Hapeville 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 hemodialysis patients as evidenced by failure of one of one Registered Nurse (RN AA) and one of one Patient Care Technician (PCT AA) observed, to verify the machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU per AAMI RD52:2004 standard. This failure had the potential to negatively affect the health and safety of four of four patients (P) (P#5, P#4, P#7, and P#6) who were observed before and during the initiation of dialysis treatment. Incorrect dialysate composition can lead to a range of complications, from mild symptoms such as nausea and fatigue to more serious conditions like metabolic acidosis (a decrease in blood pH that may cause rapid breathing, confusion, dizziness, shortness of breath, or chest pain). And if conductivity is out of the acceptable range, the effectiveness of the dialysis treatment may be reduced, and impair patient treatment, alter electrolyte and fluid balance, and lead to serious health consequences. The facility census was 45. Findings include: Cross Reference: V 250 - Failure of the facility to ensure that one of one Registered Nurse (RN AA) and one of one Patient Care Technician (PCT AA) 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, a review of records, staff interviews, review of the manufacturer’s Directions for Use (DFU), facility Policy and Procedures (P&P) and minimum state required staffing ratios, 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 45 patients who dialyzed at this facility. Findings include: Cross References: V250 - Failure of the facility to ensure that one of one Registered Nurse (RN AA) and one of one Patient Care Technician (PCT AA) observed, verified the machine’s dialysate conductivity and pH, according to the manufacturer’s DFU and facility P&P. V757 - Failure of the Facility Administrator to ensure that the facility had adequate number of 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 giver for every four patients.”

“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 hemodialysis patients as evidenced by failure of one of one Registered Nurse (RN AA) and one of one Patient Care Technician (PCT AA) observed, to verify the machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU per AAMI RD52:2004 standard. This failure had the potential to negatively affect the health and safety of four of four patients (P) (P#5, P#4, P#7, and P#6) who were observed before and during the initiation of dialysis treatment. Incorrect dialysate composition can lead to a range of complications, from mild symptoms such as nausea and fatigue to more serious conditions like metabolic acidosis (a decrease in blood pH that may cause rapid breathing, confusion, dizziness, shortness of breath, or chest pain). And if conductivity is out of the acceptable range, the effectiveness of the dialysis treatment may be reduced, and impair patient treatment, alter electrolyte and fluid balance, and lead to serious health consequences. The facility census was 45. Findings include: During observation in the Patient Treatment Room on 12/17/25 between 10:26 a.m. and 12:15 p.m., the following was revealed: - PCT AA initiated dialysis treatment on P#5 at Station (S) 5 at 11:15 a.m., without testing the machine’s final dialysate conductivity and pH. - PCT AA was observed at 11:47 a.m., while she verified the machine’s final dialysate conductivity and pH at S7, using the Myron L D-6-meter (a portable, multi-parameter water quality meter, used to measure conductivity, pH...). PCT AA obtained a dialysate sample from the machine and proceeded to fill the Myron L meter with a sample and then immediately read the results. - RN AA initiated dialysis treatment on P#7 at S4 at 11:59 a.m., without testing the machine’s final dialysate conductivity and pH. - PCT AA initiated dialysis on P#6 at S3 at 12:02 p.m., without testing the machine’s final dialysate conductivity and pH. On 12/17/25 at 12:08 p.m., RN AA confirmed that she didn’t check the final dialysate conductivity and pH prior to the initiation of P#7’s treatment. RN AA stated that she was new to the facility and had been told that if the independent conductivity test had been completed earlier in the morning or prior to previous patient’s treatment, it did not need to be repeated. On 12/17/25 at 12:26 p.m., PCT AA stated she must have forgotten to check P#4’s and P#6’s final dialysate conductivity and pH. PCT AA also confirmed she collected a sample and filled the Myron L meter one time before reading the results for the patient at S7. The Area Manager was notified of the above findings on 12/17/25 at 5:30 p.m. A review of “Fresenius Medical Care 2008T Hemodialysis Machine Operator’s Manual” showed the following DFU: Page 10 - Recirculation Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g. using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment. Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If they are not, do not initiate dialysis. A review of facility Policy: DCC-IC-DM-960-007 titled, “Checking Conductivity and pH of Final Dialysate”, with latest revision date of May 28, 2020, showed: B. The final dialysate conductivity and pH must be tested prior to each patient’s treatment... A review of facility Policy: DCC-IC-DM-960-006 titled, “Myron L D-6 Measuring Procedures”, with latest revision date of October 26, 2020, showed the following: Measuring dialysate conductivity and pH: 3. Rinse both the pH/ORP sensor well and conductivity cell three (3) times with the dialysate sample per dialysate meter IFU. Note: Because pH measurements require temperature compensation, ALWAYS fill both the pH sensor well and conductivity cell completely with the dialysate sample. 4. Refill the pH sensor well and conductivity cell completely with the dialysate sample. Note: Both the pH/ ORP sensor well and the conductivity cell MUST be rinsed and filled at least three (3) times with sample before each measurement is taken. 5. Press COND. Obtain reading. 6. Pushes the pH/ ORP parameter button to test the pH. 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 the next patient.”

“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: 50523 Based on observation, review of records, staff interviews, a review of the manufacturer’s Directions for Use (DFU), and review of facility Policies and Procedures (P&P), it was determined that the facility failed to ensure that the required preventive maintenance (PM) were conducted on seven of 21 hemodialysis (HD) machines within the manufacturer-specified time frame; and that two of 13 hemodialysis machines in use, underwent and passed the required testing prior to the initiation of patients’ dialysis treatment. This deficient practice placed patients at risk for receiving dialysis treatments from equipment that may not function as intended, including risk of inaccurate ultrafiltration (removal of fluid), improper dialysate (dialysis fluid made of purified water mixed with specific electrolytes and minerals) delivery, failure of critical alarms, and unexpected equipment failure during treatment, potentially resulting in patient harm. The facility census was 45. Findings include: During observation in the Patient Treatment Room on 12/17/25 between 10:26 a.m. and 12:15 p.m., the following was revealed: - At Station (S) 8, HD machine 17 displayed a failed negative pressure test on the test screen and the same was displayed at S14, HD machine 6. At the time of observation, both machines were actively being used to provide hemodialysis treatment to patients. NOTE: A failed negative pressure test on a Fresenius 2008T means the machine couldn’t achieve or maintain the required vacuum in the dialysate circuit during its self-check, often signaling a leak in the dialyzer/lines, a problem with the deaeration pump, or issues with the membrane, preventing safe fluid removal and potentially leading to air in the blood, which requires immediate clinical attention for safety. A review of the facility’s “Preventative Maintenance logs” revealed the following: - HD machine 4’s semi-annual PM was done on 1/18/24 and the annual PM was done on 7/21/25. - HD machine 9’s semi-annual PM was done on 4/16/24 and the annual PM was done on 6/21/25. - HD machine 10’s semi-annual PM was done on 5/9/24 and the annual PM was done on 7/27/25. - HD machine 13’s semi-annual PM was done on 8/10/24 and the annual PM was done on 7/21/25. - HD machine 15’s semi-annual PM was done on 9/9/24 and the annual PM was done on 6/27/25. - HD machine 16’s semi-annual PM was done on 8/25/24 and the annual PM was done on 7/21/25. - HD machine 17’s annual PM was done on 7/3/24 and the semi-annual PM was done on 6/21/25. During an interview on 12/17/25 at 11:27 a.m., Patient Care Technician (PCT) BB stated that the negative pressure test frequently failed, requiring multiple attempts to retest the machines. PCT BB stated that when a machine failed the test after a third attempt, she would remove the machine from the treatment floor and obtain another machine for use. PCT BB also stated that this process had caused delays in initiating patient treatment, as all components of the test were required to pass prior to starting dialysis. On 12/17/25 at 3:15 p.m., the Biomedical Technician (BMT) stated that all complaints related to the HD machines were due to the machines failing pressure tests and displaying inaccurate readings for conductivity and bicarbonate levels. BMT stated that most of the machines were old, and new ones were supposed to be coming soon. The BMT further stated that he calibrated the machines therefore, the conductivity and bicarbonate levels were accurate. The BMT also stated he took over the facility in September 2025, and that he was not aware that PM for the seven hemodialysis machines were performed outside of the required time frame although each machine should have a PM done every six months. A review of “Fresenius Medical Care 2008T Hemodialysis Machine Operator’s Manual” showed the following DFU: Page 8 Six (6) month Preventative Maintenance Perform the following Preventive Maintenance procedures every six (6) months of machine operation. Page 18 Annual (4000 hour) Preventive Maintenance Perform the following Preventive Maintenance procedure every 12 months or 4000 hours of machine operation, whichever comes first. - A review of facility Policy: DCC-IC-BM-990-013 titled, “Preventive Maintenance Schedules for Equipment” with latest revision date of August 13, 2019, showed: 1. Preventive maintenance (PM) schedules must be made in accordance with the manufacturer’s recommendations for all equipment used to perform a patient treatment. - A review of facility Policy: DCC-IC-HD-250-004 titled, “Performing Pressure and Alarm Tests on the Fresenius 2008T Hemodialysis Machine” with latest revision date of August 13, 2017, showed the following: 4. Check the test box to ensure the message TEST COMPLETE appears in the Status box, indicating all tests were successfully completed. 5. An audible alarm will sound only if the tests failed. If the machines fails any test and the cause can be corrected, retest machines until all pressure and alarm tests have successfully passed. After three consecutive failed tests, notify Biomed and remove the machine from service.”

“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: 50523 Based on observation, a review of facility records, interviews, and a review of minimum state required staffing ratios, it was determined that the governing body failed to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients 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, other medical issues and emergencies, for every 12 patients receiving dialysis care; and that each care giver was not assigned more than four patients at any given time per the minimum state required staffing ratios. This deficient practice 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, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, delayed adjustments, or missed complications including but not limited to intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility census was 45. Findings include: During observation in the Patient Treatment Room on 12/17/25 from 10:26 a.m. - 12:15 p.m., the following was revealed: - The Patient Treatment Room had four Pods (sections) with four patient Stations (S) in each Pod. - Registered Nurse (RN) AA was assigned and cared for patients in S1, S2, S3, and S4. RN AA also conducted nursing assessments, prepared and administered medications, and performed other nursing tasks to patients in S5, S7, and S8, who were assigned to Patient Care Technician (PCT) AA. - RN BB was assigned and cared for patients in S13, S14, S15, and S16. In addition, RN BB also conducted nursing assessments, prepared and administered medications, and performed other nursing tasks to patients in S10 and S12. A review of “Patient and Teammate Schedule” (schedule of patients dialyzing each shift and the PCTs and licensed nurses providing patient care services) from October 2025 to December 2025, revealed the following: - On Mondays, Wednesdays and Fridays (MWF) schedule, there were three shifts with 16 patients on the first shift, 16 patients on second shift, and 13 patients on third shift. - The schedule revealed that the RNs functioned as patient care givers and provided total care to four patients in a Pod each shift. In addition, the RNs conducted nursing care/tasks including, but not limited to pre and post dialysis assessments, preparation and administration of medications, as well as overseeing the care of other patients who were assigned to PCTs. For example: - On 10/27/25 - three PCTs, two RNs. - On 11/3/25 - three PCTs, two RNs. - On 11/14/25 - three PCTs, two RNs. - On 11/17/25 - three PCTs, two RNs. - On 12/8/25 - two PCTs, two RNs. - On 12/12/25 - two PCTs, two RNs. - On 12/15/25- two PCTs, two RNs. - On 12/17/25 - two PCTs, two RNs. During patient interviews on 12/17/25 between 10:55 a.m. and 11:20 a.m., the following was revealed: - Patient (P) #1 stated that for the last few months, the facility had consistently experienced staffing shortages, which resulted in delays in initiating hemodialysis treatments. P#1 reported that she had raised this concern with the area manager, who informed her that efforts were underway to hire additional staff. P#1 also stated that the repeated treatment delays had interfered with her work schedule, noting that delays occurred during every session. P#1 emphasized the importance of her job to her. - P#2 stated that for the past couple of months, he had not received his hemodialysis treatments at his scheduled chair time due to not having enough Direct Patient Care (DPC) staff (Nurses and PCTs). P#2 also stated that his treatments were typically initiated at least 45 minutes after his scheduled time. - P#3 stated that she had consistently experienced significant delays before the initiation of her hemodialysis treatments. P#3 stated that no staff member had ever provided an explanation for the delays and stated that she had not voiced complaints because she did not want to cause trouble yet the consistent delays are inconvenient. During interviews with DPC Staff on 12/17/25 between 11: 37 a.m. and 12:15 p.m., the following was revealed: - RN BB stated that the staffing had been an issue for quite a while, and she added that it was overwhelming to be assigned to a Pod of four patients per shift, and to be responsible for four other patient’s medications and nursing assessments. - RN AA confirmed what RN BB stated above regarding the RN’s responsibilities. During an interview on 12/17/25 at 4:04 p.m., the Medical Director acknowledged the above findings.”

“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: 32734 Based on observation, staff interview, and a review of facility policy, it was determined that the infection control committee failed to ensure that one of one Patient Care Technician (PCT AA) observed, wore gloves when he touched the patient’s equipment and performed direct patient care; and performed hand hygiene (wash hands or use an alcohol-based hand sanitizer) when moving from a “dirty” area or task to a “clean” area or task. This failure increased the risk for cross contamination. The facility census was 40. Findings include: During observations of the treatment room on 11/1/24 at 12:30 p.m., PCT AA silenced the machine alarm (dirty task) and adjusted the patient’s fistula needle (clean task) at Station 13 without wearing gloves or performing hand hygiene between tasks. During an interview on 11/1/24 at 12:30 p.m., PCT AA stated,” I just came back from break and heard the machine alarming and just wanted to get to the patient to see what was wrong. I did not think about my PPE at the time”. A review of facility policy titled, “Personal Protective Equipment” issued January 6, 2016 with the latest revision date of December 9, 2019 showed the following: A. Staff will wear personal protective equipment (PPE) appropriate to the anticipated potential exposure. Refer to Exposure Task List contained in this policy & procedure. B. Staff will wear gloves, gown, face shields and eye wear, to protect themselves and prevent soiling of clothing when performing procedures where spurting or spattering of blood might occur.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 32734 Based on observation, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and staff interview, it was determined that the facility failed to ensure that one of three handwashing sinks in one of one Patient Treatment Room were in good working condition, to facilitate handwashing for patients who were coming in for their hemodialysis (HD) treatment and for those patients who had completed their HD treatment, all Direct Patient Care (DPC) staff and ancillary staff who interacted with the patients on the treatment floor. The facility census was 40. Findings include: During a tour of the Patient Treatment Room accompanied by the Clinical Manager (CM) on 10/30/24 between 10:30 a.m. and 12:30 p.m., one of three sinks designated as “clean” sink used for handwashing by the staff and patients, did not have warm running water for handwashing. The water in the sink failed to warm up after running for more than three minutes. According to CDC, handwashing is the most important measure to prevent contaminant transmission. During an interview with the CM on 10/30/24, the CM acknowledged the findings.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 32734 Based on observation, staff interview, and a review of facility policy, it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT AA) observed, wore personal protective equipment (PPE) when appropriate. This failure increased the risk of soiling PCT AA’s clothing and exposure to blood and other potentially contaminated substances. Findings include: During observation in the patient treatment room at 12:30 p.m. on 11/1/24, the following was revealed: - During the process of adjusting the fistula needle during dialysis treatment on a patient with an arteriovenous fistula (dialysis access) who was seated at Station 13, PCT AA failed to wear a gown, goggles or a face shield during the procedure. During an interview on 11/1/24 at 12:30 p.m., PCT AA stated, “I just came back from break and heard the machine alarming and just wanted to get to the patient to see what was wrong. I did not think about my PPE at the time”. A review of facility policy titled, “Personal Protective Equipment” issued January 6, 2016 with the latest revision date of December 9, 2019 showed the following: A. Staff will wear personal protective equipment (PPE) appropriate to the anticipated potential exposure. Refer to Exposure Task List contained in this policy & procedure. B. Staff will wear gloves, gown, face shields and eye wear, to protect themselves and prevent soiling of clothing when performing procedures where spurting or spattering of blood might occur.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 32734 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and review of facility policy, it was determined that the facility failed to ensure that one of one Registered Nurse (RN BB) observed during initiation and termination of hemodialysis (HD) treatment on one of one patient seated at Station (S) 6 who had a Central Venous Catheter (CVC - A flexible tube that was inserted into a vein, and threaded into a large vein), utilized appropriate infection control techniques to prevent cross contamination. This breach in infection control techniques could negatively affect the health and safety of the patient seated at S6, and all other patients who had CVC, as their dialysis access. The facility census was 40. Findings include: An observation in the Patient Treatment Room on 10/30/24 between 10:00 a.m. and 2:00 p.m., revealed the following: On 10/30/24 at 1:45 p.m., RN AA was observed during initiation of hemodialysis treatment on a patient who had a CVC at S6. - RN AA cleaned the CVC site starting from the inside closest to the exit site using an alcohol pad (clean to dirty). RN AA used the same antiseptic swab to clean from the outside of the exit site back towards the clean site. - RN AA scrubbed the hubs (plastic caps used to close the opening of the catheter lines) for approximately 3-5 seconds. - RN AA picked up the clip board located on the side of the machine, documented on the form, set the blood pump rate, flipped the dialyzer (artificial kidney), and moved the machine (dirty tasks). She then connected the bloodlines to the CVC lines (clean task) while she wore the same (contaminated) gloves. RN AA failed to change gloves between tasks. During an interview on 10/30/24 at 1:45 p.m., RN AA acknowledged that she touched the machine and stated, “I thought I changed my gloves”. According to the CDC, cross contaminating (going from dirty to clean equipment/tasks/area), could cause the spread of bacteria/infections. A review of Policy titled, “Initiating Dialysis Treatment with a Central Venous Catheter using ClearGuard HD Antimicrobial End Caps” issued January 6, 2016 with the latest revision date of August 14, 2024 showed the following: C. A 15-30 second 70% alcohol scrub must be performed on CVC hubs with every connection and disconnection during initiation, duration, and termination of treatment. VI. Procedure: - Perform hand hygiene to prevent contamination and spread of infection. Don appropriate PPE (staff): gown, face-shield, mask, and gloves.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 32734 Based on observation, staff interview, and a review of facility policy, it was determined that the facility failed to ensure that one of one registered nurse (RN BB) observed during initiation of dialysis treatment on one of one patient (P) (P#1) who had vascular access site located in his left groin, was treated with dignity and respect during initiation of dialysis treatment. This failure allowed P#1’s underwear and part of his genitalia to be exposed to other patients in the Pod (small group of four). Findings include: During observation in the Patient Treatment Room on 11/1/24 between 10:30 a.m. and 11:30 a.m., the following was revealed: - P#1, who was seated at Station 10 had his dialysis treatment initiated via a Central Venous Catheter (CVC - A flexible tube inserted into a vein, and threaded into a large vein) located in his left groin per RN BB. - RN BB failed to place a drape across the patient or use a privacy screen around the patient which allowed his underwear and part of his genitalia to be exposed to other patients in the Pod (small group of four). During an interview on 11/1/24 at 10:30 a.m. with RN BB, this surveyor asked why a privacy screen was not used to minimize his exposure. RN BB stated, “I normally put a screen around him”. RN BB retreived the privacy screen and placed it around the patient and proceeded with the initiation of his treatment. A review of undated Policy titled, “Patient’s Rights and Responsibilities/Facility Rules” showed the following: You have the right of respect and dignity from your caregivers: Be treated with courtesy, consideration, and respect.”

“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: 32734 Based on a review of minimum state required staffing ratios, facility records, and staff interviews, 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 40 patients who dialyzed at this facility. Findings include: A review of staff assignments and “Patient and Teammate Schedule/Daily Assignments” for the third shift from 10/16/24 to 10/30/24 revealed the facility had four Pods with four Stations (S) in each Pod. Staffing consisted of one Patient Care Technician (PCT BB) and one Registered Nurse (RN BB), assigned to care for eight to ten patients across four Pods. At least one patient in each Pod had a Central Venous Catheter (CVC - A flexible tube inserted into a vein and threaded into a large vein above the right side of the heart) access, which required initiation and termination of dialysis and catheter care by an RN or Licensed Practicle Nurse (LPN). On 10/16/24 through 10/25/24 (Monday-Wednesday- Friday, third shift): - PCT BB and RN BB were assigned to care for 10 patients (at S2, S3, S5, S7, S9, S10, S11, S13, S14, and S15. - Four of 10 patients had CVC. - In addition to four CVC patients, RN BB also had to fulfill the responsibilities of a charge nurse such as pre and post nursing assessments, preparation and administration of all medications, monitoring of all patients throughout dialysis treatment, nursing interventions related to abnormal findings and emergencies, and other charge nurse’s responsibilities. On 10/28/24 through 10/30/24 (Monday and Wednesday, third shift): - PCT BB and RN BB were assigned to care for nine patients (at S2, S4, S5, S7, S10, S11, S13, S14, and S15. - Three of nine patients had CVC. - In addition to three CVC patients, RN BB also had to fulfill the responsibilities of a charge nurse such as pre and post nursing assessments, preparation and administration of all medications, monitoring of all patients throughout dialysis treatment, nursing interventions related to abnormal findings and emergencies, and other charge nurse’s responsibilities. During an interview on 10/30/24 at 2:30 p.m., RN BB stated “Staffing on third shift is not safe. It is just me and a PCT scheduled for eight to ten patients, and sometimes more if a patient has a rescheduled or extra treatment. I feel overwhelmed and that I am putting patient’s safety in jeopardy. Some days I can hardly keep up and do all the things I am supposed to do like administer medications, do pre and post assessments, put on patients with a CVC. We have had occasions when a patient had prolonged bleeding after treatment and the PCT was with him 1:1, leaving me to monitor the other seven or nine patients. It is too much”. During an interview on 10/31/24 at 12:35 p.m., PCT BB stated “I usually work the third shift with RN BB. Most of the time we can handle it if nothing goes wrong. It is harder to manage when you work with a nurse that does not have a lot of experience because you are constantly trying to tell them how to troubleshoot a machine issue or something like that, while still trying to take care of all the patients. It gets even harder if the nurse gets tied up with a patient. One nurse usually leaves around 6:00 p.m. Most of the time that leaves me and the other nurse with six patients, if they do not add any to the schedule. As the PCT, I end up taking care of all six patients unless they have a CVC”. During an interview on 11/1/24 at 3:00 p.m. with the Clinical Manager (CM), the CM stated, “The current third shift census is eight patients. We had four patients to transition to the second shift after their CVC was removed. We normally admit all new patients to the third shift and most of them usually have a CVC. RN AA was scheduled to work with RN BB and leave between 4:30 p.m. and 6:00 p.m., once the census was down to six patients or less”. A review of the “Daily Assignments/Patient Schedule” did not show that RN AA worked those hours. Staff assignments were not clearly designated.”

“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: 49321 Based on observation, staff interviews and record review, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was maintained free from damage and defects to ensure safety for all patients and staff. This failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth; and uneven, wet floorboards had the potential for patients and staff to slip and fall. This deficient practice was observed in one of one Patient Treatment Room, and in one of one Patient Lobby and hallway. Findings include: During a tour of the facility on 3/1/24 between 12:30 p.m. and 1:15 p.m., the following was revealed: In the Patients’ Lobby and Hallway: - The wood floor planks or floorboards were deeply scratched with dark spots and with brownish to blackish discoloration that covered the entire floor surface. In the Patient Treatment Room: - The whole floorboards were deeply scratched and discolored with brownish to blackish discoloration. - The baseboards behind Station (S), (S1), was missing, exposing a disintegrated drywall with a soft porous surface and a cardboard-like material was separating off the wall which extended approximately 7-8 feet length. The floorboards were scratched and with brownish discoloration. - At Stations, (S4, S5, S7, S11, S12, S15, and S20), the seams between the floor boards were warped, bulging, and coming up off the subfloor. In addition, the baseboard behind S4 was separating from the wall exposing a whitish, powdery substance from the drywall. - The floor between Stations, (S7, S9, S10 and S11), had visible moisture and when this surveyor stepped on them, there was a muddy substance seeping through the seams. In addition, at S11, there was a dry, thick, grayish-colored substance coming up off the seams of eight floor panels which also partly covered these floor panels. - At S7, the base board was missing and the wall above the floorboard, was peeling off exposing the powdery substance of sheetrock or drywall which was soft to touch and hollow. The pipes on the wall were also exposed. There were a few gnats coming out from this wall area. - The Wall Boxes and Drains (which are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products), at Stations, (S2, S3, S4, S10, S12, S13, S14, S15, S16, S17, and S18) had dried sediments with discoloration around the drains which ranged from whitish, tan, yellowish to orange/brown discoloration. In addition, the floor under the Wallbox at S15 had dried whitish to brownish sediments. - There were deep, scratched marks on the wall between Stations (S12 and S13). - The floor drains at Stations (S2, S13, and S17), were covered with dried, greenish and orange sediments. - The countertops of the dirty sink facing the Nurses’ Station were flaking and the floor panels under this dirty sink were separating and five of the floor panels were covered with a dark, green film. During Staff interviews on 3/1/24 between 1:00 p.m. and 2:00 p.m., the following was revealed: - Patient Care Technician (PCT AA) stated at 1:00 p.m., that the facility was supposed to be getting new floors but he didn’t know when. - Registered Nurse (RN AA - Charge Nurse) stated at 1:15 p.m., that yes, they were aware of the issues on the floor, walls, drains... - The Clinic Manager stated at 2:00 p.m., that the Regional Operations Manager was working on getting new floors. She also added that the Plumber came out and cleaned the drains and is spraying them weekly on Tuesdays to control the gnats. - The Regional Operations Manager stated at 6:10 p.m., that the floors, the wall boxes and drains, and the countertops will be repaired and changed out soon. A documentary evidence was presented that a Pest Control company had been coming to the facility to treat and control the gnats in the wall boxes and drains. - The Area Manager stated on 3/1/24 at approximately 6:05 p.m., that the above issues were assessed by a contractor with the estimated labor and materials, approximately one and a half to two weeks ago, but had not submitted the paperwork yet. - The Director of Quality, Compliance and Regulatory Affairs submitted a documentary evidence (via email), of the total estimate and established contract between both parties (contractor and facility/company), on 3/5/24, for the work to be initiated and completed.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 49321 Based on a review of the facility’s Policy and Procedure (P&P) and staff interviews, it was determined that the Medical Director failed to establish, adopt and annually review facility P & P in accordance with acceptable standards of practice as recommended by the Centers for Disease and Control Prevention (CDC) to ensure patient safety. This deficient practice affected Patient (P#1) and her family, and had the potential to negatively affect the health and safety of the other 39 patients who were under the care of this facility: Findings include: During a review of P#1’s medical records, the following was revealed: P#1’s Treatment Flowheets dated 1/22/24, stated: - Pre-assessment by Registered Nurse (RN AA) stated normal respirations, alert and oriented x3, no problems... Blood Pressure (BP) reading at 5:45 a.m. was 86/45. BP reading at 5:49 a.m. was 96/45. P#1’s hemodialysis treatment was initiated at 5:57 a.m. BP readings between 6:34 a.m. and 7:34 a.m. ranged from 95/51 and 110/57. At 8:08 a.m., BP reading was 91/50, then at 8:35 a.m., BP reading was 84/40. P#1 was given 300 mL (milliliter) of Normal Saline Solution at 8:36 a.m. and BP reading was 89/47. P#1 was discharged from the facility at 9:05 a.m. via Emergency Medical Services (EMS)/911. A review of RN AA’s late entry note dated 1/24/24 for 1/22/24 Nurse’s Note, stated: P#1 had low BP, bradycardia (slower than normal heart rate), chest pain and “going in and out”. - A review of the hospitalist’s History and Physical (H & P) and discharge summary of P#1 stated that P#1 was admitted to the hospital’s Emergency Department (E.D.) on 1/22/24 at 10:39 a.m., with the same admission and discharge diagnosis of: Acute hypoxemic respiratory failure, Cardiogenic shock and Sepsis. P#1 was pronounced deceased at 1656 hours (4:56 p.m.). The hospital report stated that the family was notified. - According to P#1’s family report, P#1 had died when they got to the hospital shortly after they were notified. During Staff Interviews on 3/1/24 between 3:57 p.m. and 5:40 p.m., the following was revealed: - RN AA stated at 3:57 p.m., that she called the Medical Director (MD) about P#1’s condition on 1/22/24 at 8:30 a.m. and was instructed by MD to send P#1 to the Emergency Room (E.R.). RN AA stated that she called 911/EMS (Emergency Medical Services) and P#1 was discharged from the facility via EMS at 9:05 a.m. RN AA also stated that usually when EMS came, they would assess a patient in their ambulance truck and RN AA would inquire from the EMS personnel which hospital E.R. the patient would be taken to. But on 1/22/24, P#1 was assessed by EMS personnel at P#1’s hemodialysis chair, (after convincing P#1 to go to the E.R.), then they just “scooped her up and took her out, I was not able to ask which hospital E.R. they were taking her to and sometimes in the past, EMS would say it depends on hospital E.R. availability”. RN AA confirmed that she was not able to notify the family and she didn’t ask anyone else in the facility to call the family. RN AA also added that P#1’s family called the facility at 4:00 p.m. on 1/22/24 to inquire where P#1 was because they could not reach P#1 via telephone and they didn’t find her at her house after they asked assistance from the police department. - The Clinic Manager stated at 4:59 p.m., that she could not recall if RN AA notified her about P#1 on 1/22/24, but she did see the Adverse Occurrence Report (AOR) for P#1 on 1/22/24. She added that AORs when submitted by Staff, would automatically pop up on her computer screen. She also added that RN AA did not ask her to call the family. - Patient Care Technician (PCT AA), who took care of P#1 on 1/22/24, stated at 5:30 p.m., that he was at lunch break when the event occurred and he was not asked to call the family. PCT AA added that the Administrative Assistant or the Nurse usually called the family. - The Clinic Manager was not able to provide a facility Policy and Procedure regarding Emergency notification or protocol. She stated on 1/22/24 at 5:15 p.m., that the facility did not have an Emergency Notification Protocol or P & P.”