member of (system name) administration, each medical staff and each employee to act in a manner that is consistent with its organizational mission statement and supporting policies....The institution supports a comprehensive set of programs to educate its medical staff and support personnel regarding the ethical principles it affirms... .” The policy included a procedure which noted “...G. Ethics Committee The function of the Ethics Committee is to assist in the resolution of value-based conflicts which may arise in patient care and to offer guidance to caregivers, patients, and families with regard to ethical aspects of healthcare decision making. ...” Review did not reveal a procedure for how an ethics consult would be requested or a procedure to determine if a consult was indicated. Review of the “Patient Complaint and Grievance Management Policy”, approval date 09/08/2025 revealed “... Grievances Complaints meeting any of the following criteria are considered a grievance and require a written response....1. A written or verbal complaint that cannot be resolved at the time of the complaint by staff present and requires further investigation and/or related actions for resolution.... 2. Complaints regarding the patient’s care or with the allegation of.... patient harm... .” Review of a document titled “(Hospital name) Ethics Consultation Sub-Committee Initial Information Work Sheet” revealed it was initiated by Patient #11 and family on 03/16/2026. The form stated “REASON FOR CONSULTATION...Which Medical Ethics Principles does the person/discipline who initiated the consult believe is/are broken...” There were 4 boxes on the form, one each for “Autonomy”, “Beneficence”, “Non-maleficence” and “Justice.” Each of the boxes were checked and a comment indicated “Patient/spouse were not listened to prior to delivery....Patient requested multiple times to have baby via cesarean, physician refused patient’s requests. Condition of patient and birth outcome was preventable.” Review revealed a Chaplain signed the work sheet. The work sheet indicated the “Date and time of hand off to ETHICS CONSULTATION REPRESENTATIVE” was hand recorded as “3/16 4:25pm” and it was signed in the box labeled “ETHICS CONSULTATION REPRESENTATIVE.” Medical record review for Patient #11 revealed the obstetrics patient arrived to Labor and Delivery on 03/14/2026 and delivered via cesarean section on 03/15/2026. A complication of shoulder dystocia (obstetric emergency where the shoulder gets stuck and in the mother’s pelvis) occurred during birth and despite efforts the infant did not survive. On 03/16/2026 at 1700, a “Spiritual Care Progress Note” by Chaplain #1 documented “Family request to be seen for ethics consult. Chaplain completed the form and informed family. ...” Request for a grievance letter or notification of follow-up from the request for ethics consult did not reveal a letter or written response to the patient’s concerns and ethics request. Interview with Director #3, on 05/06/2026 at 1635, revealed the Director spoke with the patient and family frequently while they were in the hospital and heard and addressed all concerns raised. Interview with Chaplain #1, a Chaplain Resident, on 05/07/2026 at 1359, revealed the Chaplain went to speak with Patient #11 and family. Interview revealed they wanted to speak with someone about what happened. Chaplain #1 stated there was a patient advocate in the Emergency Department, so Chaplain #1 reached out to that advocate. The advocate came and spoke with the family and told them she would follow-up and speak with the Nursing Manager. Interview revealed the family also asked about possible “committees” in the hospital and the Chaplain shared about the Ethics Committee and that there was a form that would need to be filled out. The Chaplain showed the family the form (Ethics Consultation Work Sheet). The patient and family looked at the form and indicated the principles they thought were violated and the Chaplain filled out the form in their presence regarding their concerns. Then, per interview, Chaplain #1 turned the form in to the Chaplain #2 (who signed the form as Ethics Consultation Representative). Chaplain #1 continued to see the patient/family and stated they thought that follow-up from Ethics would still be coming. Interview with Chaplain #2, also on 05/07/2026 at 1359, revealed Chaplain #2 did not speak with the patient or family. Interview revealed Chaplain #2 spoke with the Perinatal Services Director and in review they did not find a concern with breaking the four ethical principles and stated their concerns were already being addressed. Chaplain #2 stated when she went to speak with the patient/family the patient had already been discharged. Interview revealed no further attempts at contact occurred. Interview revealed there was no documentation related to the ethics request and consult because “...once (patients) are discharged .... don’t open the chart again.” Interview revealed there was no follow-up with the patient or family regarding the request for an ethics consult. NC00234621, NC00234965, NC00236184, NC00236483, and NC00232111.”

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 39307 Based on review of policy and procedure, observations, departmental logs and staff interview the staff failed to ensure the Cooling.Chilling Temperature was as per policy, Weekly High Temperature Mechanical Ware Washing Machine was maintained as intended daily and the Sanitizer Solution Dispenser was maintained as per policy. Findings included: Review on 04/23/2025 of the hospital policy and procedure for HACCP - COOLING/CHILLING TEMPERATURE LOG revision date, 08/15/2022 revealed “Instructions: Use this log to record cooked time/temperature controlled for safety food (TCS [Time/Temperature Control for Safety] food) that is cooling and prepared TCS foods that are chilling prior to service ...(2) Date: Document the date of the food being cooled/chilled (3) Food item: Document the name of the food being cooled/chilled ...(5) Time food started chilling: Document the time the food started chilling (6) Temp food started chilling: Document the temperature of the food when it started chilling ...” 1. Observation on 04/23/2025 at 0915 during tour of the hospital kitchen area Cooler 1 with the Director of Food & Dietetic Department and Executive Chef revealed a small pan covered with plastic of Macaroni & cheese without label to identify food, date or time of cooked item. Cooler 1 also revealed an uncovered pan of cooked 2 large steaks cooked without label to identify food, date or time of cooked item. Interview on 04/23/2025 at 0915 with the Executive Chef revealed the daily supervisor was the staff member expected to validate the task completion for labeling food items in Cooler 1. 2. Observation on 04/23/2025 at 0915 during tour of the hospital kitchen area Cooler 2 with the Director of Food & Dietetic Department and Executive Chef revealed an opened container of Horseradish expiration date of 04/04/2025 with an open date of 03/04/2025 on the shelf available for use. Interview on 04/23/2025 at 0915 with the Executive Chef revealed the daily supervisor was the staff member expected to validate the task completion for labeling food items in Cooler 2. 3. Observation on 04/23/2025 at 0915 during tour of the hospital kitchen area Cooler 3 with the Director of Food & Dietetic Department and Executive Chef revealed an opened gallon of milk without label of open date. Interview on 04/23/2025 at 0915 with the Executive Chef revealed the daily supervisor was the staff member expected to validate the task completion for labeling food items in Cooler 3. 4. Observation on 04/23/2025 at 0915 during tour of the hospital kitchen area with the Director of Food & Dietetic Department and Executive Chef revealed the Weekly High Temperature Mechanical Ware Washing Machine Log was incomplete. The staff were expected to validate the wash temperature and final rinse temperature three times per day (breakfast, lunch and dinner). Review of the log revealed on 03/08/2025 breakfast and lunch, 03/22/2025 dinner, 03/24/2025 dinner, 03/27/2025 breakfast, lunch and dinner, 03/29/2025 lunch and dinner, 03/30/2025 dinner, 04/06/2025 dinner, 04/07/2025 dinner, 04/10/2025 breakfast and lunch, 04/11/2025 breakfast and lunch, 04/12/2025 and 04/13/2025 breakfast, lunch and dinner, 04/18/2025 dinner, and 04/20/2025 breakfast and lunch were blank for assessment of the temperature. Interview on 04/23/2025 at 0915 with the Executive Chef revealed the daily supervisor was the staff member expected to validate the task completion for the High Temperature Mechanical Ware Washing Machine Log. The staff members failed to ensure the task was completed for each expected time and date. 5. Observation on 04/23/2025 at 0915 during tour of the hospital kitchen area with the Director of Food & Dietetic Department and Executive Chef revealed the Sanitizer Solution Dispenser Log was incomplete. The staff were expected to validate the sanitizing solution had reached an acceptable temperature above 65 degrees Fahrenheit (a measurement scale of temperature) daily. Review of the log revealed on 03/19/2025, 03/20/2025, 04/10/2025, 04/11/2025, 04/12/2025, 04/13/2025, and 04/20/2025 were blank for assessment of the temperature. Interview on 04/23/2025 at 0915 with the Executive Chef revealed the daily supervisor was the staff member expected to validate the task completion for the Sanitizer Solution Dispenser Log. The staff members failed to ensure the task was completed for each expected time and date. NC00227913, NC00225684”