Fmc - Neomedica - Melrose Park

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 34411 Based on document review, observation, and interview, for 2 patients (Pt #13, Pt #15) observed during hemodialysis treatments, the Facility failed to ensure that the patients’ face was visible during treatment to allow for adequate monitoring/safety. Findings include: 1. The Facility’s policy titled, “Patient Assessment and Monitoring” (dated 5/1/2023), was reviewed, and required, “The purpose of this policy is to provide guidance to [Clinic] direct care staff on assessment and monitoring patients before, during, and after treatment...All patients must be under visual observation by clinical staff during treatment...Patients may not wear sunglasses or sleeping masks without proper medical documentation confirming photosensitivity condition. These products may obscure observation of patient’s eyes. For patients’ safety, staff must ask patients to lift or remove any medically justified eye covering during each 30-minute check in order to visually confirm alertness...” 2. On 8/18/2025 between 9:20 AM-11:30 AM, an observational tour of the dialysis treatment floor was conducted. During the tour at 10:03 AM, Pt #13 was noted with dark sunglasses on during the hemodialysis treatment. Staff (E#2/registered nurse, E #3/patient care technician) attended Pt #13’s chairside at 10:05 AM, 10:30 AM, and 10:54 AM. E #2 and E #3 did not advise Pt #13 to remove the sunglasses when at the chairside. 3. On 8/19/2025 at 8:55 AM, an additional tour of the dialysis treatment floor was conducted. During the tour at 8:55 AM, Pt #15 was noted with dark sunglasses on during the hemodialysis treatment. At 9:00 AM, the registered nurse (E #5), charted at Pt #15’s chairside. E #5 did not advise Pt #15 to remove the sunglasses when at the chairside. 4. On 8/18/2025 at 10:55 AM, an interview was conducted with the Registered Nurse (E #2). E #2 stated that if patients have on sunglasses due to medical reasons, then we need to have them take them off at the 30 minute assessment time. E #2 reviewed Pt #13’s medical record and confirmed that Pt #13 did not have medical documentation to wear the sunglasses. 5. On 8/20/2025 at 2:15 PM, an interview was conducted with the Medical Director (MD #1). MD #1 stated that the patient’s face should be visible during the treatment. MD #1 stated that if a patient has photosensitivity or any other medical reason to wear sunglasses during treatment, then it should be documented.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 34411 Based on document review and interview, for 3 of 7 (Pt #5, Pt #7, Pt #14) clinical records reviewed for laboratory monitoring, the Facility failed to evaluate the appropriateness of the hemodialysis prescription, by not notifying the physician of abnormal values. Findings include: 1. The Facility’s policy titled, “Medical Record Documentation Standards” (dated 2/5/2024), was reviewed and required, “...All treatment information, treatment related events, changes in a patient’s condition or significant care issues must be noted and charted. Documentation must include follow-through. If physician notification is required, all such communication (including attempts at notification) should be charted...” 2. The Job Description for the Registered Nurse (dated 8/1/23) was reviewed and included, “Functions as part of the hemodialysis health care team as a Staff Registered Nurse to ensure provision on a daily basis accordance with [Facility] policies, procedures, and training...Educates patients regarding laboratory values and the relationship to adequate dialysis therapy...Reports alert/panic and abnormal lab results to the appropriate physician...” 3. The clinical record for Pt #5 was reviewed on 8/19/2025. Pt #5 was admitted on 10/17/2022, with a diagnosis of ESRD (end stage renal disease). The laboratory results were reviewed and included elevated potassium (mineral and electrolyte that helps muscles that control your heartbeat) laboratory results on: - 7/21/2025: 6.5 m/Eq/L high (milliequivalents per liter): normal reference range: 3.5-5.1. The clinical record lacked documentation of the registered nurse notifying the physician of the abnormal laboratory value on 7/21/2025. 4. The clinical record for Pt #7 was reviewed on 8/19/2025. Pt #7 was admitted on 2/11/2025, with a diagnosis of ESRD. The laboratory results were reviewed and included elevated potassium laboratory results on: -8/7/2025: 6.2 m/Eq/L (high) The clinical record lacked documentation of the registered nurse notifying the physician of the abnormal laboratory value on 8/7/2025. 5. The clinical record for Pt #14 was reviewed on 8/19/2025. Pt #14 was admitted on 5/22/2024 with a diagnosis of ESRD. The laboratory results were reviewed and included elevated potassium laboratory results on: - 6/16/2025: 6.0 m/Eq/L - 7/21/2025: 6.0 m/Eq/L The clinical record lacked documentation of the registered nurse notifying the physician of the abnormal laboratory value on 6/16/2025 and 7/21/2025. 6. On 8/19/2025 at approximately 9:15 AM, an interview was conducted with the Registered Dietician (E #4). E #4 stated that monitoring patient’s labs is a very important part of the dialysis treatment. E #4 stated that if labs are out of range, the nurse will contact the doctor for any new orders related to the dialysis prescription. 7. On 8/19/2025 at approximately 9:40 AM, an interview was conducted with the Clinical Nurse Manager (E #1). E#1 stated that nurses should contact the doctor when they receive panic alerts from the (outside lab company). E #1 stated that if a patient’s potassium level is greater than 6.0 m/Eq/L, the nurse should let the doctor know to see if there should be a hemodialysis prescription change or medication ordered. 8. On 8/20/2025 at 2:15 PM, an interview was conducted with the Medical Director (MD #1). MD #1 stated that MD #1 expects nurses to contact MD #1 for potassium levels greater than 6.0 m/Eq/L.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 34411 Based on document review, observation and interview, it was determined that for 5 of 6 (Pt #8-Pt #12) patients observed during the discontinuation of arteriovenous/venous fistula (AVF) sites, the Medical Director failed to ensure that staff adhered to patient care policies regarding needle removal. Finding include: 1. The Facility’s policy titled, “Post Treatment Fistula Needle Removal” (dated 7/7/2025) was reviewed, and required, “Incorrect needle removal technique can result in difficulty achieving hemostasis [stopping of active bleeding], potential injury to the access...Follow the steps below to remove the arterial and venous needles...It is optimal to remove one needle at a time and have the patient hold pressure until hemostasis is achieved. Note: If both needles are removed at the same time, pull second needle after bleeding from first needle has slowed down enough to allow adequate compression on both sites...” 2. On 8/18/2025 between 9:20 AM-11:30 AM, an observational tour of the dialysis treatment floor was conducted. During the tour, the following observations were made of patients with AVF’s, during discontinuation of treatment. - At 9:40 AM, Pt #8 was holding both AVF sites - At 9:42 AM, Pt #9 was holding both AVF sites - At 10:40 AM, Pt #10 was holding both AVF sites - At 10:47 AM, Pt #11 was holding both AVF sites - At 11:50 AM, Pt #12 was holding both AVF sites. For Pts #8-Pt #12, the patients were observed applying pressure to their 1st access site, with gauze, after the 1st needle was removed. The staff then removed the 2nd needle without checking to see if the 1st access site stopped bleeding (achieved hemostasis). 3. On 8/18/2025 at 12:50 PM, an interview was conducted with the Patient Care Technician (E #8). E #8 stated that it is policy to pull one needle at a time to be able to watch the patient’s bleeding and to preserve the access. E #8 stated that a lot of the patient’s request that both needles are pulled at the same time, so that they can leave the clinic quicker. 4. On 8/20/2025 at 2:15 PM, an interview was conducted with the Medical Director (MD #1). MD #1 stated that staff are expected to adhere to the facility’s policies. MD #1 stated that pulling one needle at a time is important so that the patient’s bleeding at the site can be monitored and to ensure that hemostasis was obtained before pulling the second needle.”