Memorial Hospital of South Bend

“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: 14445 Based on document review and interview, nursing services failed to follow their policy for Emergency Department reassessments of patient vital signs for 1 of 10 MRs (Medical Records) reviewed (Patient # 8). Findings include: 1. Facility policy titled: Documentation and Care of Beacon Health System Emergency Department patients, policy number: none listed, indicated on page 3, under POLICY/PROCEDURE, 15. b. Vital signs are documented every 4 hours or more frequently if the patient’s condition warrants, and on page 4, 21. All patients who are acuities 1, 2 or 3 will have VS (vital signs) reassessed immediately prior to departure and documented. Last revised 1/2024. 2. Review of Patient # 8 MR, indicated, the following: (a). Patient presented to the ED/ER (Emergency Department/Emergency Room) on 7/24/2026 at 6:09 pm, with complaints of diarrhea. (b). Triage note at 6:12 pm, by S # 11 (ER Triage Nurse), reflected patient Acuity = 3. (c). Patient discharged at 3:42 am (7/25/2026). Total length of stay = approximately 9 hours & 33 minutes. (d). MR lacked documentation for any vital sign reassessment(s) or vital signs obtained prior to discharge. 3. In interview on 8/19/2026 at approximately 2:10 pm, with A # 2 (ECC/Emergency Care Center Quality Manager), indicated the following: a. Verified only 1 set of vitals in MR for patient # 14, for ER visit. b. Patient # 8 should have had more than one set of vital signs. c. Staff did not follow policy for vital signs - for reassessment. 4. In interview on 8/19/2026 at approximately 4:24 pm (via phone), with S # 10 (ER Nurse), indicated the following: a. Vital signs to be checked every 4 hours. Vitals to be checked before discharge. b. Ultimately up to nurse for responsibility.”

“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: 35731 Based on document review, observation and interview, the facility failed to ensure nursing personnel were educated related to the new blood administration policy in 45 instances. The cumulative effects of these systemic problems resulted in the hospital’s inability to implement an effective quality assessment and performance improvement program.”

“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: 35731 Based on document review, observation, and interview the facility failed to ensure NICU (Neonatal Intensive Care Unit) and Neonatal staff members were educated in forty-five (45) instances related to blood compatability. (N # 50 through N # 95) Findings include: 1. The hospital policy titled, Blood Product Administration in the NICU (Neonatal Intensive Care Unit), Category/Source - 7.0 NICU: Blood Products, indicated on page three (3) - section - Points To Be Emphasized - number five (5) - All blood products should be checked carefully to prevent reactions due to incorrect infusions. This policy was last revised on 07/19/2023. 2. The hospital policy titled, Incident Reporting Policy, Category/Source - Risk Management, indicated on page four (4) - section - six (6) - Incident Reporting Follow Up - letter C - Opportunities for Improvement/Learning - Managers/Directors will use the electronic incident system data to provide reports to identify incident prevalent trends and areas that may need improvement. Trend and improvement information may be shared with staff for learning opportunities. This policy was last revised in 04/2019. 3. The hospital policy titled, Analysis of Patient Safety Events, Category/Source: BHS Risk Management, indicated on page two (2) - section - Root Cause Analysis (RCA) Process - number five (5) - An action plan will be developed that identifies strategies to be implemented that intend to reduce the risk of similar incidents occurring in the future - number seven (7) - Action plans should be completed within 45 day for reportable events and 90 days for non-reportable events. This policy was last revised on 02/01/2024. 4. Review of the - Action Item - RCA - Consider badge buddy or some other educational method for nurses to understand compatibility issues - due date 11/30/2025 - measure of success - Badge buddies were created and distributed to all Registered Nurses and laboratory staff. 5. Review of the education sheet for the Neonatal Intensive Care & Neonatal Staff - Updated 11/24/2025 - By initialing next to my name, I have read the revised Blood Product Administration in the NICU policy - Total Nurses - Signed were Forty (40) - Not Signed - Forty-five (45). 6. Review of patient # 10’s MR indicated the patient received O - (negative) FFP (fresh frozen plasma) in route to H # 3 (Pediatric Hospital) by N # 6 (Charge Registered Nurse-RN/NICU) 7. During observation on 05/06/2026 - NICU - one (1) of two (2) RNs were not wearing the badge buddy related to compatible blood products. 8. In interview on 05/06/2026 at approximately 1:16 pm with nursing staff members N # 3 (Registered Nurse-RN/NICU) and N # 4 (RN/NICU), confirmed they were not aware of any education related to blood product administration. 9. In interview on 05/06/2026 at approximately 1:45 pm with laboratory staff member L # 2 (Senior Medical Laboratory Scientist), confirmed universal FFP would be type AB not O - (negative). 10. In interview on 05/06/2026 at approximately 3:10 pm with administrative staff member A # 4 (Director for Women & Children), confirmed they had a safety meeting which happens for serious events so we can do a deeper dive into the investigation and figure out the lack of process and then we do action items. The education process was started with the NICU previous manager and the unit educator. All the nurses on the NICU and Neonatal Unit should have been educated related to the incident and were not. 11. In interview on 05/07/2026 at approximately 11:00 am with nursing staff member N # 6, confirmed the patient # 10 received O - (negative) fresh frozen plasma in route to H # 3 (Pediatric Hospital).”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 35731 Based on document review and interview the registered nurse failed to ensure the right blood product was for the right patient in one (1) of ten (10) patient medical records (MRs) reviewed. (Patient # 10) Findings include: 1. The hospital policy titled, Blood Transfusion, Including Blood Components, Category/Source 08.0 Patient Care, indicated on page one (1) - section - Delegation - Requires a Registered Nurse (RN) to serve as one of the two transfusionists who must ensure correct identification of the patient and blood product. This policy was last revised on 12/1/2024. 2. Review of the hospital Event Detail History - Occurred On - 10/12/2025 - Test-202928 - indicated patient # 10 was type A + (positive) and received type O - (negative) FFP (Fresh Frozen Plasma). 3. Review of patient # 10’s MR indicated the following: a. Emergency Release Request - no date, no signature, indicated two (2) units of O negative FFP was dispensed to N # 5 (RN) for patient # 10. b. Transport (Air and Ground) - response number 490226 - page one (1) - Specialty Care Transport - Emergent - Position of patient - Isolette - page two (2) - Crew Members - N # 6 (RN) and NP # 1 (Nurse Practitioner-NP) - page three (3) - Narrative - During transport patient # 10 required fluid resuscitation which included normal saline and FFP - page four (4) - 0640 hours - Blood Product - vitals completed - 0640 hours - Transfusion of fresh frozen plasma (procedure) - dosage 20 ml (milliliters) - Route - Intravenous (IV) - page six (6) - Blood Product - vitals completed - 0755 hours - Transfusion of fresh frozen plasma (procedure) - dosage 20 ml - Route - IV - Comment - Infusing upon arrival at H # 3 (Children’s Hospital) - Neonatal Intensive Care Unit (NICU). 4. In interview on 05/06/2026 at approximately 1:45 pm with laboratory staff member L # 2 (Senior Medical Laboratory Scientist), confirmed universal FFP would be type AB not O - (negative). 5. In interview on 05/07/2026 at approximately 11:00 am with nursing staff member N # 6, confirmed the patient # 10 received O - (negative) fresh frozen plasma in route to H # 3 (Pediatric Hospital).”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 14445 Based on document review and interview the facility failed to ensure an appropriate transfer for 1 of 20 ED/ER (Emergency Department/Emergency Room) MRs (Medical Record) reviewed. (Patient # 17). Findings include: 1. Facility policy titled: EMTALA Treatment and Transfer of Individuals Who Request Emergency Services, policy number: none listed, indicated on page 3, K. Transfer means movement of an individual outside the hospital; on page 6, under D. Individuals who do not have an Emergency Medical Condition, 1. If a qualified medical person determines, as a result of a medical screening examination, that the individual does not have an emergency medical condition, the individual may be transferred to another healthcare facility (if in need of further care); shall be in accordance with the hospital’s transfer procedure; 2. Appropriate transfer forms will be completed if the patient is transferred to another facility; on page 11, under 5. The transferring hospital must send to the receiving hospital appropriate medical records, treatment provided, written informed consent for transfer, and on page 13, under Explanation of Forms, 4. Transfer Information form documents information necessary for implementing an appropriate transfer. Last reviewed 7/2024. 2. Review of MR # 17 for AH # 40, indicated the following: (a). Nurse note on 3/13/2025 at 9:06 pm, by N # 20 (RN/Registered Nurse - SANE (Sexual Assault Nurse Examiner) reflected N # 20 introduced self and explained her/his role as a SANE nurse. Patient told this RN (Registered Nurse) that she took a bus and walked here to be evaluated for sexual assault. Patient states that she/he was raped by FM # 1’s (Family Member) friend last night while she/he was sleeping. Patient states that she/he was in and out of it during sleep and does not recall any details of the event. Patient denies any vaginal pain or discharge. Patient states that she/he did change clothes; but has not had a shower in a few weeks. (b). ER provider note on 3/13/2025 at 9:47 pm, by MD # 30 (Doctor of Medicine/MD-ER/ED Staff) reflected chief complaint SA (sexual assault). Patient came to ER stating that she/he was raped last night in a tent. Patient does have some vaginal soreness. Denies any other complaints such as bruising or chest pain or injury. Patient decided to come to ER at 8:30 pm. Chose AH # 40 (Acute Care Hospital) since she/he could walk here. Physical exam completed. Patient alert & oriented, no distress. Medical decision making: includes possible sexual assault. At this time patient is requesting to go to AH # 41 (Acute Care Hospital) where there is a SANE (Sexual Assault Nurse Examiner) program. Patient was offered treatment here however she/he wants to go to AH # 41. At this time she/he is medically cleared and will be released. MD # 30 was told that the police will take patient to AH # 41 from AH # 40. Once again she/he was offered treatment here; she/he would like to go to AH # 41. Disposition: Patient released with the police to go to AH # 41. Discharge diagnosis will be reported sexual assault. (c). Nurse note on 3/13/2025 at 10:25 pm, by N # 20 reflected patient given discharge instructions. Patient informed that local police has been dispatched and should be coming to take statement and transport patient to AH # 41 at patient’s request; as she/he wants to be seen by AH # 41’s forensic department. (d). The MR lacked required documentation for an appropriate transfer to AH # 41. Lacked completed transfer form; no communication with AH # 41’s ED/ER staff by ED/ER staff at AH # 40 for patient’s request & patient transfer. 3. Review of MR # 17 for AH # 41, indicated the following: (a). ER/ED MD - provider note on 3/14/2025 at 12:00 am, reflected patient presents to ED for safe evaluation. Was a victim of a sexual assault, this occurred down near theater in the city. She/he was assaulted by a homeless individual; she/he - herself/himself is homeless. Was brought in by local police. Had been previously evaluated at AH # 40. ROS (review of systems) and physical exam completed. Patient was seen and evaluated by SANE nurse. Patient was sexually assaulted in the city. Patient stable for discharge. It has been determined that the patient is safe. The SANE nurse determined that the patient was safe for discharge. Results and plan of care discussed with patient. 4. In interview on 4/8/2025 at approximately 10:22 am, with A # 3 (Director ED), confirmed the following: a. AH # 41 has a full program - wrap around program with community services and follow-up visits for patients/victims of sexual assault/alleged sexual assault. b. Did not consider as a transfer; patient # 17 was stable, discharged. Patient wanted to go to AH # 41. 5. In interview on 4/8/2025 at approximately 10:25 am, at approximately 12:30 pm, and at approximately 5:30 pm, with A # 4 (ED Manager - SANE Nurse), confirmed the following: a. Sounds familiar; recent patient to different hospital with SANE program. b. There was no courtesy call to AH # 41; nurse to nurse; for patient (Patient # 17) going over to AH # 41. 6. In interview on 4/8/2025 at approximately 6:15 pm, with N # 20 (RN/Registered Nurse - SANE (Sexual Assault Nurse Examiner), confirmed the following: a. Patient # 17 stated sexually assaulted, when presented to ER. Patient was triaged, received MSE by MD # 30. b. N # 20 informed patient # 17 that was a SANE trained nurse; could do kit, screening for STIs (sexually transmitted infection), speak with social worker, could call law enforcement and could provide prophylaxis medications. Patient asked is that all. Informed patient more resources in community available through SANE program - Forensic department at AH # 41. Patient stated would like to go to AH # 41. N # 20 let MD # 30 know about patient wanting to go to AH # 41. d. Local police called; as patient # 17 wanted to give statement. Patient asked if they could provide transportation, as she/he walked here. Police agreed to give patient ride to AH # 41.”