South Fulton 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), 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 Registered Nurse (RN AA) and two of two Patient Care Technicians (PCT AA, and PCT BB) observed, to 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 13 of 13 patients who were receiving hemodialysis treatment at Stations (S) (S1, S2, S4, S8, S9, S11, S13, S14, S15, S16, S17, S19 and S20), 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 52. Findings include: Cross Reference: V 250 - Failure of the facility to ensure that one of one Registered Nurse (RN AA) and two of two Patient Care Technicians (PCT AA, and PCT BB) observed, 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 52 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) and two of two Patient Care Technicians (PCT AA, and PCT BB) observed, verified the machine’s dialysate conductivity and pH, according to the manufacturer’s DFU and facility P&P.”

“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 interviews, a review of the manufacturer’s Directions for Use (DFU), 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 Registered Nurse (RN AA) and two of two Patient Care Technicians (PCT AA, and PCT BB) observed, to 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 13 of 13 patients who were receiving hemodialysis treatment at Stations (S) (S1, S2, S4, S8, S9, S11, S13, S14, S15, S16, S17, S19 and S20), 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 52. Findings include: During observation in the Patient Treatment Room on 9/29/25 between 10:20 a.m. and 12:47 p.m., the following was revealed: - RN AA initiated dialysis on patient (P) #1 at station S19 at 11:21 a.m., without testing the machine’s final dialysate conductivity and pH. - PCT AA initiated dialysis on P#2 at S10 at 11:32 a.m., without testing the machine’s final dialysate conductivity and pH. - PCT BB initiated dialysis on P#3 at S14 at 11:51 a.m., without testing the machine’s final dialysate conductivity and pH. During an interview on 9/29/25 at 12:28 p.m., PCT BB stated that she forgot to check the machine’s dialysate conductivity and pH prior to initiating P#3’s hemodialysis treatment. - On 9/29/25 at 12:33 p.m., RN AA acknowledged that the machine’s dialysate pH and conductivity were not checked at S19 prior to starting P#1’s hemodialysis treatment. - On 9/29/25 at 12:45 p.m., PCT AA confirmed that he did not verify the machine’s dialysate conductivity and pH at S10 prior to the initiation of P#2’s hemodialysis treatment. The Clinical Manager was notified of the above findings on 9/29/25 at 12:55 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: titled, “Testing Dialysate Conductivity and pH on the Fresenius 2008T Hemodialysis Machine”, stated: A. The SFD (South Fulton Dialysis) clinical staff will test the final dialysate conductivity with an independent meter and will test the dialysate pH before each dialysis treatment on the Fresenius 2008T machine in accordance with the manufacturer’s instructions for use and the SFD policy and procedure. - A review of facility Policy: titled, “Myron L D-6 Measuring Procedure”, stated: 5. Close the shunt door and allow dialysate to flow and fill the sample cup approximately ¾ full. 10. Rinse BOTH the pH/ ORP sensor well and the conductivity cell three (3) times with the dialysate sample meter IFU. 11. Because pH measurements require compensation, ALWAYS fill both the pH sensor well and the conductivity cell completely with the dialysate sample. 12. Refills the pH sensor well and the conductivity cell completely with the dialysate sample. Both the pH/ORP sensor well and the conductivity cell MUST be rinsed and filled at least three (3) times with the sample before each measurement is taken. 13. Press CON. Obtain and document the reading. 14. Press pH/ ORP parameter button obtain the pH reading. Document the reading displayed. According to 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 the next patient.”

“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 and Prevention (CDC) recommendations, and staff interview, it was determined that the Infection Control Committee failed to ensure that six of seven patients observed, who were seated at Station (S) 1, S8, S15, S16, S17, and S20 who held pressure to their access sites for hemostasis (stopping of the flow of blood) after dialysis, and one of four Patient Care Technicians (PCT AA) observed, did not perform hand hygiene (wash hands with soap and water or use an alcohol based hand sanitizer) after glove removal. This deficient practice had the potential for cross contamination and increased risk of infection and could affect 49 in-center hemodialysis patients who were dialyzing at this facility. Findings include: During observation in the patient treatment area on 4/2/25 between 9:55 a.m. and 10:44 a.m., the following was observed: - The patients who were seated at S1, S8, S15, S16, S17, and S20 held pressure to their access sites for hemostasis after dialysis treatment. They did not perform hand hygiene after removing gloves and prior to leaving the treatment area. The patients were not reminded by the staff to wash hands nor offered to use a hand sanitizer after glove removal. - PCT AA was observed during termination of dialysis treatment on a patient at S20 with gloved hands, removed gloves and without performing hand hygiene, donned a new pair of gloves and continued taking the patient off dialysis at S20. - PCT AA was observed during initiation of dialysis treatment on a patient at S10 with gloved hands, removed gloves and without performing hand hygiene, donned a new pair of gloves and continued initiating dialysis treatment at S10. According to CDC, 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. The Clinic Manager (CM) was informed about the above findings on 4/2/25 at 2:30 p.m. The CM stated that patients usually perform hand hygiene before leaving the treatment area and wasn’t sure why it wasn’t done during today’s observations. A review of undated Policy titled, “Hand Hygiene” showed the following: Hand hygiene will be performed using soap and water or alcohol-based hand rub in accordance with the activities in the table below: - Before entering or leaving the patient treatment area. - Before and after direct contact with patients. - Immediately after gloves are removed.”

“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: 03383 Based on a review of medical records, staff interviews, and review pof facility Policy and Procedures (P & P), it was determined that the Medical Director failed to ensure that all direct patient care staff, (Registered Nurses [RN] and Patient Care Technicians [PCT]) adhered to facility P & P pertaining to high blood pressure (BP) readings and rapid heart rates (HR), to ensure that three of three patients (P) sampled (P#1, P#2 and P#3) who experienced high BP readings or rapid HR before, during, and after dialysis treatment, received medical care and supervision appropriate to their dialysis needs. The professionally accepted clinical practice standards for volume status for an adult hemodialysis patient was euvolemic (normal volume of blood or fluids in the body) and BP below 140/90 mmHg {millimeters of mercury) before dialysis and below 130/80 mmHg after dialysis. This was based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations and the Measures Assessment Tool (MAT ) per Centers for Medicare and Medicaid Services (CMS) - Version 2.5. Uncontrolled BP in dialysis patients can lead to severe consequences such as increased risk of heart attack, stroke, and heart failure, as the damaged kidneys are unable to regulate fluid and BP effectively, making cardiovascular complications a major concern for dialysis patients. The facility census was 49. Findings include: A review of “Treatment Flowsheets” from 3/3/25 - 4/2/25 showed the following: P#1: On 3/26/25: - At 7:48 a.m., P#1’s BP was 186/107 mmHg. Treatment was initiated by LPN FF - At 8:02 a.m., BP was 180/109 mmHg. - At 8:32 a.m., BP was 189/109 mmHg. - At 8:53 a.m., BP was 198/114 mmHg. - At 9:06 a.m., BP was 214/116 mmHg. - At 9:28 a.m., BP was 200/117 mmHg. - At 10:04 a.m., BP was 199/118 mmHg. - There was a lack of documented interventions that addressed P#3’s elevated SBP readings per facility P & P and standing orders.. - The charge nurse (RN DD) and the MD were not notified of persistently high SBP and DBP readings.. On 4/2/25 at 1:40 p.m., the Clinic Manager (CM) confirmed that the Charge Nurse and the MD were not notified. P#2: On 3/7/25: - At 9:17 a.m., dialysis treatment was initiated by PCT AA. P#2’s HR was 124 beats per minute (bpm). - There was a lack of documentary evidence that the MD was notified of P#2’s rapid HR per facility’s standing orders. On 3/10/25: - At 8:36 a.m., P#2’s HR pre-treatment was 123 bpm. - At 9:06 a.m., during treatment, P#2’s HR was 122 bpm. - There was a lack of documentary evidence that the MD was notified of P#2’s rapid HR per facility’s standing orders. On 3/24/25: - At 10:39 a.m., dialysis treatment was initiated by PCT HH. P#2’s HR was 129 bpm. - At 10:59 a.m., P#2’s HR was 121 bpm. - There was a lack of documentary evidence that the MD was notified of P#2’s rapid HR per facility’s standing orders. On 4/2/25 at 1:45 p.m., the CM confirmed that the physician was not notified about P#2’s rapid HR per facility’s standing order. P#3: On 3/26/25: - At 6:07 a.m., BP was 185/77 mmHg. Treatment was initiated by RN EE. - At 6:25 a.m., BP was 196/70 mmHg. “Blood rinsed back b/cos (because) [sic] of water problem in the water room.” - At 8:01 a.m., BP was 186/73 mmHg . - At 8:31 a.m., BP was 196/70 mmHg. - At 9:01 a.m., BP was 210/75 mmHg. - At 9:08 a.m., BP was 204/72 mmHg. - At 9:15 a.m., BP was 212/73 mmHg. - At 9:31 a.m., BP was 205/66 mmHg. - At 10:41 a.m., BP was 207/74 mmHg. Treatment was ended. - There was a lack of documented interventions that addressed P#3’s elevated SBP readings per facility P & P. - The charge nurse (RN DD) and the MD were not notified of persistently high SBP readings.. On 3/28/25: - At 6:11 a.m.,P#3’s BP was 210/73 mmHg. Treatment was initiated by RN EE. - At 6:31 a.m., BP was 196/62 mmHg. - At 7:01 a.m., BP was 199/83 mmHg. - At 7:31 a.m., BP was 209/84 mmHg. - At 7:33 a.m., BP was 223/79 mmHg. BP rechecked. - At 7:34 a.m., BP was 209/71 mmHg. BP rechecked again. - At 8:01 a.m., BP was 216/72 mmHg. BP rechecked. Clonidine 0.1 mg give PO. - At 8:31 a.m., BP was 203/70 mmHg. - There was a lack of documented evidence that the MD was notified of P#3’s persistently elevated SBP readings. On 4/2/25 at 1:50 p.m., the CM confirmed that the MD was not notified about SBP > 200 per P & P and standing orders. A review of undated policy titled, “Blood Pressure Monitoring & Data Collection Pre -Intra-Post Treatment” showed the following: HYPERTENSION PROCEDURES: 1) Notify charge nurse if Systolic (top number) BP is greater than 200, or if Diastolic (bottom number) BP is greater than 100. Follow standing order protocol for hypertension. 2) DO NOT INITIATE DIALYSIS UNTIL YOU SPEAK DIRECTLY TO A NURSE if BP is outside BP parameter guidelines above. 3) Re-assess patient blood pressure every 30 minutes during treatment. More frequent monitoring may be necessary if complications arise during treatment, if patient becomes symptomatic or if blood pressure continues to trend outside parameter guidelines. - Refer to standing orders for blood pressure parameters management. Hemodialysis Standing Orders: - Hypertension: Pre and post tx (treatment) SBP (Systolic BP) > (greater than) 200 notify MD. Review meds and wt (weight) gain. During tx monitor BP, notify MD (physician) if hypertension persists or pt symptomatic. Post tx may give Clonidine 0.1mg po (by mouth) for SBP >200 or DBP (Diastolic BP) >100. May repeat x 1. Notify MD if BP still elevated after second dose. - Heart Rate: Pre/During/Post tx: Apical/ < (less than) 60 > 120, Notify MD.”

“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: 30300 Based on observation and staff interview, it was determined that the facility failed to ensure that there was a safe environment for eight of eight staff who were providing care at this facility, as evidenced by uneven floor surfaces and exposed concrete in one of one water treatment room. Findings include: During a tour of the facility on November 1, 2022 between 11:30 a.m. and 12:30 p.m., the following was observed: In the Water Treatment Room: - The floor throughout the room had uneven areas with exposed concrete creating a wavelike uneven surface. Thus had the potential for staff to trip or fall. During an interview on 11/3/23, at approximately 12:00 p.m., the Area Manager stated that the floor in water treatment room needed to be replaced.”

“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: 30300 Based on a review of facility records and staff interview, it was determined that the facility failed to adhere to facility policy partaining to fire drills for 12 of 12 months (10/1/22 - 10/1/23) of fire drill records reviewed. Failure to conduct periodic fire drills for each shift of patients, had the potential to negatively affect the health and safety of the 58 patients who were dialyzing at this facility. Findings were: A review of the facility fire drill records from 10/1/22 to 10/1/23, showed a lack of documented fire and evacuation drills for Tuesday, Thursday, Saturday shift of patients for the last twelve months. The last documented fire drill was completed on 3/1/23 for Monday, Wednesday and Friday shift patients only. A review of the policy titled, “Fire Emergency” dated 7/16/18 stated fire drills shall be performed quarterly for each shift of patients and staff. During an interview with the Facility Administrator on 11/1//23 at approximately 2:00 p.m., he stated that the fire drills should have been conducted quarterly.”