Fms South Durham Dialysis Center

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 38766 Based on a review of the facility’s “Fire Drill,” policy review, Fire drill exercise documentation, and interview, the facility staff failed to ensure fire drill exercises were performed per policy. Findings included: A review on 02/13/2025, of the facility’s policy “Fire Drill” published 08/02/2017 revealed “...Fire Drills *Quarterly, all named company facilities shall perform a fire drill for each shift of patients and staff including Home Therapy patients present in the facility and Nocturnal shift. In addition to the drill, activation of the fire alarm once per staff shift shall occur to: ensure the alarm system is working and simulation of emergency fire conditions. Ensure each shift of staff working the facility is familiar with the signals and emergency action required during a fire...” A review on 02/13/2025 of the facility’s fire drill documentation from February 2024 to the present revealed no documentation of fire drill from June 2024 to December 2024. The review revealed, that the facility failed to perform fire drill exercises as per policy. An interview on 02/13/2025 at 1450 with the CM, revealed “that fire drills should be conducted every quarter. The interview revealed that the facility failed to follow the policy.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 38766 Based on policy review, observations, and staff interviews, the facility staff failed to maintain oxygen (O2) cylinders per facility policy for four (4) of eight (8) O2 cylinders observed. Findings included: A review on 02/11/2025 of the “Emergency Administration of Oxygen” published 11/01/2021 revealed “...Oxygen cylinders must be secured in an area where they will not fall... Unless in use, secondary (reserve) cylinders/tanks must be: Secured to racks or rolling stands in a storage area or dedicated area for oxygen...” An observation on 02/11/2025 between 1050 and 1300 during a tour of the treatment floor revealed that eight oxygen cylinders were stored in an area near the back exit door. The observation revealed four of the eight oxygen cylinders were sitting on the floor unsecured, and they were not kept in racks or rolling stands. An interview on 02/12/2025 at 1530 with the ATOM revealed that “the oxygen tanks were not supposed to be left unsecured on the floor. The interview revealed that the tanks needed to be kept in racks. The ATOM stated that he ordered some racks and was hoping to get them soon. The interview confirmed the findings.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 38766 Based on a review of policy and procedures, medical records review, and staff interviews, the facility staff failed to perform and/or document every 30-45-minute monitoring of patients during dialysis treatments for 6 (six) of 9 (nine) in-patient records reviewed (Patient #1, #2, #6, #7, #4, and #3). Findings included: A review on 09/10/2024 of the facility’s policy and procedure, “Patient Assessment and Monitoring” published 05/01/2023, revealed “...During Treatment Obtaining blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes per state regulations...” 1. An open medical record review on 02/13/2025 for Patient #1 revealed a 77-year-old male admitted to the facility for ICHD treatments on 11/08/2024. A review of the treatment sheet dated 01/22/2025 revealed the treatment started at 1256 and ended at 1625 (209 minutes). The treatment flowsheet revealed no documented vital signs from 1500 through 1554 (54 minutes). A review of the treatment flowsheet 01/24/2025 revealed the treatment started at 1210 and ended at 1615 (245 minutes). The treatment flowsheet revealed no documented vital signs from 1210 through 1303 (53 minutes). A review of the treatment flowsheet on 01/27/2025 revealed the treatment started at 1221 and ended at 1624 (243 minutes). The treatment flowsheet revealed no documented vital signs from 1221 through 1420 (119 minutes) and 1510 through 1615 (65 minutes). A review of the treatment flowsheet on 01/29/2025 revealed the treatment started at 1241 and ended at 1640 (239 minutes). The treatment flowsheet revealed no documented vital signs from 1330 through 1610 (160 minutes). The review revealed the facility staff failed to monitor the patient every 30 to 45 minutes during the hemodialysis treatment per the facility policy. An interview on 02/13/2025 at 1315 with the CM revealed that the PCTs should take the patient’s vital signs and safety checks every 30 to 45 minutes; however, every 30 minutes was the standard. The interview also revealed that the PCTs were expected to notify the nurse of any abnormal blood pressure and heart rate readings. The interview confirmed that the staff did not follow the policy. 2. An open medical record review on 02/13/2025 for Patient #2 revealed a 59-year-old male was admitted to the facility for ICHD treatments on 06/25/2019. A review of the treatment sheet dated 01/21/2025 revealed the treatment started at 1304 and ended at 1518 (237 minutes). The treatment flowsheet revealed no documented vital signs from 1134 through 1304 (90 minutes) and again from 1304 through 1034 through 1444 (100 minutes. The review revealed the facility staff failed to monitor the patient every 30 to 45 minutes during the hemodialysis treatment per the facility policy. An interview on 02/13/2025 at 1315 with the CM revealed that the PCTs should take the patient’s vital signs and safety checks every 30 to 45 minutes; however, every 30 minutes was the standard. The interview also revealed that the PCTs were expected to notify the nurse of any abnormal blood pressure and heart rate readings. The interview confirmed that the staff did not follow the policy. 3. An open medical record review on 02/12/2025 for Patient #6 revealed a 75-year-old female admitted to the facility for ICHD treatments on 12/06/2024. A review of the treatment sheet dated 01/27/2025 revealed the treatment started at 0701 and ended at 1058 (237 minutes). The treatment flowsheet revealed no documented vital signs from 0931 through 1058 (88 minutes). A review of the treatment sheet dated 01/29/2025 revealed the treatment started at 0649 and ended at 1035 (226 minutes). The treatment flowsheet revealed no documented vital signs from 0703 through 0802 (59 minutes) and again from 0901 through 1035 (94 minutes). The review revealed the facility staff failed to monitor the patient every 30 to 45 minutes during the hemodialysis treatment per the policy. An interview on 02/13/2025 at 1315 with the CM revealed that the PCTs should take the patient’s vital signs and safety checks every 30 to 45 minutes; however, every 30 minutes was the standard. The interview also revealed that the PCTs were expected to notify the nurse of any abnormal blood pressure and heart rate readings. The interview confirmed that the staff did not follow the policy. 4. An open medical record review on 02/13/2025 for Patient #7 revealed a 71-year-old female admitted to the facility for ICHD treatments on 04/08/2020. A review of the treatment sheet dated 01/29/2025 revealed the treatment started at 0547 and ended at 0919 (212 minutes). The treatment flowsheet revealed no documented vital signs from 0548 through 0701 (73 minutes) and again from 0804 through 0920 (76 minutes). The review revealed the facility staff failed to monitor the patient every 30 to 45 minutes during the hemodialysis treatment per the policy. An interview on 02/13/2025 at 1315 with the CM revealed that the PCTs should take the patient’s vital signs and safety checks every 30 to 45 minutes; however, every 30 minutes was the standard. The interview also revealed that the PCTs were expected to notify the nurse of any abnormal blood pressure and heart rate readings. The interview confirmed that the staff did not follow the policy. 5. An open medical record review on 02/13/2025 for Patient #4 revealed a 64-year-old female admitted to the facility for ICHD treatments on 06/29/2011. A review of the treatment sheet dated 01/31/2025 revealed the treatment started at 0650 and ended at 0951 (181 minutes). The treatment flowsheet revealed no documented vital signs from 0700 through 0804 (64 minutes). The review revealed the facility staff failed to monitor the patient every 30 to 45 minutes during the hemodialysis treatment per the policy. An interview on 02/13/2025 at 1315 with the CM revealed that the PCTs should take the patient’s vital signs and safety checks every 30 to 45 minutes; however, every 30 minutes was the standard. The interview also revealed that the PCTs were expected to notify the nurse of any abnormal blood pressure and heart rate readings. The interview confirmed that the staff did not follow the policy. 6. An open medical record review on 02/11/2025 for Patient #8 revealed an 80-year-old female admitted to the facility for ICHD treatments on 10/18/2024. A review of the treatment sheet dated 01/20/2025 revealed the treatment started at 1225 and ended at 1555 (210 minutes). The treatment flowsheet revealed no documented vital signs from 1240 through 1337 (57 minutes). The review revealed the facility staff failed to monitor the patient every 30 to 45 minutes during the hemodialysis treatment per the policy. An interview on 02/13/2025 at 1315 with the CM revealed that the PCTs should take the patient’s vital signs and safety checks every 30 to 45 minutes; however, every 30 minutes was the standard. The interview also revealed that the PCTs were expected to notify the nurse of any abnormal blood pressure and heart rate readings. The interview confirmed that the staff did not follow the policy.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 38766 Based on policies and procedures, medical record review, and staff interview, the facility staff failed to document the assessment and action taken in 1 of 9 sampled patients with elevated blood pressure readings during hemodialysis treatments (Patient #8). Findings included: A review on 02/11/2025 of the facility’s policy titled “Hypertension” published 09/07/2021 revealed, “... Treating Hypertension Follow the steps below to address hypertension: 1. Notify the nurse in charge if a patient has a systolic blood pressure greater than 180... or diastolic blood pressure greater than 100... 2. The RN will assess the patient and determine if further nursing interventions are needed... 5. Document in patient’s treatment record...” A medical record review on 02/11/2025 for Patient #8 revealed the patient was admitted to the facility on 10/18/2024 for ICHD treatment. A review of the patient’s treatment flowsheet on 01/27/2025 revealed that hemodialysis treatment was provided for the patient from 1217 - 1547 for 3 hours and 30 minutes. The review revealed the patient’s pre-treatment blood pressure was 166/91. The review revealed a BP checked at 1236, indicating a reading of 188/95 with a comment by the PCT, “BP elevated, patient asymptomatic, named RN notified.” At 1303 (27 minutes later), the PCT documented a BP of 210/93; at 1335 (32 minutes later), a BP of 191/85 with a comment “BP elevated, patient asymptomatic, named RN notified.” At 1405 (30 minutes later), the PCT documented a BP of 186/92 and made a comment that “BP elevated; patient asymptomatic RN notified.” at 1435 (30 minutes later), the PCT noted a BP of 191/75 with the comment of “BP elevated; patient asymptomatic RN notified.” 1501 (26 minutes later), the PCT reported a BP of 209/94 and a comment of “BP elevated; patient asymptomatic RN notified.” At 1533 (32 minutes later), the PCT documented a BP of 208/81 and again at 1553 (20 minutes later) a BP of 212/106. The review indicated that the patient’s blood pressure after treatment was 212/94. The review of the patient’s nursing assessment post-treatment revealed a comment that the “Pt. discharged safely into the lobby with stable vital signs.” The review failed to reveal documented evidence of the nursing assessment of the patient’s blood pressure and nursing interventions before the end of treatment. An interview on 02/13/2025 at 1315 with the CM revealed that the expectation was for the PCT to collect the patient’s vital signs, including the blood pressure and pulse, at a minimum of every 45 minutes. The interview also revealed that the nurse was responsible for assessing the patient for elevated blood pressure and administering PRN (as needed) medications when available. If necessary, the nurse should notify the physician. The interview confirmed the findings.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 38766 Based on policy review, medical records review, and staff interview, the facility staff failed to follow the adequacy plan of care by failing to dialyze patients at the prescribed treatment duration time and/or obtain a signed against medical advice (AMA) form for 2 of 9 sampled in-center hemodialysis records (Patients #6 and #7) and by failing to dialyze 2 of 9 patients at the prescribed BFR and DFR (Patients #6 and #1). Findings included: a. A review on 02/12/2025 of the policy and procedure “Early Termination or Arriving Late for Treatment” revised 11/07/2022 revealed, “...Early termination ...The RN who evaluates the patient must document the rationale for early termination and reinforce the consequences of not receiving the prescribed treatment. The RN was responsible to... document on the ‘AMA’ or Against Medical Advice form...” 1. Medical record review on 02/12/2025 for Patient #6 revealed a 75-year-old female admitted to the facility for ICHD treatments on 12/06/2024. The review of the Physician’s dialysis orders revealed the patient’s frequency for ICHD was three times per week for 240 minutes. The review of the treatment sheet dated 01/20/2025 revealed that the patient received dialysis for 171 minutes (69 minutes less than the prescribed 240 minutes). The review of the treatment sheet dated 01/31/2025 revealed that the patient received dialysis for 166 minutes (74 minutes less than the prescribed 240 minutes). The review revealed no documentation of the rationale for the patient not running the full prescribed treatment time on 01/20/2025 and 01/31/2025. The review revealed no completed AMA form for early termination of the treatment on 01/20/2025 and 01/31/2025. An interview with the CM on 01/13/2025 at 1315 revealed that no AMA forms were located for the patient on those days. The CM reported that any treatment terminated before the prescribed time was considered early termination, and all early termination should require completing the AMA form. The interview confirmed that the facility could not locate the forms and confirmed the findings. 2. Medical record review on 02/13/2025 for Patient #7 revealed a 71-year-old female admitted to the facility for ICHD treatments on 04/08/2020. The review of the Physician’s dialysis orders revealed the patient’s frequency for ICHD was three times per week for 210 minutes. The review of the treatment sheet dated 01/20/2025 revealed that the patient received dialysis for 171 minutes (39 minutes less than the prescribed 210 minutes). The review of the treatment sheet dated 01/31/2025 revealed that the patient received dialysis for 181 minutes (29 minutes less than the prescribed 210 minutes). The review revealed no documentation of the rationale for the patient not running the full prescribed treatment time on 01/20/2025 and 01/31/2025. The review revealed no completed AMA form for early termination of the treatment on 01/20/2025 and 01/31/2025. An interview with the CM on 01/13/2025 at 1315 revealed that no AMA forms were located for the patient on those days. The CM reported that any treatment terminated before the prescribed time was considered early termination, and all early termination should require completing the AMA form. The interview confirmed that the facility could not locate the forms and confirmed the findings. b. A review on 02/12/2025 of the facility policy titled “Patient Assessment and Monitoring” revised 05/01/2023 revealed, “...During Treatment ...3. Machine Parameters and Extracorporeal Circuit Check machine settings and measurements: Check prescribed blood flow is being achieved, or reason is documented in the medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered...” 1. Medical record review on 02/12/2025 for Patient #6 revealed a 75-year-old female admitted to the facility for ICHD treatments on 12/06/2024. A review of the Physician’s dialysis orders revealed Patient #6’s Blood Flow Rate (BFR) was set at 450 and Dialysate Flow Rate (DFR) was set to autoflow at 1.5 of the BFR. A review of the Treatment Flowsheet dated 01/29/2025 revealed Patient #6’s hemodialysis treatment was initiated at 0649 and ended at 1035. A review of the Flowsheet revealed Patient #6’s BFR average was 400 and DFR average was 600, with no documentation for the change in BFR and no documentation of the Registered Nurse notification. A review of the Treatment Flowsheet dated 01/31/2025 revealed Patient #6’s hemodialysis treatment was initiated at 0733 and ended at 1019. The review of the Flowsheet revealed Patient #6’s BFR average was 250 and DFR average was 500 with no documentation for the change in BFR and DFR and no documentation of the Registered Nurse notification. An interview with the CM on 02/13/2025 at 1315 revealed that PCTs should notify the nursing staff anytime they increased and/or decreased the patient’s BFR/DFR or were unable to achieve the ordered BFR/DFR. The interview revealed that the nursing staff should have assessed and documented after the PCTs the reason for the decreased BFR/DFR during the patient’s treatment and determined if the patient needed to be referred to the access center. The interview confirmed that patient #6 was not treated according to the prescribed BFR/DFR in two of the six treatments reviewed. 2. Medical record review on 02/13/2025 for Patient #1 revealed a 77-year-old male admitted to the facility for ICHD treatments on 11/08/2024. The review of the physician’s dialysis orders revealed that Patient #1’s Blood Flow Rate (BFR) was set at 450 with Dialysate Flow Rate (DFR) set to autoflow at 1.5 times the BFR. A review of the Treatment Flowsheet dated 01/24/2025 revealed Patient #1’s hemodialysis treatment was initiated at 1210 and ended at 1615. A review of the Flowsheet revealed Patient #1’s BFR average was 400 and DFR average was 600, with no documentation for the change in BFR and no documentation of the Registered Nurse notification. A review of the Treatment Flowsheet dated 01/27/2025 revealed Patient #1’s hemodialysis treatment was initiated at 1221 and ended at 1624. The review of the Flowsheet revealed Patient #1’s BFR average was 350 and DFR average was 600, with no documentation for the change in BFR and DFR and no documentation of the Registered Nurse notification. An interview with the CM on 02/13/2025 at 1315 revealed that PCTs should notify the nursing staff anytime they increased and/or decreased the patient’s BFR/DFR or were unable to achieve the ordered BFR/DFR. The interview revealed that the nursing staff should have assessed and documented after the PCTs the reason for the decreased BFR/DFR during the patient’s treatment and determined if the patient needed to be referred to the access center. The interview confirmed that patient #6 was not treated according to the prescribed BFR/DFR in two of the six treatments reviewed.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 38766 Based on facility policy review, personnel “Job Description” reviews, personnel file review, and staff interviews, the facility failed to ensure that direct patient care staff had current certification in CPR (Cardiopulmonary resuscitation) for four (4) of five (5) sampled personnel files (PCT #2). Findings included: A review on 02/13/2025 of the facility’s policy “Credential and Verification Requirements” effective 12/15/2020 revealed, “Introduction Certain positions within the Company require employees to have and maintain a valid credential in good standing in order to perform specific requirements of the job ... Applies to This policy applies to all newly hired and current employees ... In addition to credential requirements, this may include other certifications, including but not limited to Cardiopulmonary Resuscitation (CPR) or Basic Life Support (BLS). A review of the facility’s “Job Description” for a “Patient Care Technician II” revealed, “...Experience and Required Skills: ...*Continued employment is dependent on successful completion of the organization dialysis training program and successful completion of CPR certification...” A review of the facility’s “Job Description” for an “Outpatient RN” revealed, “...Education and Licensure ... Current or successful completion on CPR BLS certification...” 1. A review of PCT #1’s personnel file on 02/132025 revealed that PCT #1 began employment with the company on a date unknown. The review also showed that the PCT did not have a CPR certification on file, and it revealed that the PCT continued employment at the facility while not having a valid CPR certification file. An interview on 02/13/2025 at 1450 with the Clinical Manager (CM) revealed that PCT #1 was a visiting staff from another clinic and did not have a copy of the PCT’s CPR on file. 2. A review of PCT #3’s personnel file on 02/13/2025 revealed that PCT #3 began employment with the company on 08/14/2017. The review showed the PCT had a CPR certification on file that expired on “07/31/2023”. The review revealed the PCT continued employment at the facility while not maintaining a valid CPR certification from 07/31/2023 through 0the present (over 18 months). An interview on 02/13/2025 at 1450 with the Clinical Manager (CM) confirmed that the staff CPR had expired after 07/31/2025. The interview revealed that the CM was responsible for keeping up with the employees’ files, but the CM was on leave for a few months and had not reviewed the personnel files. 3. A review of PCT #4’s personnel file on 02/13/2025 revealed the PCT began employment with the company on 04/24/2027. The review showed the PCT had a CPR certification on file that expired on “07/31/2023”. The review revealed the PCT continued employment at the facility while not maintaining a valid CPR certification from 07/31/2023 through the present (over 18 months). An interview on 02/13/2025 at 1450 with the Clinical Manager (CM) confirmed that the staff CPR had expired after 07/31/2025. The interview revealed that the CM was responsible for keeping up with the employees’ files, but the CM was on leave for a few months and had not reviewed the personnel files. 4. A review of RN #5’s personnel file on 02/13/2025 revealed the RN began employment with the company on 02/10/2020. The review showed the RN had a CPR certification on file that expired on “04/30/2024”. The review revealed the RN continued employment at the facility while not maintaining a valid CPR certification from 04/30/2024 through the present (over 8 months). An interview on 02/13/2025 at 1450 with the Clinical Manager (CM) confirmed that the staff CPR had expired after 07/31/2025. The interview revealed that the CM was responsible for keeping up with the employees’ files, but the CM was on leave for a few months and had not reviewed the personnel files. NC00225375 NC00225504”