Concerto Wisconsin LLC

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 29972 Based on record review and interview the facility staff failed to ensure there was a functional environment with working equipment in 2 of 2 staff interviews (Registered Nurse (RN) C, Regional Manager (RM) B), in a total of 2 staff interviews. Findings Include: Review of policy and procedure #CRS-1200-016 titled, “Physical Plant” origination dated 12/2021 revealed, “All equipment in the dialysis facility and dialysis equipment must be maintained in safe and functional working condition.” Review of the Home Dialysis Coordination Agreement effective 01/01/2023 (contract between dialysis facility and nursing home) revealed the following: 1. Section 3.2 Ancillary Needs: “(Nursing home) shall provide the following: (a) Utility, Maintenance, and Cleaning: All necessary utility, maintenance, and cleaning associated with Dialysis Services provided in the Dialysis Unit, including but not limited to access to the (nursing home’s) Internet network, so that it is adequate for (dialysis facility) use.” 2. Section 3.5 “Maintenance of the Dialysis Unit: (Nursing home) shall keep all equipment used by (dialysis facility) within the Dialysis Unit that has not been provided by (dialysis facility) in good working order at all times.” Per telephone interview with RN C on 04/09/2024 beginning at 12:45 PM, on 03/08/2024, nursing home staff transferred Pt #1 to the dialysis chair, disconnected Pt #1 from his/her personal O2 concentrator and placed the concentrator on the shelf above Pt #1’s dialysis chair. RN C stated that the O2 concentrator fell off the shelf and on to Pt #1’s head. Per RN C, the incident may have occurred due to Pt #1 tapping/moving the TV/TV arm (to get the TV signal to work) which was attached to the shelving unit where the O2 concentrator was being stored. RN C stated it was common for the TV signal to go in and out and for patient’s to tap and move the TV to get it to work. RN C stated that dialysis staff have not informed the nursing home of the issue with the TVs in the dialysis room losing the WIFI signal. Per interview with Regional Manager (RM) B on 04/09/2024 beginning at 1:15 PM, RM B stated that sometimes the TVs in the dialysis room go in and out and the Pts may move and tap the TV hoping it will make the TV work; per RM B it is typically a WIFI signal issue. RM B stated that the nursing home is responsible for TV issues and that dialysis staff should submit a maintenance request to the nursing home. RM B is not aware of a maintenance request being submitted for the TV signal issue.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 29972 Based on record review and interview the facility staff failed to perform a root cause analysis, develop and implement a corrective action plan, and monitor the plan for effectiveness in 1 of 1 adverse events reviewed (Patient (Pt) #1), in a total sample of 1 adverse event reviewed. Findings Include: Review of policy and procedure #CRS-100-009 titled, “Adverse Occurrence Reporting” dated 01/2018 revealed, “At any time that staff fails to adhere to clinical policy and procedure, a serious or unexpected adverse event occurs on behalf of the facility, staff, and/or patient or there is an unexpected equipment event, staff will be responsible for: Documenting the adverse event electronically in the confidential...Adverse Occurrence (AOR) form...Notifying management...Notifying the patient’s Nephrologist (kidney doctor)...Perform a Root Cause Analysis (RCA)...” Review of the Home Dialysis Coordination Agreement effective 01/01/2023 (contract between dialysis facility and nursing home) revealed the following: 1. Section 3.4 “Transportation to and from the Dialysis Unit: (nursing home) staff shall be responsible for timely transporting each Resident receiving Dialysis Services to and from the chair within the Dialysis Unit, in accordance with the dialysis schedule (dialysis facility) presents to the (nursing home).” 2. Section 3.6 “Communication: (dialysis facility) and (nursing home) staff must communicate regularly through defined and systematic processes. (nursing home) staff shall inform (dialysis) staff of any event occurring after a Resident’s treatment that may affect future administration of Dialysis Services to that Resident. In addition, (nursing home) shall immediately inform (dialysis facility) of any changes in the Resident’s medical condition relating to continued Dialysis Services. (Nursing home) staff shall participate in and have ultimate responsibility for Resident care planning.” 3. Section 4.3 Purpose: “It is critical that both Parties work cooperatively with Residents, their families, their physicians, and each other in order to achieve quality results of the Dialysis Services provided under this Agreement. Therefore, (dialysis facility) and (nursing home) agree to coordinate their respective services, as set forth herein.” 4. Section 4.4 Duties of (dialysis facility): “(dialysis facility) shall: (r) Incorporate the services provided to (nursing home) Residents into (dialysis facility’s) Quality Assessment and Performance Improvement (QAPI) program; when issues or negative trends are identified by the QAPI program, (dialysis facility) will report them to the (nursing home) in an effort to develop, implement and follow-up on corrective actions to resolve the issues and improve performance.” Review of Pt #1’s HD (Hemodialysis) Treatment Flowsheet dated 03/08/2024 revealed that Registered Nurse (RN) C documented the following: At 6:47 AM: “O2 (oxygen) concentrator fell off shelf on to patient head, pt alert.” At 7:01 AM: “Applied ice to forehead, pt awake and talking with staff.” At 7:04 AM: “Treatment terminated due to incident.” At 7:30 AM: “Sending pt out vial Bell ambulance.” Review of Pt #1’s Treatment Flowsheet dated 03/08/2024, revealed there was no documentation of RN C notifying or attempting to notify the Provider. Review of Pt #1’s AOR dated 03/08/2024 revealed at 6:40 AM, “(Pt #1) was reclined back watching TV in (Pt #1’s) dialysis chair when (Pt #1’s) portable O2 concentrator from the nursing home fell off the shelf on to the left side of (Pt #1’s) forehead...(RN C) went over to (Pt #1’s) chair and removed the O2 machine, placing it on the floor. the patient stated, it hurts on my left side, it scared me. I have an aneurysm on that side (referring to left side of head)...(RN C) took a blood pressure and observed the area of pain. (RN C) asked if patient would like to go to hospital for additional observation. (RN C) applied ice, called the SNF (skilled nursing facility) staff...informed them of the incident and called ambulance....The patient remained alert and oriented. No loss of mentation.” Review of training log completed by the nursing home staff dated 03/08/2024, revealed signatures from nursing home staff (certified nursing assistants) acknowledging they were informed not to place the O2 concentrator on the shelf above patients head but on the dialysis chair. Per telephone interview with RN C on 04/09/2024 beginning at 12:45 PM, RN C stated that nursing home staff (certified nursing assistants--CNA) bring the patients into the dialysis room for treatment and assist with transferring patients to the dialysis chair (dialysis room located inside the nursing home). Per RN C the nursing home staff disconnect patients from their personal O2 concentrator and then connect patients to the oxygen concentrator located in the dialysis room (if O2 is needed). Per RN C, on the day of the incident, nursing home staff transferred Pt #1 to the dialysis chair, disconnected Pt #1 from his/her personal O2 concentrator and placed the concentrator on the shelf above Pt #1’s dialysis chair. RN C stated that prior to Pt #1’s incident, Pt #1’s personal O2 concentrator was usually placed on the floor near the chair, hung on the arm rest (if in the black carrier), or placed on the shelf behind/above Pt #1’s chair. RN C stated that she/he was unable to notify the Provider after the incident because there was no answer when RN C called the Provider line (1-800 number); RN C stated that the Provider was not informed the day of the incident (Per RN C the Provider was eventually informed but RN C was unsure of the exact date). RN C stated that she/he was unaware if the dialysis staff completed a formal investigation into the incident, but RN C stated that no one from the dialysis facility interviewed RN C about the incident. RN C stated that the Director of Nursing at the nursing home came to speak with RN C about how the dialysis staff should handle the O2 concentrators; RN C was not sure if any formal education was provided to the nursing home staff who assist patients to the dialysis chairs. RN C stated that after the incident staff (dialysis & nursing home staff) no longer place the O2 concentrators on the shelf behind the patients. RN C denied audits being conducted to monitor compliance. RN C stated that the issue with the TV’s losing signal has not been addressed with the nursing home. Per interview with Regional Manager (RM) B on 04/09/2024 beginning at 1:15 PM, RM B stated that RN C called to inform RM B of the incident on the day of occurrence. RM B stated she/he thought RN C notified the Provider and was not aware this did not occur. RM B stated the Provider should have been notified as soon as possible after the incident occurred. RM B stated that there was no documented evidence of a formal investigation into the incident (including determining root cause, developing a action plan, documentation of staff education, and follow up). RM B stated that she/he was not aware if the nursing home staff developed a corrective action plan after the incident, and RM B did not follow up with nursing home to ensure CNA staff were educated about personal O2 concentrators not being placed on the shelf behind the Pts (as per above, education was provided to the nursing home CNAs). Per RM B after the incident, dialysis staff were told to ensure personal O2 concentrators were placed on the ground and not on the shelf behind the patient’s chair. RM B stated that the dialysis staff have not performed monitoring/audits to ensure ongoing compliance. Per interviews with RN C and RM B, there is a lack of communication with the nursing home to ensure the development of a collaborative investigation/root cause analysis, corrective action plan, and follow up (as per their contractual agreement).”