Snellville Dialysis Center

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50523 Based on observation, staff interviews, a review of the manufacturer’s Directions for Use (DFU) and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of one of one Registered Nurse (RN AA) observed, to correctly verify the machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU and facility P&P. This failure had the potential to negatively affect the health and safety of 10 of 10 patients who were receiving hemodialysis treatment at Stations (S) 1, S2, S4, S7, S10, S11, S12, S13, S14, and S15 at the time of observation. 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. And if conductivity is out of the acceptable range, the effectiveness of the treatment is reduced and patient electrolyte balance could be altered. The facility census was 50 . Findings include: Cross Reference: V 250 - Failure of the facility to ensure that one of one Registered Nurse (RN AA) observed, correctly verified the machine’s dialysate conductivity and pH, according to the manufacturer’s DFU and facility P&P.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on observations, staff interviews, a review of facility records, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedures (P & P), 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 50 patients who dialyzed at this facility. Findings include: Cross Reference: V 250 - Failure of the facility to ensure that one of one Registered Nurse (RN AA) observed, correctly verified the machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU and facility P & P.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 50523 Based on observation, staff interview, and a review of facility Policy and Procedures (P & P), it was determined that the Infection Control Committee failed to ensure that two of two Patient Care Technicians (PCT AA and PCT BB), one of one Licensed Practical Nurse (LPN AA), and two of two Registered Nurses (RN AA and RN BB) observed, failed to ensure that clean equipment/areas were separated from dirty equipment/areas. This deficient practice increased the risk for cross contamination with the potential to expose all 50 in-center hemodialysis patients who were receiving hemodialysis services at this facility and all Direct Patient Care staff (nurses and PCTs), to bloodborne pathogens in the dialysis environment. Findings include: During observation in the Patient Treatment Room on 5/21/25 from 10:11 a.m. to 12:01 p.m., the following was revealed: - There were no labeled clean sinks (designated for hand washing) nor labeled dirty sinks (designated for draining used saline bags, draining prime buckets, contaminated clamps, etcetera - etc.). - An unlabeled sink was located right behind Station (S)14, which was touching the back end of the right side armrest of the hemodialysis chair (dirty) at S14. At 10:28 a.m., PCT AA was observed washing her hands on this unlabeled sink behind S14. - During an interview with RN AA on 5/21/25 at approximately 10:45 a.m., RN AA stated that the unlabeled sink behind the hemodialysis chair at S14 was designated as a clean sink. RN AA also added that there were two designated unclean sinks (unlabeled) and one clean sink (unlabeled), in the Patient Treatment Room. - A rolling three-shelf, black cart with both clean and dirty supplies, such as: used blue clamps in a bleach water plastic container [unlabeled], blue clamps in a plastic container [unlabeled], disinfectant bottles, a measuring cup, a large syringe, a prime bucket, red and blue wands (used to connect to a dialysate jug), white clamps, and other items (mostly unlabeled), was located right next to the patient’s hemodialysis chair at S14 (approximately six inches from the right armrest of the hemodialysis chair). In addition to potential for cross contamination, there was also the potential for the patient at S14 to be splashed with the bleach and bleach water from this cart. - A clean supply storage cabinet was located approximately 2 feet and 4 inches away from S11 (dirty). - A clean supply storage shelf was located approximately 1 foot 6 inches away from Station S17 (dirty). - The close proximity of the clean supplies to the patient stations had the potential for cross contamination and splashes of body fluids or blood from the patient during hemodialysis. - The Chief Operating Officer was notified of the above findings on 5/21/25 at 2:36 p.m. A review of facility Policy: IC-002 titled, “Universal Precautions: Environment Designations” showed the following: Definitions: Clean Area: Location where medications are prepared, sterile supplies are stored, and no contamination is expected. Contaminated Area: Any location exposed to blood, bodily fluids, used supplies/ equipment, or wasted handling. 1. Sinks: “ Handwashing sinks must be clearly labeled: “Hand Hygiene Only - Do Not Use for Equipment or Waste.” “ Utility or dirty sinks must be labeled: “Contaminated Use Only - Do Not Use for Hand Hygiene or Medication Prep” 2. Area Labeling and Separation: “ Clean areas must be separated from contaminated areas by physical barriers, distinct signage, or distance (minimum 3 feet when physical barrier is not possible).”

“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: 50523 Based on observation, staff interview, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedures (P & P), 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 Registered Nurse (RN AA) observed, to correctly verify the hemodialysis (HD) machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU and facility’s P & P. This failure had the potential to negatively affect the health and safety of 10 of 10 patients who were receiving hemodialysis treatment at Stations (S) 1, S2, S4, S7, S10, S11, S12, S13, S14, and S15, at the time of observation. 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. And if the conductivity is out of the acceptable range, the effectiveness of the treatment could be reduced and patient electrolyte balance could be altered. The facility census was 50. Findings include: During observation in the Patient Treatment Room on 5/21/25 between 10:11 a.m. and 12:01 p.m., the following was revealed: - RN AA was observed at 10:55 a.m., verifying the machine’s final dialysate conductivity and pH at S8, using the Myron L Ultrameter II 6P (a portable, multi-parameter water quality meter, used to measure conductivity, pH...). RN AA obtained a dialysate sample from the machine and proceeded to fill the Ultrameter with one sample then immediately read the results. - RN AA was observed at 11:20 a.m., verifying the machine’s final dialysate conductivity and pH at S13, using the Myron L Ultrameter II 6P. RN AA repeated the same incorrect procedure as mentioned above. During an interview on 5/21/25 at 1:25 p.m., RN AA stated that she always collected a sample and filled the Ultrameter one time before reading the results. -The Chief Operating Officer was notified of the above findings on 5/21/25 at 2:38 p.m. -A review of the manufacturer’s DFU on the “Myron L Ultrameter (Trademark) II 6P”, showed the following: Page 9-10 V. SPECIFIC RECOMMENDED MEASURING PROCEDURES A. Measuring Conductivity & Total Dissolved Solids (TDS) 1. Rinse cell cup 3 times with sample to be measured. (This conditions the temperature compensation network and prepares the cell.) 2. Refill cell cup with sample. 3. Press COND or TDS. 4. Take reading. C. Measuring pH (6PFCE) 1. Remove protective cap by rotating while grasping and pulling up. 2. Rinse pH/ORP sensor well and conductivity cell cup 3 times with sample to be measured. Shake out each sample to remove any residual liquid. 3. Refill both sensor well and cell cup with sample. 4. Press pH. 5. Note value displayed A review of facility Policy: E-Tec-203 titled, “Ultrameter (Trademark) Model 6P Procedure”, stated: 5. Procedure A. Daily Use- Dialysate Testing 1. Rinse the Ultrameter’ s conductivity and pH sensors three (3) times using dialysate from the blue Hanson port of the dialysis machine. 2. Refill the sensor with the dialysis. 3. Press COND to measure conductivity. 4. Press pH to measure dialysate pH.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 50523 Based on observation, staff interview, a review of the facility’s Policy and Procedures (P&P) and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was clean and maintained free from damage and defects to ensure the safety of the patients and staff. Unsanitary environments and excessive moisture could contribute to mold growth on surfaces and materials that could cause various respiratory issues, including allergic reactions, asthma attacks, and infections. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thereby creating a potential environment for microbial growth. These environmental concerns were observed in one of one Patient Treatment Room, in one of one Supply Room, and in one of one Dialysate Preparation Room. The facility census was 50. Findings include: During observation on 5/21/25 from 10:11 a.m. to 12:01 p.m., the following was revealed: In the Patient Treatment Room: - The wood plank floor tiles (approximately 9.7 feet in length), from Stations (S) S5, S6 to S7, were detached from the concrete subfloor. Standing water was observed both on top of the wood planks and on the underlayment that was placed between the wood plank floor tiles and the concrete subfloor. In the Storage Room: - A section of the tile flooring in front of the delivery door (used for receiving supplies and equipment), had missing tiles, approximately five feet length by five feet wide. - A section of the tile flooring (approximately three feet length by two feet wide), that was under and around a wooden palette of supplies, had missing tiles. In the Dialysate Preparation Room and Storage Room: - The floor behind a large Reverse Osmosis (R.O.) Water Holding Tank, behind the Booster Pump, and behind the Chemical Storage and Mixing Tank, was covered with a dark, dried, dirt-like substance mixed with a red-orange colored residue. -The floor behind the Multimedia Filter, Carbon Filter, Water Softener, and R.O. system, was covered with a dark, dried, dirt-like substance. The above findings were confirmed with the Chief of Operations and Director of Operations (DO) on 5/21/25 at 2:31 p.m. A review of facility Policy: ENV-101 titled, “Physical Environment and Water Room Sanitation” showed the following: 4.1 Building Maintenance Areas accessed by patients and staff must be inspected regularly for: “ Flooring or wall damage “ Leaks, mold, or pest activity 5.1 Water Treatment Room Standards “ Floors must be swept/mopped daily using appropriate disinfectants. “ Surfaces, tanks and RO units must be wiped daily: deep cleaned weekly. “ Standing water, microbial growth, or visible contamination must be reported and corrected immediately. According to the CDC, it is important to address moisture issues in buildings to prevent mold and mildew growth, which can be harmful to human health. Standing water in these areas can create a breeding ground for mold and mildew, leading to various issues.”

“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: 50523 Based on staff interview and a review of facility Policy and Procedures (P&P), it was determined that the Medical Director failed to ensure that all facility staff ( nurses, patient care technicians, Social Worker, Chief Operating Officer...), adhered to the facility’s P&P relative to Patient Complaint and Grievance Protocol for one of one patient (P) (P#1), sampled. This deficient practice had the potential to negatively affect the health and safety of P#1 and all the other 49 patients who were under the care of this facility. Findings include: A review of the facility’s Complaints and Grievance Logs between December 2024 to May 2025 showed that there were no grievances reported/documented related to concerns about the quality of care provided. When this surveyor asked facility staff on 5/21/25 at 2:38 p.m., whether any verbal complaints or grievances had been expressed regarding dissatisfaction with the facility’s care, the following information was revealed: - On 5/21/25 at 2:45 p.m., Registered Nurse (RN AA) stated that on 3/21/25, P#1 was picked up late by his daughter from the lobby following hemodialysis treatment. RN AA explained that the facility staff were unaware P#1 had soiled himself, as he did not communicate this to them. The staff was later informed of the incident by the Chief Operating Officer (COO). - The Director of Operations stated on 5/21/25 at approximately 2:50 p.m., that there were no grievances related to the complaint that was documented. - On 5/21/25 at 2:52 p.m., the COO reported that the daughter of P#1 called her regarding concerns that P#1 had soiled himself while waiting to be picked up after his hemodialysis treatment on 3/21/25. The COO stated that the daughter had called to express dissatisfaction with the care her father received at the facility. In response, the COO stated that she held a staff huddle to address and discuss the reported incident. -There was no documentary evidence that a complaint or grievance report was filed or documented on P#1’s behalf. There were no documentary evidences of a resolution and staff training or in-services regarding the complaint in order for it not to happen again. There was no documentary evidence that the patients were educated/re-educated regarding Complaint and Grievances, nor communication regarding resolution. There was no documentary evidence that P#1 or representative were notified of the resolution. - A review of facility Policy: titled, “Patient Complaint and Grievance and Resolution” showed the following: 1. Patient may give complaint in writing or in verbal form. 2. This complaint is conveyed to chain of command for proper resolution. Follow the chain of commands for the grievances or any problems. a. Medical Director b. Assistant Medical Director c. Administrator Complaint with problem is to be delivered to the person in ascending order. 3. Patient/ representative will be notified about resolution outcome in expeditious way but no later than two business weeks.”