Fmc-Indianapolis Northeast

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 51279 Based on record review and interview, the facility failed to evidence proper documentation and tracking of an adverse event for 1 of 1 active clinical records reviewed with a patient reporting an adverse event (Patient #2). Findings Include: 1. Review of a facility policy dated 11/04/2024 titled “ Quality Assessment and Performance Improvement Program” indicated but is not limited to, “ ... The program must reflect the complexity of the organization and services and must focus on indicators related to improved patient health outcomes and the prevention and reduction of medical errors ... QAPI is a continuous ongoing process that includes monitoring the data ... Elements to be reviewed will include: ... Patient Safety ...” 2. Review of a facility policy dated 02/06/2023 titled “Patient Safety Event Reporting and Documentation” indicated but is not limited to, “ ... When a Near Miss, Safety Event or Serious Safety Event occurs, staff are required to report, document, and review the event as noted in this policy ... Patient Safety Events should be reviewed during Quality Assessment and Performance Improvement (QAPI) Program ... Evaluate the safety reporting that includes category, event type and outcome ... Ensure documentation within the Patient Safety Data Entry Site has been completed ...” 3. Review of a facility document dated 07/21/2025 titled “Adverse Events Report” failed to evidence an infiltration of Patient #2’s arteriovenous access during the month of May. 4. Review of facility quality assurance meeting minutes dated 06/20/2025 evidenced the facility reviewed quality data from the month of May. The meeting minutes indicated but is not limited to, “ ... Safety- no issues ...” 5. Review of the clinical record for Patient #2 evidenced a Psychosocial Progress Note dated 05/31/2025 and signed by the MSW. The noted indicated but was not limited to, “ ... Patient did have infiltration today ...” Review of the clinical record for Patient #2 evidenced a Clinical Notes Report. The report failed to evidence documentation of the infiltration. During an interview on 07/22/2025 at 10:03 AM, Patient #2 indicated in the last month or two they infiltrated a few times. When queried what happened if there was an infiltration they indicated they continued treatment. During an interview with PCT 1 on 07/21/2025 at 2:11 PM, they explained if an incident happened they were to notify the nurse. During an interview with PCT 4 on 07/22/2025 at 1:40 PM, they indicated they followed the policy for reporting any adverse events. They indicated if an infiltration happened, it was considered an adverse event and should be reported and logged on their electronic medical record system. During an interview on 07/23/2025 at 12:54 PM, the Director of Operation (DO) 2 indicated a patient safety event or adverse event is considered the same thing. When queried what types of events are considered patient safety and should be reported, the DO 2 indicated a clotted dialyzer, blood loss, separation of systems, patient fall, cardiac event, or infiltration. When queried about the infiltration mentioned on the Psychosocial Progress Note dated 05/31/2025, the DO 2 indicated the infiltration should have been entered and recorded on the Adverse Event Log, but the event was not reported. The DO 2 indicated there was a red flag when reviewing the data, and there was no event documented. During an interview with RN 4 on 07/23/2025 at 2:35 PM, they revealed if an adverse event were to occur, they would notify the CM and document the adverse event in the electronic medical record.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 47343 Based on record review and interview the facility failed to maintain a complete and accurate medical record by not obtaining and retaining a completed Against Medical Advice (AMA) Form for 3 of 3 active clinical records reviewed (Patient # 3, 4, and 7) with patients ending treatment early. Findings Include: 1. Review of a facility policy dated 06/16/2025 titled “Early Termination or Arriving Late for Treatment” indicated but is not limited to, “ ... If a patient insists on terminating treatment early and this has not been previously approved by the patient’s provider, the patient must take full responsibility for consequences of the missed or shortened treatment ... If a patient request to leave treatment early: ... RN is responsible to notify the provider, and document on the “AMA”, or Against Medical Advice form ... 2. A review of the active clinical record for Patient #3 evidenced the current Dialysis (treatment removing excess fluid and waste from the body when the kidneys are unable to function appropriately) Prescription Order dated 07/21/2025. The order included but was not limited to, “ ... 4 hrs (sic hours) 0 min (sic minutes) ...” A review of Patient #3’s active clinical record evidenced a treatment sheet dated 06/24/2025. It indicated the treatment was initiated on 6:20 AM and ended at 9:46 AM. Patient #3’s actual treatment duration was 3 hours and 25 minutes. The document indicated the patient requested to end the treatment early and an AMA form was completed. A review of Patient #3’s active clinical record evidenced a treatment sheet dated 07/05/2025. It indicated the treatment was initiated on 6:16 AM and ended at 9:29 AM. Patient #3’s actual treatment duration was 3 hours and 13 minutes. The treatment record failed to evidence why the treatment ended early. During an interview with Director of Operations 2 on 07/16/2025 at 2:40 PM, they indicated they were unable to find AMA forms for Patient #3’s treatment sheets dated 06/24/2025 and 07/05/2025. 3. A review of the active clinical record for Patient #4 evidenced the current Dialysis Prescription Order dated 07/21/2025. The order included but was not limited to, “ ... 4 hrs (sic hours) 15 min (sic minutes) ...” A review of Patient #4’s active clinical record evidenced a treatment sheet dated 07/01/2025. It indicated the treatment was initiated on 1:33 PM and ended at 4:47 PM. Patient #4’s actual treatment duration was 3 hours and 14 minutes. The treatment record evidenced the patient requested to end the treatment early due to foot pain. During an interview the Director of Operations 2 and Clinical Manager on 07/16/2025 at 12:55 PM, they indicated they were unable to find the AMA form completed for Patient #4’s treatment sheet dated 07/01/2025. 51279 4. Review of the clinical record for Patient # 7 evidenced a dialysis order dated 07/21/2025, for a prescribed treatment duration time of 4 hours and 45 minutes. A review of the treatment flowsheet dated 07/11/2025 evidenced a prescribed treatment duration of 4 hours and 45 minutes. The treatment flowsheet indicated the actual duration of dialysis treatment for 3 hours and 44 minutes. The treatment flowsheet failed to indicate why Patient #7 terminated treatment early. The clinical record for Patient #7 failed to evidence an Against Medical Advice form. During an interview on 07/23/2025 at 9:03 AM, the Clinical Manager confirmed the facility was unable to locate the Against Medical Advice form for Patient #7. 5. During an interview with Director of Operations 2 on 07/16/2025 at 12:06 PM, they explained if the patient terminated the treatment early, an AMA form was to be completed, and the physician notified. 6. During an interview with PCT 4 on 07/16/2025 at 2:24 PM, they indicated an AMA form was to be completed for any reason a patient wanted to come off of their treatment early. 7. During an interview with RN 4 on 07/16/2025 at 2:35 PM, they indicated if a patient did not want to finish their dialysis treatment, an AMA form should be completed.”