Fmc - Lagrange Dialysis Clinic

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 33921 Based on observation, staff interviews, a review of facility Policy and Procedures (P & P), and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Director of Operations to ensure that the expired Standard pH 7.00 Buffer Solution (used to calibrate pH meters by providing a known pH value of 7.00 before use to ensure the pH result was accurate), was replaced when notified by this surveyor and was handed the expired solution, and to ensure that one of one Patient Care Technician (PCT AA), who was assigned to calibrate two of two Myron L D-6 Digital Dialysate Meters (a meter specifically designed to measure Conductivity [measurement of the dialysate’s ability to conduct electricity], pH [acidity] and Temperature), performed and followed the proper procedure in calibrating the Myron L D-6 Digital Dialysate Meters, before daily use. Improper calibration of a Myron L D6 Meter in dialysis can lead to dangerously inaccurate measurements of dialysate (such as pH and Conductivity), resulting in improper electrolyte balance, ineffective toxin removal, and severe patient harm, including cardiac issues, low blood pressure, and even death, as the dialysis machine adjusts treatment based on bad data, compromising patient safety and treatment efficacy. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain), could result if dialysate composition is incorrect. This deficient practice had the potential to negatively affect the health and safety of all 19 patients (P), (P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20 and P#21), who were undergoing hemodialysis treatment at the time of this observation. The facility ICHD patient census was 75. Findings include: - During a tour of the Dialysate Preparation Room with the Biomedical Technician (BMT) on 12/30/25 at approximately 2:00 p.m., it was observed that one of one bottle of Standard pH 7.00 Buffer Solution that was on the cart with the other solutions (such as 4.00 and 10.00 pH buffer solutions, 14.00 mS Conductivity solution, and Myron L D-6 Digital Dialysate Meter...), had an expiration date of 12/18/25, and it was opened on 12/17/25. The BMT acknowledged this observation at the time and date of discovery. The Director of Operations also came to the Dialysate Preparation Room on 12/30/25 at approximately 2:05 p.m., and was also notified of the expiry date of the Standard pH 7.00 Buffer Solution, and this surveyor handed the bottle of the expired solution to the Director of Operations. - On 12/31/25 at approximately 9:15 a.m., this surveyor went back to the cart (in the Dialysate Preparation Room), with the solutions and Myron L D-6 Digital Dialysate meter for the daily calibration of dialysate, and found out that there was no Standard pH 7.00 Buffer Solution (the expired bottle had not been replaced), that would have been needed for the daily calibration of two of two Myron L D-6 Digital Dialysate Meters before use. - During an interview with PCT AA on 12/31/25 at approximately 9:20 a.m., PCT AA acknowledged that there was no available Standard pH 7.00 Buffer Solution to use for calibration this morning before the start of patient treatments, and PCT AA added that she skipped this calibration procedure (that required the use of Standard pH 7.00 Buffer Solution). A review of facility Procedure with reference #64380, version 2, titled, “Myron L D6 Meter Maintenance Procedures”, published 09/01/2022, stated: Daily Verification: Materials Required: Myron L D-6 Digital Dialysate Meter Myron L D-6 Daily Verification Form Calibration Solutions: * 14.00 mS Conductivity Solution * 3000 ppm 442 Standard Solution * 4.0, 7.0 and 10.0 pH buffer solution * pH sensor storage solution Procedure: Step: ... 4. At the beginning of the day, check conductivity, TDS (442), and pH solution expiration dates. Discard expired solutions or solutions that are found without a cap. Use unexpired solutions for meter verification... 7. Measure a sample of 7.00 pH buffer solution in accordance with manufacturer IFU (instructions for use). Compare results with acceptable range on form... 8. Measure a sample of 4.00 pH buffer solution in accordance with manufacturer IFU... 9. Measure a sample of 10.00 pH buffer solution in accordance with manufacturer IFU... NOTE: Leaving the pH calibration after the 2nd buffer calibration, results in an incomplete calibration of the pH function, and the same gain being entered in the place of the 3rd buffer. Make sure to calibrate all three buffer solutions before exiting pH calibration. According to ANSI/AAMI RD52: 2004, Section 5.6, “Dialysate Proportioning”, it is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of patients. - The BMT stated on 12/31/25 at 10:25 a.m., that failure to calibrate according to IFU (using all three pH buffer solutions - 7.00, 4.00 and 10.00), will affect the pH of the final dialysate. The Director of Operations and the Clinic Manager were notified of the above observations on 12/31/25 at 10:30 a.m.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 53051 Based on observation, staff and patient interviews, a review of facility records, and the facility’s Policy and Procedures (P&P), it was determined that the Clinic Manager /Facility Administrator (CM/FA), failed to ensure that all Staff (nurses, Patient Care Technicians [PCTs], Social Worker [SW], Registered Dietitian [RD], and CM/FA), adhered to facility P & P relative to addressing patients’ concerns, grievances and complaints to ensure all patients were provided with support and resolution, respect and dignity. This deficient practice had the potential to negatively affect the emotional health and safety of all 75 patients who were under the care of this facility. Findings include: During observation in the Patient Treatment Room on 12/30/25 between 9:30 a.m. and 10:45 a.m., it was observed that all staff were respectful to all patients during initiation and termination of dialysis treatments (shift change from first to second shift). P#1 was not present. During staff interviews on 12/30/25 between 9:45 a.m. and 3:10 p.m., the following was revealed: - At 9:45 a.m., the Registered Nurse/Charge Nurse (RN/CN) stated that patient (P#1) tended to yell during treatments, which made other patients feel anxious. RN/CN added that P#3 had voiced her concern about P#1’s yelling, stating that it caused her anxiety and she had contemplated stopping her treatment and going home. RN/CN also stated that this complaint had been forwarded to management, and she had suggested that P#1 be assigned a sitter, noting that he appeared calm when someone was nearby. She was told by management that they required more documentation of the complaints before they could take any action. RN/CN stated that she felt disheartened by this, as there had been serious complaints by other patients regarding P#1 over the past two months, and CM/FA had spoken to P#1, but it had not been effective. - At 10:30 a.m., Licensed Practical Nurse (LPN AA) reported that P#1 yelled and used inappropriate language. Next to P#1 was P#2, who was diagnosed with cancer and lupus (a chronic autoimmune disease where the body’s immune system mistakenly attacks healthy tissues and organs). P#2 was frail and had requested some quiet time, but it was difficult for her to get that peace. Whenever someone was with P#1, he would stop yelling, but as soon as they left, he would start yelling again. LPN AA stated that she had reported the situation to management but was told there was nothing they could do since P#1 also needed hemodialysis treatment. - At 12:15 p.m., the CM/FA stated that there were no filed grievances/complaints related to P#1. The CM/FA stated that she recalled a single complaint she had received, which pertained to a patient complaint on 12/16/25, brought to her attention by LPN AA. However, LPN AA did not specify which patient had voiced the complaint. CM/FA also stated that she approached P#1 in the Patient Treatment Room to discuss the issue and she observed that P#1 remained calm during the interaction. CM/FA also added that she escalated the matter to the Social Worker (SW) for further follow up. CM/FA also mentioned that there was no documentation in P#1’s records regarding his disruptive behavior during treatment, except for the incident mentioned on 12/16/ 25, which she followed up with a discussion with P#1. - At 1:01 p.m., the SW reported that there were no filed grievances related to P#1. She stated that staff members had been discussing about P#1’s yelling during his dialysis treatment however, she stated that this behavior had not been formally brought to her attention. SW stated that she recalled an incident while she was at the Patient Treatment Room, where P#1 called out for his deceased wife. During that time, the Registered Dietitian (RD) had to sit beside him during treatment because P#1 was yelling and complaining of back pain. SW also mentioned that she was unaware of the incident that took place on 12/16/25, as she was not present at the facility. - At 2:01 p.m., LPN BB reported that P#1 had been yelling during treatment. His outbursts caused concern and discomfort among other patients, some of whom mentioned that it made them feel scared and disturbed. LPN BB also stated that P#1 was not in any distress when staff attended to him; he was simply seeking attention. She stated that the situation was frustrating and that nurses had been documenting P#1’s behavior in P#1’s progress notes. However, not much had been done to address the concerns of the other patients. - At 3:10 p.m., PCT AA reported that P#2 complained about the noise from P#1. P#2 wanted a quiet environment to rest during her treatment because she was weak as a result of her other co-morbidities. PCT AA added that she tried to talk to P#1, but P#1 ignored her and kept yelling. This incident was not recorded. During patient interviews on 12/30/25 between 9:35 a.m. and 10:18 a.m., the following was revealed: - At 9:35 a.m., P#3 mentioned that she had been dialyzing for years and stated that she had never witnessed any patient yelling like P#1 during treatment. She indicated that he had used bad words towards the nurse, which made her feel anxious, and thought that if she could just stop treatment and go home. She had reported her concerns to the nurses, and they often talked to P#1, but it didn’t change anything. She noted that no one in management had come to her to address her concerns. - At 09:55 a.m., P#4 stated that she wore her headphones when she came for treatment and watched the television so P#1’s yelling didn’t disturb her that much. - At 10:18 a.m., a telephonic interview was conducted for P#2, but she sounded very weak and mentioned that she was in the hospital. A review of facility records such as: Patient Safety Events, Adverse Event Reports, and Patient Grievance Reports for the past 12 months showed no reports regarding P#1’s behavior nor any concerns raised by the other patients about him. A review of P#1’s Clinical Notes Report from 10/14/25 to 12/17/25, showed documentation where nurses addressed P#1’s behavior of yelling, calling staff names, and being disruptive. The CM/FA, who was aware of the situation (according to the nurses’ notes), came to the Patient Treatment Room to talk to P#1 on 12/16/25, and stated that she (CM/FA) had also referred P#1 to the SW. A review of facility P&P: Version 4, titled, “Patient Grievance”, with a revision date of 5/5/25, stated: A patient or designated representative may register a verbal or written complaint at any time, directly or anonymously, through the following channels, identified on the “Important Numbers” document: “Any facility staff member, Clinical Manager, or Director of Operations”. It is expected that all staff members will attempt to address and resolve patient complaints immediately, within the timeframe of the patient/representative encounter.”

“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: 53051 Based on staff interviews, a review of facility records, and a review of facility Policy and Procedures (P&P), it was determined that the Medical Director failed to ensure that one of one Registered Nurse/Charge Nurse (RN/CN), two of two Licensed Practical Nurses (LPN AA and LPN BB), and one of one Patient Care Technician (PCT BB) interviewed, were sufficiently trained and followed P & P relative to caring for one of one patient (P#5), with LVAD (Left Ventricular Assist Device - a mechanically powered circulatory support device that is surgically implanted to assist the left ventricle in pumping blood to the systemic circulation in a patient with advanced, end-stage heart failure), and failure to ensure that P#5’s Nephrologist had specific hemodialysis (HD) orders for fluid removal or Blood Pressure (BP) / Mean Arterial Pressure (MAP) parameters. These failures could lead to incorrect BP assessments and serious complications, such as reduced LVAD flow or cardiovascular compromise. Accurate BP monitoring and proper fluid management are crucial for safely caring for LVAD patients during hemodialysis. These failures had the potential to negatively affect the health and safety of P#5. The facility census was 75. Findings include: During staff interviews on 12/31/25 between 11:00 a.m. and 4:33 p.m., the following was revealed: - At 11:00 a.m., LPN AA reported that staff had received video training on caring for P#5 (with LVAD) that was provided by the hospital, however, she stated that the training lacked hands-on practice and was not sufficiently in-depth. This left many staff members feeling uncomfortable and lacking confidence in their ability to care for LVAD patients, specifically P#5. LPN AA emphasized the necessity for comprehensive training and clearer guidelines on managing such a patient in emergencies. LPN AA also mentioned that they were instructed to contact the LVAD Team and perform standard Cardio-pulmonary Resuscitation (CPR) in case of any changes in P#5’s condition. - At 11:25 a.m., PCT AA stated that she had received a video presentation as training for the care of P#5. She also stated that it did not include any hands-on demonstration. PCT AA added that she was not comfortable caring for P#5 because of his LVAD, and up to this date, she had never cared for P#5 because she was an opener, and P#5 was not assigned to her section, which had been a great relief to her. - At 11:50 a.m., RN/CN stated that the training she received for handling LVAD patients was not very detailed or thorough. The training was primarily verbal and lacked comprehensive hands-on experience before P#5 arrived at the facility. She mentioned feeling completely uncomfortable managing P#5 with his LVAD, as this was her first exposure to one, which added to her stress when P#5 was at the facility for his hemodialysis treatment. RN/CN also stated that because P#5 didn’t have a detectable pulse, it would complicate management in the event of a CPR situation. Additionally, she stated that they were instructed not to touch the LVAD device when an alarm went off but they were supposed to contact the LVAD Team instead. This level of responsibility made her anxious, especially since she did not feel confident in managing P#5 as a RN. She also mentioned that when she voiced her concerns with the management, she was reassured that the LVAD device would alert them in case of an emergency involving P#5. However, she felt this assurance was insufficient, as she remained skeptical about her ability to handle an emergency situation. - At 12:03 p.m., RN AA stated that she was a Float Nurse (nurse who worked between facilities to cover staffing shortages) and had been a nurse for eight years. She added that she had taken cared of patients with LVAD in the past and felt comfortable in taking care of patients with LVAD devices. She also stated that she had not received training at this facility regarding caring for patients with LVAD. - At 02:01 p.m., LPN BB stated that she had only viewed a training video for the LVAD device. She felt comfortable monitoring P#5’s BP using a Doppler (a type of ultrasound that uses sound waves to measure blood flow, showing the speed and direction of blood in vessels, helping diagnose clots, blockages and other circulatory issues...), but stated that the training had lacked practical demonstration and clear directives on how to handle P#5 during an emergency. Additionally, LPN BB pointed out that P#5’s order for HD was not specific regarding the amount of fluid to be removed. LPN BB described her experience in caring for P#5 as stressful, particularly because some of the PCTs had refused to be assigned to P#5, resulting in nurses always being assigned to P#5. LPN BB added that during pre-assessment, she only checked P#5’s vitals and weight, because they were told not to touch the LVAD device. That P#5 will be the one to tell them of any alarms. She also stated that their concerns had been communicated to management but were dismissed, with the instructions to contact the LVAD team if they faced any challenges. - At 3:10 p.m., PCT BB stated that she had several years of experience in dialysis and had been working at the current facility for a year. She mentioned that she had not received any training regarding the care of patients with LVAD and she did not know how to care for patients with LVAD nor the device itself. At one point, P#5 was assigned to her section, but she declined the assignment because she did not know how to provide the necessary care for P#5. - At 4:00 p.m., a telephonic interview was conducted with the Medical Director (MD), who expressed awareness of P#5 with the LVAD device being treated at the facility. He explained that the facility had a specific protocol for managing LVAD patients, which included guidelines for BP monitoring, ultrafiltration goals, and fluid replacement interventions. The MD voiced concerns about the staff’s discomfort and lack of adequate training in caring for LVAD patients, emphasizing that this situation posed risks to patient safety. He stated that he will discuss this issue with the nursing manager to ensure the staff would receive re-education/re-training and become more confident in their care for patients with LVAD. The MD also clarified that although P#5 was not under his direct care, he stated that the HD orders for P#5 should incorporate the relevant protocol and procedural specifications. He also mentioned that he will communicate with P#5’s Nephrologist to ensure the HD orders were clearly outlined for the nursing staff to follow. - At 4:33 p.m., during a telephonic interview with P#5’s Nephrologist, he acknowledged that his HD orders lacked clear guidelines regarding the parameters for BP, fluid removal, and fluid replacement during emergencies. He explained that one of the main reasons for this was that P#5 had been urinating well and had good lab results, which led him to hold P#5’s HD treatment for a week. However, he recognized that the nurses had no clear directives on how much fluid to remove since it was not specified in the orders, something he intended to address. He stated that his office was in close proximity to the facility and assured that nurses were encouraged to reach out to him or the Nurse Practitioner (NP) for any clarifications needed. - A review of the facility’s Personnel File, showed eight nursing staff (RNs and LPNs) and nine PCTs. According to the Wellstar Health System (LVAD Team’s) records dated 12/5/25, it showed that three RNs including CM/FA, two LPNs and three PCTs attended the virtual presentation of the LVAD training presented by the LVAD Coordinator, and on 12/6/25, two RNs were verbally educated by the facility’s CM/FA. - According to P#5’s Treatment Sheets for the Facility (hemodialysis treatment records), P#5 had six hemodialysis treatments at the facility since 12/9/25 (his first day of treatment). On 12/17/25, P#1’s HD treatment was placed on hold for one week because his lab results were good, and he had good urine output. On 12/28/25, P#5’s HD treatment was resumed, and he was supposed to get his labs done on 12/30/25, but P#5 didn’t come for his HD treatment. In all of P#5’s HD treatment records, the HD order had no specifications regarding BP measurement parameters, no target fluid removal, and no specific fluid replacement intervention, which needed to be detailed according to facility procedures and protocols. According to the facility’s P & P, with Reference number: 23514, Version 3, titled, “Clinical Services: Setting - IPS, for the Left Ventricular Assist Device”, published 02/03/25, it stated: The facility RN must visualize the time left on the battery in use and the charged backup battery to ensure there is enough total battery time for the patient’s treatment. The patient may be connected to a Power Base Unit (PBU) during dialysis if ordered by the treating physician. Blood pressure is most accurately obtained by using a manual BP cuff and a Doppler probe. And has the steps to follow to measure the MAP, which also stated the normal MAP is 70-90 millimeters of mercury (mmHg). The facility RN will review the treatment orders before treatment, which must include: - BP monitoring method - Ultrafiltration goals - Fluid replacement - Cardiopulmonary resuscitation. Should verify whether chest compressions are permitted before the start of treatment.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 33921 Based on a review of facility records, staff interview, a review of the facility’s Policies and Procedures (P&P), and a review of AAMI (Association for the Advancement of Medical Instrumentation), it was determined that the facility failed to ensure that total chlorine (the sum of free chlorine and chloramine) testing (used to detect the presence of chlorine and chloramines in the water used for dialysis), was performed and documented every four hours as required. This was evidenced by test results being recorded between six hours and 23 minutes and between five hours and 7 minutes, past the required testing intervals. Failure to perform timely testing for chlorine and chloramine can result in harmful exposure to patients, potentially leading to serious adverse outcomes such as hemolysis (destruction of red blood cells), cardiac arrhythmias, and hypotension. This failure had the potential to cause harm to the health and safety of all 75 in-center hemodialysis patients who were under the care of this facility. Cross Reference: V 196 - Failure of the facility to ensure that total chlorine testing was performed and documented every four hours as required by facility P & P and AAMI.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 33921 Based on record review and staff interview, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to cause harm to the health and safety of all 75 in-center hemodialysis patients who were receiving dialysis services at this facility. Findings include: Cross Reference: V 196 - Failure of the facility to ensure that total chlorine testing (used to detect the presence of chlorine and chloramine in the water used for dialysis), was performed and documented every four hours as required by facility P & P and AAMI.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 33921 Based on a review of facility records, staff interview, a review of the facility’s Policies and Procedures (P&P), and a review of AAMI (Association for the Advancement of Medical Instrumentation), it was determined that the facility failed to ensure that total chlorine (the sum of free chlorine and chloramine) testing (used to detect the presence of chlorine and chloramines in the water used for dialysis), was performed and documented every four hours as required. This was evidenced by test results being recorded between six hours and 23 minutes and between five hours and 7 minutes, past the required testing intervals. Failure to perform timely testing for chlorine and chloramine can result in harmful exposure to patients, potentially leading to serious adverse outcomes such as hemolysis (destruction of red blood cells), cardiac arrhythmias, and hypotension. This failure had the potential to cause harm to the health and safety of all 75 in-center hemodialysis patients who were under the care of this facility. Findings include: A review of the facility’s “FKC Log Readings Report for Total Chlorine (TCL)”, from September 2025 to November 19, 2025, revealed the following: - On 11/6/25, there was an interval of six hours and 23 minutes between Total Chlorine Tests of the Reverse Osmosis (R.O.) product water or permeate, from 9:43 a.m. (previous total chlorine test) to the next total chlorine test at 16:06 (4:06 p.m.). - On 11/18/25, there was an interval of five hours and 7 minutes between Total Chlorine Tests, from 9:53 a.m. (previous test), to the next total chlorine test at 15:00 (3:00 p.m.). A review of facility Policy with Reference Number: 46310, version 12, titled, “ Carbon Filtration Monitoring for Incenter Central Water Systems Policy”, published on 05/05/2025, stated: Test Rationale: Total chlorine testing will be the only testing methodology used to ensure the granular activated carbon filters/bank of filters are reducing total chlorine levels below the Fresenius Kidney Care (FKC) limit of less than 0.1 ppm. (parts per million) Policy: * Total Chlorine test will be performed prior to initial treatment and every four hours. * All tests must be completed within 4 hours. * If unable to perform total chlorine testing within 4 hours of the previous test, treatments must be discontinued. There was no documentary evidence that the patients’ treatments were discontinued or paused on the above-mentioned dates. - The Clinic Manager verified the above findings on 11/24/25 at 3:14 p.m., stating that she reviewed the TCL (Total Chlorine) logs and noted that on 11/6/25, the chlorine check was completed at 9:47 a.m., due again at 1:47 p.m., but was not completed until 4:07 p.m., making it two hours and 20 minutes late. - The Clinic Manager further stated that on 11/18/25, the chlorine check was completed at 9:56 a.m., and due again at 1:56 p.m., but was not completed until 3:00 p.m., making it one hour and four minutes late. - This surveyor stated that it’s the timeframe (interval) between the last test and the next test that needed to be considered, (not from when the test was due), and the maximum timeframe or interval between tests (total chlorine tests) is four hours. If delayed even for five minutes after the four-hour interval, it will already pose a risk. To reiterate: - The TCL log on 11/6/25 showed previous test at 9:43 a.m., not 9:47 a.m., and the next test was at 4:06 p.m., not 4:07 p.m., as stated by the Clinic Manager. - And on 11/18/25, the TCL log showed previous test at 9:53 a.m., not 9:56 a.m., as stated by the Clinic Manager. - A review of AAMI, in collaboration with ISO (International Organization for Standardization), requires rigorous and timely monitoring of dialysis water, specifically for contaminants like chlorine and chloramine, to ensure patient safety. According to AAMI standards (e.g., RD 52, TIR 58), water used in dialysis must undergo total chlorine testing before each treatment shift and approximately every four hours during treatments. Why this matters: Timely testing is essential because chlorine or chloramine in the dialysate water can cause immediate and life-threatening harm to patients. Even small delays in testing increase the risk that contaminated water might be used in treatments, potentially resulting in: Hemolysis - Destruction of red blood cells due to chlorine exposure. Cardiac arrhythmias - Abnormal heart rhythms triggered by metabolic disturbances. Hypotension - Sudden drops in blood pressure, which can rapidly destabilize patients. Facilities that fail to monitor water on the required schedule are in direct violation of AAMI’s protocols and are placing patients at serious risk.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 03383 Based on a review of records, observation, and interviews, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 85 dialysis patients who were under the care of this facility. Findings include: Cross-Reference: V757 - Failure of the Governing Body to ensure the facility had adequate number of qualified staff to provide safe patient care, and to be in compliance with minimum state required staff-to-patient ratios as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift. Furthermore, despite inadequate staffing issues, this facility continued to admit new patients and transient patients.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 03383 Based on a review of records, observation, and interviews, it was determined that the Governing Body failed to ensure that the facility had adequate number of qualified staff to meet the needs of all patients, provide safe patient care, and to be in compliance with minimum state required staff-to-patient ratios as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift. Furthermore, despite inadequate staffing issues, this facility continued to admit new patients and transient patients. This deficient practice had caused delayed and missed dialysis treatments and had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, access sites, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, missed complications including but not limited to intradialytic hypotension (sudden drops in blood pressure [BP] which can occur when fluid is removed too rapidly), hypertension (elevated BP), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility census was 85. Findings include: A review of the “Patient Grievance Reports” dated 10/7/24 to 4/1/25 showed the following: 10/7/24: - Patient (P) #9: There is not enough staff or consistent staff and often pts (patients) has to wait in the lobby. Pt also states that when the clinic is running behind most patients get mad and leave. Pt also states that when the clinic is understaffed patient’s time gets cut and the staff takes their time getting patients on the machine that it should only take about 15 minutes, but it takes 1 hour... [sic]. 12/9/24: - P#5: Pt. is not happy about not being able to treat on Saturday. Pt states that she was turned down for treatment due to being understaffed. Pt is in clinic today struggling to breathe. - P#6: Pt states that the last 2 Saturdays he has not been able to receive his treatment due to the clinic being short staffed and refusing to treat patients. Pt states that they are playing with my life. Pt is not happy and would like something to be done about this ASAP (as soon as possible). - P#7: Pt is not happy with not receiving treatment on Saturday due to the clinic being understaffed. Pt would like to know when facility will have a full-time staff. - P#8: Pt states that this clinic is a train wreck. Pt states that this facility has no discipline. Pt states that he was unable to treat on Saturday and waited in the lobby for a long time, and no one came out to check on him. Pt states that he had to call 911. Pt states 911 was about to kick the door down. Pt states that he feared for his life and was having a hard time breathing and is still struggling to breathe today. Pt states this has happened multiple times. Pt would like to see some changes made. The resolution for complaints dated 12/9/24 showed: Job requisitions are open. Interviews in progress, permanent float staff in place. During observation in the Patient Treatment Room on 4/1/25 between 10:15 a.m. and 11:00 a.m., the following was revealed: There were two Registered Nurses (RN AA and RN BB) and four Patient Care Technicians (PCT EE, PCT FF, PCT GG, and PCT HH); PCT DD called out. RN AA was scheduled to arrive at 6:20 a.m. and RN BB was scheduled to arrive at 7:30 a.m. RN AA indicated that there were 29 patients scheduled for treatment. During staff and patient interviews on 4/1/25 between 10:20 a.m. and 11:46 a.m., the following was revealed: - At 10:20 a.m., RN AA stated we are missing a tech (PCT) today; we moved patients around and cancelled some patients today; two patients were rescheduled and one patient refused to return. On TTS (Tuesday, Thursday, Saturday) the last four at least, we have been short or some kind of issues popped up. We did not have an opener on 3/20/25 so we got a late start. We did not have a charge nurse; I work part-time. We have a full-time LPN (Licensed Practical Nurse) that works for the company, everybody else is in the float pool or from a travel agency; some are from Fresenius, and some are from an outside agency. - At 10:27 a.m., P#1 stated, we have a nurse who comes in when she wants to come in and we (patients) had to stand outside in bad weather; we have to stand outside if there is one nurse (LPN). We had to stand outside this morning. This has been going on since November of last year (2024). Techs have left because of staffing; we have lost a lot of good techs. Takes too long to respond to machine alarms, between 5-10 minutes. Staff here don’t work as a team, only respond to their patients. We did not get on at scheduled time because there wasn’t enough staff this morning. Medical transport cannot stick around until staff open the door, so we are stuck outside. We have pointed out to the Clinic Manager (CM) that the nurse (RN BB) does not arrive on time. They changed the time patients arrive. I used to come in at 5:00 a.m., now I come in at 7:00 a.m. and the staff still cannot arrive on time. - At 10:38 a.m., RN BB stated, she has been at this facility since 12/23/24 from an outside agency. The first nurse usually arrives about 6:20 a.m., it used to be 4:15 a.m. Stated that they don’t have the staffing ratios per Georgia regulations. If short, the RN must step in. RN BB indicated that they have been short almost every day, that she can count on one hand when the facility was fully staffed. The facility had to get techs from other clinics. MWF (Monday, Wednesday, Friday) treatments start at 4:00 a.m. and closes around 7:30 p.m. The nurse usually works 12 hours on MWF and 10 hours on TTS. Staff leave when ratios go down, techs can leave when we are down to eight patients and one of the nurses can leave when the ratio is 10:1 (10 patients to one nurse). - At 10:46 a.m., P#2 stated, I have complained multiple times about the staffing. I passed out in August of last year and went to the hospital, but no one notified my wife about it. Stated, the staff could call and tell the patients when there will be a delay. Sometimes, patients had to wait for two hours before they let us know there is a problem with staffing or other issues. Stated “this happens quite a bit on Saturdays. They are playing with my life. They didn’t have enough staff here last Thursday while they had problem with the water, and I waited for two hours in the parking lot. It’s really rough here.” - At 11:15 a.m., the CM stated, one PCT called out today. They rescheduled four patients. One patient declined to come in tomorrow because of a doctor’s appointment. P#4 refused to come in tomorrow, he usually refuses to return the next day. They rescheduled patients who can drive to the clinic because it’s harder to reschedule transport patients. Stated, we don’t have enough permanent staff, and we are down a charge nurse. We are currently trying to hire a charge nurse and permanent staff. A nurse is scheduled to start on 4/11/25. The travel nurse has been late a couple of times and the opener alternates between the staff. Two techs left the first part of December 2024. The problem is getting people to work from 4:45 a.m. to 7:30 p.m. Stated, we are honest up front to let interviewees know about working long shift on MWF because we don’t have enough full-time staff to split the shift. - At 11:25 a.m., RN AA stated the following additional comments: A lot of staff complain about MWF; it runs until 7:30 p.m. We are losing techs, they work 4:45 a.m. to 7:30 p.m., it is excessive. P#3 still works, and we are accommodating her until 7:30 p.m. An RN and a tech must stay until the patient’s treatment is completed. The rest of the patient treatments are finished by 5:30 p.m. - At 11:46 a.m., the Director of Operations (DO) stated that distance is an issue because the location of this facility is not the best, kind of in the middle of the surrounding cities. The long shift on MWF is also an issue. Stated they have been trying to recruit PCTs for about two years and recruiting for RN has been a challenge. Stated that they were up front and honest during interviews and the long day on MWF has been an issue and will split the shift when people fill the positions. A review of “Staff/Patient Assignment” sheets dated February 24, 2025, and March 17, 2025 through April 1, 2025 revealed the following: On Monday, 2/24/25: There were 20 patients who were scheduled on the first shift, 20 patients on second shift, and five patients on third shift. There were four PCTs, one LPN and one RN who were scheduled to work. During an interview on 4/1/25 at 12:10 p.m., the CM stated that they got a late start because the opener did not show up and patient treatments were started late. The CM stated four patients did not receive their treatment on this date. The first patient treatment started at 6:50 a.m. Start times for patient treatments were scheduled at 4:45 a.m., 5:05 a.m., 6:10 a.m., and 6:30 a.m. On Monday, 3/17/25: There were 20 patients who were scheduled on the first shift, 20 patients on second shift, and five patients on third shift. There were three PCTs, one LPN, and one RN. One LPN was hand-written for Pod 4 and Pod 5 and then crossed out. Two PCTs were hand-written for Pod 4 and Pod 5 (each Pod had four stations). On 4/1/25 at 12:15 p.m., the CM stated that the facility worked short-staffed until 7:00 a.m. On Tuesday, 3/18/25: There were 20 patients who were scheduled on the first shift and 16 patients on second shift. There were four PCTs who were assigned to Pod 1, Pod 2, Pod 3, and Pod 4 but did not show anyone who was assigned to Pod 5. An LPN was hand-written on the schedule after crossing out one RN and another RN remained. A PCT was hand-written on the schedule for Pod 5. One LPN was hand-written for Pod 4 and Pod 5 and then crossed out. Two PCTs were hand-written for Pod 4 and Pod 5. The CM stated that the facility worked short-staffed until 7:00 a.m. The PCT who was scheduled for Pod 2 was crossed out. The CM stated that one PCT called out and three patients were moved to have treatment the next day. On Friday, 3/21/25: There were 20 patients who were scheduled on the first shift, 20 patients on second shift, and five patients on third shift. During an interview on 4/1/25 at 12:40 p.m., the Director of Operations (DO) stated, there was one PCT who called out and the LPN worked until 10:20 a.m. There were three PCTs who were assigned to Pod 2, Pod 3, Pod 4, and another PCT for Pod 5. The DO stated Pod 1 was closed and patients were moved to empty seats. One patient was moved to third shift. On Saturday, 3/22/25: On 4/1/25 at 12:24 p.m., the DO stated that a PCT who was not on the schedule arrived to open the water room and stayed until 9:00 a.m., Pod 5 was closed, patients were moved around, and three patients were rescheduled for treatment on Monday. On Monday, 3/24/25: There were 20 patients who were scheduled on the first shift, 20 patients on second shift, and five patients on third shift. The schedule showed four patients had central venous catheter (CVC - a flexible, hollow tube inserted into a large vein in the neck, chest, or groin to provide access for hemodialysis) on the first shift, seven CVC patients on second shift, and one on third shift. NOTE: In Georgia, only qualified licensed nurses are allowed to perform catheter site dressing changes, initiation, and termination of dialysis via CVC. On 4/1/25 at 12:31 p.m., the DO stated that patient treatments got a late start because there was no RN in the building; RN BB had classes (school) and the second RN had a family emergency. Patient treatments were shortened on this day. Two nurses (one RN and one LPN) were moved from a sister facility to cover. Treatments began at 6:48 a.m. On Wednesday, 3/26/25: There were 20 patients who were scheduled on the first shift, 20 patients on second shift, and nine patients on third shift. On 4/1/25 at 12:40 p.m., the DO stated that one RN called out and Pod 5 was closed. Patients were moved to third shift. On Friday, 3/28/25: There were 20 patients who were scheduled on the first shift, 20 patients on second shift, and nine patients on third shift. There were three PCTs, one LPN and one RN. At approximately 12:45 p.m. on 4/1/25, the DO stated that one PCT called out and the CM was out sick. The facility was short-staffed until 10:40 a.m. Patients were moved around. On Tuesday 4/1/25: On 4/1/25 at 1:07 p.m., the CM stated that the PCT who was assigned to Pod 2 called out. Two of the patients who were assigned to Station (S) 5 and S6 were moved to a different Pod on the first shift, one patient (at S7) was rescheduled for the next day, and one patient (at S8) left/refused treatment. There were two Registered Nurses (RN AA and RN BB) and four Patient Care Technicians (PCT EE, PCT FF, PCT GG, and PCT HH; PCT DD called out. RN AA was scheduled to arrive at 6:20 a.m. and RN BB was scheduled to arrive at 7:30 a.m. The schedule showed four Pod 2 patients on the first shift and three patients on second shift were crossed out on the schedule. There were five patients with CVC access on the first shift and nine CVC patients on second shift. A review of Treatment Sheets dated 4/1/25 showed the following: - P#10 left due to short staffing and unable to start Tx (treatment) on time, pt stated she would come back Thursday. CM, DO, and MD aware. Tx start time was 7:00 a.m. - At 6:16 a.m., P#11 got started late bc (because) [sic] of staffing issues. Tx start time was 5:05 a.m. - At 6:34 a.m., P#12 got started late bc [sic] of staffing issues. Tx start time was 5:25 a.m. - At 7:02 a.m., P#13 got started late bc [sic] of staffing issues. Tx start time was 6:05 a.m. - P#5 experienced elevated blood pressures that ranged from 188-209 systolic (top number) and 103-134 diastolic (bottom number) from 8:46 a.m. to 11:34 a.m. There was a lack of documented interventions that were done to address P#5’s extremely elevated blood pressure readings during dialysis treatment. - P#14’s BP ranged from 186-214 systolic and 103-121 diastolic from 7:47 a.m. to 10:04 a.m. P#14 refused clonidine and required closer monitoring. The CM and the DO confirmed the above findings on 4/1/25 at 2:30 p.m. A review of the Admissions/Discharges Report dated 10/1/24 to 4/15/25 showed that despite inadequate staffing, this facility continued to admit patients as evidenced by the following: There were 22 patients who were admitted from October 1, 2025, through April 15, 2025. - Three new patients (P#10, P#12, and P#17) and four transient patients (P#16, P#26, P#27, and P#28) were admitted in October 2024; - Four new patients (P#13, P#14, P#15, and P#18) and two transient patients (P#29 and P#30) were admitted in November 2024; - Two new patients (P#19 and P#20) were admitted in December 2024; - Three new patients (P#21, P#22, and P#23) were admitted in February 2025; - One transient patient (P#31) was admitted in March 2025; and - Three new patients (P#13, P#24, and P#25) were admitted to this facility in April 2025. During an interview on 4/15/25 at 1:30 p.m., the CM confirmed the above findings and stated that she did not make the decision to admit patients. Stated that the Regional Vice President (RVP) made the decision to admit those patients. On 4/15/25 at 1:58 p.m., the DO confirmed that the RVP made the decision about admissions to this facility. The DO also stated that there was a freeze on admissions that lasted for about a month. However, the DO could not remember the dates of the freeze. The DO stated that patients had not been directed to their back-up dialysis facilities for the past six months to a year. The CM stated that patients would not agree to going to the back-up facilities because the facilities are located 45 minutes to an hour away from the patients’ home. Stated that this option has not been offered. During an interview on 4/15/25 at 3:15 p.m., when asked if patients were triaged and documented before rescheduling the patients to return to the clinic on another day, the CM stated patients were triaged but was not documented.”

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 03383 Based on a review of records and staff interview, it was determined that the facility failed to ensure that the facility’s Emergency Preparedness Plan (EPP) included primary and alternate means for communicating with facility staff, federal, state, tribal, regional, and local emergency management agencies. The facility census was 84 in-center hemodialysis patients and seven home peritoneal dialysis patients. Findings were: A review of the facility’s EPP with the Clinic Manager on 3/16/24 at 1:50 p.m. revealed a lack of primary and alternate means for communicating with facility staff, federal, state, tribal, regional, and local emergency management agencies. The Director of Operations stated that the facility did not have an analog phone that would be used in the facility’s Emergency Preparedness Plan.”

“Methods for Sharing Information CFR(s): §403.748(c)(4)-(6), §416.54(c)(4)-(6), §418.113(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §441.184(c)(4)-(6), §460.84(c)(4)-(6), §482.15(c)(4)-(6), §483.73(c)(4)-(6), §483.475(c)(4)-(6), §484.102(c)(4)-(5), §485.68(c)(4), §485.542(c)(4)-(6), §485.625(c)(4)-(6), §485.727(c)(4), §485.920(c)(4)-(6), §491.12(c)(4), §494.62(c)(4)-(6). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (4) A method for sharing information and medical documentation for patients under the [facility’s] care, as necessary, with other health providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). [This provision is not required for HHAs under §484.102(c), CORFs under §485.68(c)] (6) [(4) or (5)]A means of providing information about the general condition and location of patients under the [facility’s] care as permitted under 45 CFR 164.510(b)(4). *[For RNHCIs at §403.748(c):] (4) A method for sharing information and care documentation for patients under the RNHCI’s care, as necessary, with care providers to maintain the continuity of care, based on the written election statement made by the patient or his or her legal representative. *[For RHCs/FQHCs at §491.12(c):] (4) A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). This Standard is not met as evidenced by: 03383 Based on document review and staff interview, it was determined that the facility failed to ensure that the facility’s Emergency Preparedness Plan (EPP) maintained a communication plan that included a method for sharing information and medical documentation for patients under the care of this facility, and as necessary, with other health providers to maintain the continuity of care. The facility census was 84 in-center hemodialysis patients and seven home peritoneal dialysis patients. Findings were: A review of the facility’s EPP with the Clinic Manager and the Director of Operations (DO) on 3/16/24 at 2:30 p.m. revealed a lack of documentation to confirm that the EPP included a method for sharing information and medical documentation for patients under the care of this facility, as necessary, with other health providers to maintain the continuity of care. The DO stated that the EPP did not specifically address the method of information sharing.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 03383 Based on observation, a review of Centers for Disease Control (CDC) recommendations and facility policy, and staff interview, it was determined that the Infection Control Committee (ICC) failed to ensure that four of four patients (P#19, P#21, P#23, and P#27) observed who held pressure to their access sites for hemostasis (stopping of the flow of blood) after dialysis, performed hand hygiene (wash hands with soap and water or use an alcohol based hand sanitizer) after glove removal and prior to leaving the treatment area. It was also determined that the ICC failed to ensure that one of one physician (Dr. TT) observed, performed hand hygiene after touching one patient and/or their machine keyboard/computer screen and before arriving to care for another patient or touch another patient’s machine keyboard/computer screen at another Station. This deficient practice had the potential for cross contamination and increased risk of infection and could affect 84 ICHD patients who were dialyzing at this facility. Findings were: During observation in the Patient Treatment Room on 3/12/24 and 3/13/24 between 8:15 a.m. and 9:00 a.m., the following was observed: - On 3/12/24, P#19 who was seated at Station (S) 11 held pressure to dialysis access site and left the facility without performing hand hygiene. - On 3/13/24, P#21, P#22, and P#27 who were seated at S2, S13, and S9 respectively, held pressure to dialysis access site. Pt#21, P#23, and P#27 left the facility without performing hand hygiene and were not reminded by the staff to wash their hands nor were offered to use hand sanitizer after glove removal. - On 3/13/24 beginning at 8:19 a.m., Dr. TT moved from patient to patient, and from one station to another. Dr. TT touched patients, the machine keyboards and screens with ungloved hands. Dr. TT did not perform hand hygiene after touching each patient and their machine keyboard/computer screen and before moving to another station and/or touching another machine keyboard and/or patient. - There were 20 patients who were receiving dialysis treatment during this observation. Dr. TT did not touch the patients who were asleep at the time, but touched their machine keyboard and computer screen. According to CDC, handwashing is the most important measure to prevent contaminant transmission... and even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal. A review of Policy titled, “Hand Hygiene” dated 11/06/23 showed the following: Hands Will Be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water. Immediately after removing gloves. During an interview with the Clinic Manager on 3/13/24 at 3:00 p.m., the CM did not offer any feedback pertaining to the above findings.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 03383 Based on observation and staff interview, it was determined that the Infection Control Committee failed to ensure that one of one physician (Dr. TT) observed, cleaned and disinfected stethoscope between patient uses. This failure could lead to the transmission of dangerous pathogens through cross contamination; and had the potential to negatively affect the health and safety of 20 of 20 in-center hemodialysis (ICHD) patients (Patients seated at Stations 1 - 20, who were undergoing hemodialysis treatment at the time of this observation. The facility had 84 in-center hemodialysis patients. During observation in the Patient Treatment Room on 3/13/24 beginning at 8:20 a.m., the following was revealed: - Dr. TT moved from patient to patient and listened to their lung sounds. - Dr. TT did not clean or disinfect stethoscope between patient uses. - Dr. TT did not wash hands with soap and water and did not clean the stethoscope until afterward, before leaving the treatment area. During an interview with the Clinic Manager (CM) on 3/13/24 at 3:00 p.m., the CM did not offer any comments related to the above findings.”

“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: 03383 Based on observation and staff interviews, it was determined that the facility failed to have a system in place to ensure that all equipment are maintained in safe and functional working condition. This environmental concerns were observed in four of 20 dialysis chairs, several dialysis machines and five of 20 television (TV) sets. This deficient practice could negatively affect the health and safety of 84 in-center hemodialysis patients who were dialyzing at this facility. Findings were: During observation in the patient treatment area on 3/13/24 between 4:15 a.m. and 4:20 a.m., the following was revealed: - The dialysis chairs at S7, S13, S15, and S17 had multiple torn leather upholstery on the seat of chair approximately one to three inches long. This could hinder effective cleaning/disinfection. The Charge Nurse was notified on 3/13/24 at 4:25 a.m. and confirmed the above findings. During an interview on 3/12/24 at 9:02 a.m., Patient (P) #2 stated “My machine went down after an hour of dialysis yesterday (Monday, 3/11/24). They brought out backup machines and those machines didn’t work either; nobody worked on them. I had to come in today because machines didn’t work yesterday. I used to miss treatments but not anymore. It’s a matter of life or death for me. These machines break down all of the time; they need new machines.” During an interview on 3/12/24 at 3:45 p.m., P#3 stated “I have been here for about two years and the TVs have not been working for at least a year and a half. They also have a lot of problems with dialysis machines. They don’t do nothing when we complain about things around here. I filed a formal grievance, I called someone last year and nothing happened.” During an interview with Staff AA on 3/12/24 at 2:13 p.m., it was revealed that some of the TVs were not working at all and they were supposed to get new TVs. Stated “we do have lots of problems with dialysis machines. The Biomed Technician (BMT) is not here full-time”. Staff AA also stated “I believe machines were not fixed when BMT indicated that the machines were fixed”. During an interview with the Biomed Technician (BMT) on 3/12/24 at 12:36 p.m., it was revealed that there were 23 Fresenius 2008 Gold Star machines; two of the machines were for back up. When machines on the floor go down, backup machines are used. The BMT stated “On Monday (3/11/24), I was here at 7:00 a.m., I received a call for repair at 6:00 a.m. One of the machines had a blood leak and the other machine was leaking. There was a new PCT (PCT LL) that had issues with the machine, but we couldn’t find a leak. I believe it was user error. The alarms were all okay. We have had a problem retraining a preceptor to train the PCTs on troubleshooting equipment for the last two years. The preceptor is responsible for training new staff on troubleshooting equipment. BMT also stated “We are waiting for approval for new TVs. We replaced the jacks; a company came in and replaced the wall jacks; the TVs were supposed to be replaced the first of the year; but now have to obtain another estimate to make sure the previous estimate for replacing TVs is still accurate. There are two BMTs from neighboring clinics that cover for me when I’m out.” During an interview with BMT from another clinic on 3/12/24 at 2:29 p.m. it was revealed that machines are pulled from the floor and backup machines were used. If the machines passed all tests, conductivity alarms and self-test, the machine is put through a rinse. Stated “We have had problems with Blue Star program (software) such as issues with memory, and it has been like this for a while. During an interview with Staff AA on 3/13/24 at 7:34 a.m., it was revealed that they had been experiencing problems with the TVs for over a year. The BMT was supposed to change them out but they would get a few and only a few would get fixed at a time. Stated “When we had problems with a dialysis machine, the machine would have a tag on it that indicated it had been repaired. However, when we tried to use it, the same problem happened and the machine remained unusable. This has been going on for over five years.” Staff AA added “I don’t think he is fixing the problem.” On 3/13/24 at approximately 8:00 a.m., PCT DD stated “The BMT keeps blaming us when machines are not running right; the machine in the Isolation Room has not worked in over a month, it has a yellow tag on it. We don’t have enough machines and the machines we have, don’t work. The machine alarms keep going off but I don’t feel comfortable going to management. I only feel comfortable with the floor staff.” During an interview on 3/13/24 at 9:15 a.m., the Area Technical Operations Manager (ATOM) indicated that the educator is responsible for training floor staff to troubleshoot machines, but Biomed is ultimately responsible for troubleshooting and repairing the machines. ATOM also confirmed issues with Fresenius Blue Star program that caused the machines to leak water, caused problem with setting DFR (Dialysate Flow Rate) and BFR (Blood Flow Rate) to the prescribed rate, and issues with alarms. A review of the Work Order (WO) Log dated October 2023 to February 2024 with the BMT on 3/13/24 at 9:15 a.m., revealed equipment was not always completed in timely manner. WO Logs revealed the following: 10/5/23: “Flow inlet error.” Per BMT: “Replaced keyboard” Completed on 10/09/23. 10/26/23: Chair remote has a flashing light, power issue when attempting to raise legs up or lay chair back. Per BMT: “work order already in TMS. No resolution given. Completed on 11/17/23. 11/11/23: “While in heat temp over 95, leaking everywhere. Per BMT: “Found losse [sic] wire on heater rod tighten wire no other problem”. Closed on 11/16/23. 12/2/23: “TMP on venous side reads high on every pt. Transducer keeps getting wet with blood. No back up machines available. Biomed notified.” Repair was completed on 12/4/23. 12/8/23: This was supposed to be a good back-up machine. It ran one patient and I had to pull it for cond. [conductivity] being stuck at 16.9, stuck in dialysate preparing, and stuck in dialyzer connected. BMT stated “Rinsed machine no problem found with the new software when machine flow drop to 100 sometimes a conductivity and temp will go out of limits but if you wait 5 minutes, it will come back within limits. Fresenius tech support also told us this.” WO was completed the same day. 12/15/23: “Machine will not prime, is kinking line will [sic] blood in pump”. BMT indicated he could not duplicate the problem. Problem was not completed until 12/21/23. 12/15/23: “Internet does not work on machine. It is the machine jack because the other machine that was there worked for the internet”. BMT replaced internet port in back of machine. BMT indicated he had to order metal jack; it was snatched out of the wall. Repair was done on 12/21/23. 12/31/23: TMP (Transmembrane Pressure), Conductivity, Temperature high, Leaking water from the back. Per BMT: With the new software, it drop the flow to 100. When this happens, staff should take the flow back to 500 and problem will go away in 5 minutes. 1/10/24: “Flow inlet error Cond. 10.0”. Per BMT: “Replaced bruses [sic]. Closed on 1/17/24. The BMT could not explain reason for the delay. 1/18/24: “ART (Arterial) BP NO COMM [communication]”. Per BMT: “Found plug on power logic bd not plug all the way reconnected bd no other problem found.” Completed on 1/22/24. 1/25/24: “Art BP NO COMMUNICATION” Per BMT: Could not duplicate. Completed on 2/8/24. 1/22/24: Heparin pump broke. Per BMT: Replaced Heparin pump with used one. Tested OK. Closed on 1/23/24. 1/29/24: “Keeps failing for negative pressure. Pulled it Saturday and was told it was fixed. So machine was pulled back on the floor. Machine failed x 4.” BMT “found split hose on inlet side of deaeration motor port replaced.” Machine repair completed/closed on 2/06/24. 2/12/24: “art BP co comm” No completion date; still active. 2/23/24: “TMP. tmp constantly alarming. Venous transducer gets bloody immediately after changing it. Can’t run pts at their prescribed BFR happened with every patient on this machine.” A review of Treatment Sheets showed the following: P#2’s treatment sheet dated 3/8/24 showed “DFR not meeting DFR due to machine issue, conductivity alarms if machine not at higher DFR. Order for new DFR for today’s tx [treatment] only received”. On 3/15/24 at 9:20 a.m., Clinic Manager stated, “Machine should have been taken out (off floor and not used).” A review of the Grievance File revealed the following: 5/26/23: C/O (Complaint of) TV not working FA (Facility Administrator) emailed ATOM, Biomed, DO (Director of Operations), and RVP (Regional Vice President) regarding the lack of TVs in working order. Final recovery 8/7/23. 8/9/23: Several patients are complaining about the TVs not working correctly, they have been unusable for several months. Date resolved: 8/16/23. Final service recovery: 1/30/24. 10/13/23: TV is not working and has not worked in over a year, he is here too long to not have a TV to occupy him during treatment. Resolved on 11/28/23. 10/16/23: Tired of not having a TV to watch during tx. New TV installed 11/28/23. 11/28/23 TV not working. Resolved on 11/28/23. 12/20/23: C/O about TV not working.”

“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: 03383 Based on observation and staff interviews, it was determined that the facility failed to ensure that 10 of 16 patients (P) (P#1, P#10, P#11, P#12, P#13, P#14, P#15, P#20, P#18, and P#19) on 3/12/24; six of 20 patients (P#2, P#21, P#23, P#24, P#26, and P#27) on 3/13/24; and five of 16 patients (P#10, P#12, P#28, P#29, and P#30) on 3/14/24 observed during dialysis treatment, had their vascular access sites uncovered/visible to the staff throughout dialysis treatment, to ensure patient safety. This deficient practice could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood). The facility census was 84 in-center hemodialysis patients. Findings were: During observation in the Patient Treatment Room on 3/12/24 between 8:15 a.m. and 8:50 a.m,, the following was revealed: - P#1, P#10, P#11, P#12, P#13, P#14, P#15, P#20, P#18, and P#19, who were seated at Stations (S) 1, 4, 6, 7, 9, 11, 12, 14, 15, and 20 respectively, had their access sites completely covered by a blanket. This surveyor informed LPN KK on 3/12/24 at 8:58 a.m. about covered accesses. LPN KK stated “We have told them to keep their access uncovered” and proceeded to inform three of the patients that their access must remain uncovered and removed cover from access. On 3/13/24 between 8:00 a.m. and 8:45 a.m., P#2, P#21, P#23, P#24, P#26, and P#27 who were seated at S2, S9, S13, S15, S17, and S18 respectively, had their access sites completely covered by a blanket. And again, on 3/14/24 between 8:15 a.m. and 8:30 a.m., P#10, P#12, P#28, P#29, and P#30 who were seated at S2, S6, S13, S14, S18 respectively, had their access sites completely covered by a blanket. The Clinical Manager (CM) was informed about covered accesses on 3/12/24 at 9:30 a.m., on 3/13/24 at 7:34 a.m., on 3/14/23 at 8:30 a.m. and during the exit conference on 3/15/24. The CM stated on 3/12/24 that she was told that if a patient signs a form that shows the patient’s refusal to keep access uncovered, then that was all that was needed. The Clinical Manager stated that it seems to be a culture here of patient’s covering their access.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 03383 Based on patient and staff interviews and review of facility records, it was determined that the governing body failed to ensure that the facility had sufficient qualified staff to meet the needs of all patients and provide safe patient care; and to be in compliance with the minimum state required staffing ratios of one licensed and qualified nurse for every 12 patients who were receiving dialysis care and one qualified patient care technician (PCT) for every four patients. This deficient practice had the potential to negatively affect the health and safety of 84 in-center hemodialysis patients who dialyzed at this facility. Findings were: During an interview on 3/12/24 at 9:02 a.m., Patient (P) P#2 stated there was no RN (Registered Nurse) here on Friday and had to come in on Saturday. During an interview on 3/12/24 at 3:45 p.m., P#3 stated “They have a staff shortage here; sometimes there is less staff, sometimes more; they are late putting me on dialysis; it happens often”. During an interview with the Clinic Manager (CM) on 3/12/24 at 2:13 p.m., the CM stated they were short in September and October of last year when patients from another dialysis clinic dialyzed here while a neighboring clinic was closed. Stated “We got their patients but no staff to care for them. Staffing is better now but we are still short when someone calls in. We use travelers and float staff and they are usually the ones who call out. We usually have two nurses with ratios of 12 patients to one nurse and four patients to one PCT. We have one full-time (FT) RN, one FT LPN (Licensed Practical Nurse), one Travel RN, and one Fresenius Float RN.” A review of Patient Grievances related to staffing issues showed the following: On 10/27/23: - P#41 did not receive treatment on 10/27/23. Clinic was unable to open due to having no RN. P#41 stated he was given no instructions as to what to do if he had any complications. CM spoke to patient on 11/01/23. Advised P#41 of situation with no RN and stated that he should have received instructions to go to the Emergency Department (ED) for any complications, and if none, then he could have been rescheduled on Saturday 10/28/23. P#41 went to ED on 10/27/23. On 10/30/23: - P#36 was upset about missing treatment on 10/27/23, when the clinic closed without proper notification. Complained about the same issue on 11/10/23. On 10/30/23: - P#3 and P#43 voiced concerns about missing treatment on Friday, 10/27/23 due to clinic closing without proper notice. On 11/10/23: P#25 was unhappy with shortened treatments and missed treatments due to shortage in staff. On 11/10/23: - P#42 was unhappy with shortened treatments and missed treatments due to shortage in staff. Patient #42 stated that he understands that there is a shortage with help but there should be a plan in place when things like this happens, so patients do not miss treatments or to have shortened treatments. P#42 stated that his life and other patients’ lives are at risk when this happens. Patient wants accountability. A review of the treatment records and staff schedule dated 3/9/24 revealed the following: Three patients did not show up. There were 19 patients on the first shift. - PCT DD was assigned to care for five patients (P#17, P#18, P#28, P#35, and P#44). - PCT LL was assigned to care for five patients (P#1, P#3, P#10, P#11, and P#12). - PCT II was assigned to care for five patients (P#13, P#14, P#29, P#32, and P#34). - PCT EE had 4 patients (P#15, P#16, P#30, and P#31). RN NN initiated dialysis treatment on P#30 and PCT EE terminated treatment. RN NN initiated dialysis treatment on P#35 and PCT DD terminated treatment. PCT DD initiated dialysis treatment on P#11 and PCT EE terminated treatment. RN CC and RN NN assisted with monitoring vital signs for P#10, P#11, P#12, P#29, P#34, and P#35. The CM was notified of the above findings on 3/15/24 at 8:15 a.m.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 03383 Based on patient and staff interviews and record review, it was determined that the facility failed to implement the facility’s internal grievance process as evidenced by a lack of documented steps taken to resolve 13 of 28 documented grievances (filed on 5/26/23, 8/09/23, 10/09/23 x 3, 10/13/23, 10/16/23, 10/27/23, 10/30/23 x 2, 11/10/23 x 2, and 12/20/23) in a timely manner. This deficient practice had the potential to negatively affect the health and safety of 84 in-center hemodialysis patients and seven home peritoneal dialysis patients who were under the care of this facility. Findings were: During an interview on 3/12/24 at 3:45 p.m., P#3 stated “I have been here for about two years and the TVs (televisions) are not working; this is the third time; TVs have not been working for at least a year and a half. I complained to maintenance; and once complained to someone outside the facility. He (Biomed Technician) tells staff what they need to do. They have problems with dialysis machines. They were having a lot of problems with Machine #10. They don’t do nothing when we complain about things around here. I filed a formal grievance, I called someone last year and nothing happened.” A review of the Grievance Status Report revealed the following: 5/26/23: P#36 complained of TV not working; FA emailed ATOM (Area Technical Operations Manager), Biomed, DO (Director of Operations), and RVP (Regional Vice-President) regarding the lack of TVs in working order. Final recovery 8/7/23. 8/9/23: Several patients are complaining about the TV’s not working correctly, they have been unusable for several months. Date resolved: 8/16/23; Final service recovery: 1/30/24. 10/9/23: P#3 was upset with new chair time. New time interferes with picking his son up from school. Resolved on 10/18/23. Was able to switch times with another patient. 10/09/23: P#40 has concerns about change in chair time. Patient states that the new chair time will interfere with his transportation. Patient rides with another patient to dialysis treatment. Resolved: 10/18/23. Patient was able to switch with another patient who needed a different chair time. 10/13/23: P#37 complained TV is not working and has not worked in over a year, he is here too long to not have a TV to occupy him during treatment. Resolved: 11/28/23. 10/16/23: P#38 complained of being tired of not having a TV to watch during tx (treatment). Date resolved: 11/28/23, a new TV was installed. 10/27/23: P#41 did not receive tx on 10/27/23. Clinic was unable to open due to having no RN (Registered Nurse). Patient states he was given no instructions as to what to do if he had any complications. CM (Clinic Manager) spoke to patient on 11/1/23. Advised patient of situation with no RN and stated that he should have received instructions to go to ED for any complications, and if none, then he could have been rescheduled on Saturday, 10/28. Patient went to ED on 10/27. Resolved on 11/1/23. 10/30/23: P#36 was upset about missing treatment on 10/27/23, after clinic was closed without proper notification. Date resolved: 11/1/23. Final recovery: 12/4/23. P#36 complained about same issue on 11/10/23. Open requisitions for new staff, one travel RN started on 11/6/23 and another will be starting on 11/30/23. 10/30/23: P#3 and P#43 voiced concerns about missing treatment on Friday, 10/27/23 due to clinic closing without proper notice. P#3 called corporate. Date resolved: 11/1/23. Open requisitions for new staff, one travel RN started on 11/6/23 and another will be starting on 11/30/23. 11/10/23: P#36 was upset about missing treatment on Friday 10/27/23 due to clinic closing without proper notice. Open requisitions for new staff, one travel RN started on 11/6/23 and another will be starting on 11/30/23. 11/10/23: P#25 is unhappy with shortened treatments and missed treatments due to shortage in staff. Open requisitions for new staff, one travel RN started on 11/6/23 and another will be starting on 11/30/23. 12/20/23: P#40 complained about TV not working. Final service recovery: 2/7/24. A review of the grievance policy stated: 1. FKC Staff promptly acknowledges and reports all patient grievances to the Nurse in Charge (or Team Leader) as soon as possible. 2. The Nurse in Charge (or Team Leader) meets with the patient to gather information and completes as many fields as possible on the Patient Grievance Status Report daily within 72 hours of being notified. 3. The CM reviews the Patient Grievance Status Report daily. For any new grievances, CM meets with the patient within five business days to acknowledge, investigate and address the grievance. Note: MSW or other staff may also assist in assessing and resolving patient grievances, as appropriate. 4. CM reports back to the patient when a resolution is attained or considered by the facility. The CM was notified of the above findings on 3/15/24 at 8:15 a.m. and did not provide documentation pertaining to staff’s adherence to the grievance policy.”