Davita Arbor Place Dialysis

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 52051 Based on a review of facility records, staff interview, and a review of facility Policies and Procedures (P & P), it was determined that the facility failed to ensure that all staff members including but not limited to: the Facility Administrator (FA/RN AA), the Assistant Facility Administrator (Staff AA), Registered Nurses (RN BB and RN CC), Patient Care Technicians (PCT AA, PCT BB and PCT CC), Biomedical Technician (BMT), Social Worker (SW), and Registered Dietitian (RD), and all 43 patients, had participated in a quarterly fire and evacuation training or drills as required. This failure posed a potential risk to the health and safety of both staff and patients during an emergency, as untrained individuals may not know how to respond appropriately in the event of a fire. The facility in-center patient census was 43. Findings include: During a review of the facility’s Emergency Preparedness Plan records, it was revealed that there was no documented evidence that quarterly fire drills had been conducted with either staff or patients, as required. During an interview with the Assistant Facility Administrator (Staff AA) on 8/28/25, at 8:16 a.m., she stated that fire drills were being conducted on a quarterly basis in the facility and mentioned she would look for fire drills documentation. A review of Policy: 4-07-01, titled, “Facility Emergency Management Plan”, last revised October 2, 2024, stated: Fire Safety Preparedness 1. FA, or designee, is responsible to: b. Conduct and review quarterly fire safety and evacuation training and drills for compliance, identify additional training and education needs. 3. Fire Safety Drills: b. Required on a QUARTERLY basis c. One drill to be conducted for each shift of patients f. Document training for both teammates and patients On 8/28/25, at 11:00 a.m., this surveyor followed up with Staff AA regarding the documentation for the quarterly fire drills. Staff AA mentioned that the records were being maintained by the Administrative Assistant (Staff EE). Staff AA also mentioned that she attempted to call Staff EE, but there was no response. Staff AA was not able to provide the quarterly staff’s’ and patients’ Fire Drills documentation during the exit interview on 8/28/25 at 12:10 p.m.”

“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: 52051 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility Policies and Procedures (P & P), it was determined that the facility failed to ensure that one of one Registered Nurse (RN CC), observed on the first day of the survey, and one of one Patient Care Technician (PCT CC) and two of two patients at Stations (S)10 and S11, observed on the second day of the survey, consistently performed hand hygiene (handwashing with soap and water or use of an alcohol-based hand sanitizer), after removing contaminated gloves, between glove changes, and after touching contaminated area/equipment. This breach in infection control techniques, such as hand hygiene, had the potential to increase the risk for cross contamination with the potential to expose patients and staff to bloodborne pathogens in the dialysis environment. The facility census was 43. Findings include: 1. During observation in the Patient Treatment Room on 8/26/25 from 9:42 a.m. to 11:45 a.m., the following was revealed: - At 9:54 a.m., RN CC was observed taking the Intradialytic Parenteral Nutrition (IDPN - a specialized form of nutritional support given directly to hemodialysis patients during their dialysis sessions to help treat malnutrition and protein-energy wasting) bag from the Intravenous (IV) pump machine (dirty task) at S4 with her gloved hands. Afterward, she removed her gloves but did not perform hand hygiene. Shortly after, she put on a new pair of gloves and continued her tasks, without perforning hand hygiene between glove changes. - At 11:13 a.m., RN CC was again observed taking a jug of Citric Acid (a solution that disinfects dialysis equipment, often in conjunction with heat to clean dialyzer membranes and machine fluid pathways) from S3 and placed it under the dirty sink next to the nurse’s station (dirty task) while wearing gloves. Then, she removed her gloves, immediately put on a new pair of gloves, and took another jug of citric acid from S4 to S5 (dirty task) without performing hand hygiene between glove changes. During an interview with RN CC on 8/26/25, at 2:40 p.m., she stated that she was doing her best to practice good infection control techniques. However, she acknowledged that she needed to improve on her hand hygiene practices, especially between glove changes. According to CDC recommendations, 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 ... 2. During observation in the Patient Treatment Room on 8/27/25 from 6:45 a.m. to 9:10 a.m., the following was revealed: - At 6:46 a.m., PCT CC was observed removing her contaminated gloves. Without performing hand hygiene, she then immediately began typing at the terminal computer (clean task) located between S3 and S4. Then she put on a new pair of gloves without performing hand hygiene beforehand and went to S11 to respond to a dialysis machine alarm (dirty task). At 8:54 a.m., she was again seen removing her gloves at S5. She then walked to S4 and failed to practice hand hygiene before putting on a new pair of gloves. - Patients at S10 and S11 were observed holding their access sites (dirty) with one gloved hand (after their hemodialysis treatment), until hemostasis (stopping of bleeding) was achieved. After glove removal, these same patients did not perform hand hygiene and were not offered a hand sanitizer by the Direct Patient Care (DPC) staff (nurses and PCTs). These same patients then proceeded to the weighing scale and exited the Patient Treatment Room where they touched the door handle (clean) without performing hand hygiene. These patients were not reminded by RN AA, PCT CC, or PCT DD to wash or sanitize their hands before leaving the Patient Treatment Room. Additionally, the surface of the door handle was not disinfected after being touched by the patients mentioned above which had the potential for cross contamination. A review of facility Policy: 1-05-01, titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: HAND HYGIENE: 1. All Teammates, Physicians, Non-Physician (NPP) will perform hand hygiene: b. prior to gloving and immediately after removal of gloves g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. 2. Patients and caregivers will be encouraged to b. Perform hand hygiene after treatment before leaving the treatment area. During a telephonic interview with PCT CC on 8/27/25, at 5:05 p.m., she stated she will make sure to do better with hand hygiene practice between glove changes and acknowledged this surveyor’s observation mentioned above. During an interview with PCT DD on 8/28/25, at 7:00 a.m., she stated that she typically instructs patients to sanitize their hands after treatment, particularly after applying pressure to their access sites. She acknowledged this surveyor’s observation mentioned above and recognized the importance of consistently performing hand hygiene, specifically immediately after removing gloves.”

“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: 52051 Based on observation, staff interview, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of the facility’s Policies and Procedures (P & P), it was determined that the facility failed to ensure that three of three Direct Patient Care Staff (Registered Nurse- RN CC, and Patient Care Technicians - PCT AA, and PCT BB), who were present during this observation, immediately and thoroughly cleaned and disinfected blood-contaminated surfaces on the cover of three of three sharps containers, between patient use. This failure could lead to the transmission of dangerous pathogens through cross contamination. This deficient practice had the potential to negatively affect the health and safety of all 43 in-center hemodialysis patients who were under the care of this facility. Findings include: On 8/26/25, at 11:06 a.m., dried drops of blood were observed on two of two sharps containers, located between Stations (S)5 and S6, and by the dirty sink next to the nurse’s station. - Each container had between two to four dried blood drops. These sharps containers had not been cleaned or disinfected between patient uses. - This observation was made after a complete changeover to the second shift when all six patients at stations (S1, S2, S5, S6, S7, and S8) were undergoing their hemodialysis treatments. - During an interview with PCT BB on 8/26/25, at 11:08 a.m., he stated that staff members usually clean the sharps containers after each patient’s treatment. He acknowledged the dried blood drops that this surveyor pointed out. - The Charge Nurse (RN CC) was notified of this observation, and she acknowledged the observation on 8/26/25 at 11:25 a.m. According to CDC guidelines, failure in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floors, patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces, etc., especially with blood splatters) must be performed between patient uses to prevent transmission of dangerous pathogens. A review of facility Policy: 1-05-01, titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials ...”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 52051 Based on a review of facility records, staff interviews, a review of facility Policy and Procedures (P & P), and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the Infection Control Committee failed to implement facility P & P for the prevention and control of infections as evidenced by failure to ensure that 18 of 18 Patients(P) (P#3, 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, P#21 and P#22), who were susceptible to the Hepatitis B virus (HBV), were offered Hepatitis B vaccination against Hepatitis B infection (a highly infectious disease of the liver caused by the HBV, and transmitted from person to person through blood and other body fluids). This failure could lead to the transmission of dangerous bloodborne pathogens through cross contamination and had the potential to negatively affect the health and safety of (P#3, 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, P#21 and P#22). The facility’s patient census was 43. Findings include: A positive Hepatitis B surface Antibody (HBsAb or anti-HBs) test result (10 or greater) indicates that a person has developed immunity to the HBV, either through successful recovery from past infection or through vaccination. HBsAb less than 10 means the person is susceptible. A review of the facility’s “Vaccination and Surveillance Report”, revealed the following: - P#3 was tested for HBsAb on 7/16/25, with a 3 mIU/mL (milli-international units per milliliter) result. - P#6 was tested for HBsAb on 7/16/25 with a 3 mIU/mL result. - P#7 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#8 was tested for HBsAb on 11/13/24 with a 5 mIU/mL result. This result had not been updated since. - P#9 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#10 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#11 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#12 was tested for HBsAb on 7/16/25 with a 3 mIU/mL result. - P#13 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#14 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#15 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#16 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#17 was tested for HBsAb on 7/16/25 with a 7 mIU/mL result. - P#18 was tested for HBsAb on 7/17/25 with a <3 mIU/mL result. - P#19 was tested for HBsAb on 7/17/25 with a 6 mIU/mL result. - P#20 was tested for HBsAb on 8/19/25 with a 4 mIU/mL result. - P#21 was tested for HBsAb on 7/16/25 with a <3 mIU/mL result. - P#22 was tested for HBsAb on 7/17/25 with a <3 mIU/mL result. There was no documentary evidence that P#3, 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, P#21 and P#22 were offered nor received the Hepatitis B vaccine and there was no documentary evidence that all 18 patients declined the Hepatitis B vaccination. During an interview with the Facility Administrator on 8/28/25, at 8:46 a.m., he rechecked the records and confirmed that those 18 patients mentioned above were neither offered nor received the Hepatitis B Vaccine, and there was no documented evidence to show that all 18 HBV susceptible patients refused the Hepatitis B vaccination. A review of Policy: 1-05-02, titled, “Hepatitis B SURVEILLANCE, VACCINATION, INFECTION CONTROL MEASURES AND ISOLATION GUIDANCE”, last revised April 2024, stated: 6. Documentation of the following will remain in the patient’s current active medical record: b. If a patient has received the hepatitis B vaccination series, a copy of the vaccination record. 13. Test all vaccinated patients for HBsAb one (1) to two (2) months after the last dose of full vaccine series (adequate response is defined as greater than or equal (>) 10 mIU/mL. a. If hepatitis B surface antibody (HBsAb) is less than (<) 10 mIU/mL, consider the patient susceptible, revaccinate with additional full series, and retest for HBsAb one (1) to two (2) months after the last dose of the second series. A review of the CDC recommendations stated that Hepatitis B vaccination is crucial for protecting hemodialysis patients, who have a higher risk of infection due to their underlying kidney disease and frequent exposure to blood and body fluids in the dialysis setting. During an interview with the Medical Director on 8/28/25, at 9:25 a.m., he stated that staff members, particularly nurses, typically offer vaccinations to patients who are susceptible to Hepatitis B. He also acknowledged this surveyor’s findings mentioned above.”

“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: 52051 Based on observation, staff interview, and a review of the facility’s Governing Body (GB) Bylaws, it was determined that the facility failed to ensure that the building in which dialysis services were provided was sanitary and maintained to ensure the safety of all patients and staff. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Patient Treatment Room, one of one Supply Room, and one of one Dialysate Preparation Room. The facility had 43 in-center hemodialysis (ICHD) patients. Findings include: During a facility tour with two Facility Administrators (Staff CC and Staff DD) from other clinics, who were filling in for the Facility Administrator (RN AA), on 8/26/25, between 9:50 a.m. to 11:15 a.m., the following was revealed: In the Patient Treatment Room: - The drain trap made of white polyvinyl chloride (PVC - a synthetic thermoplastic polymer material) in one of three clean sinks was broken, exposing the sink’s metal strainer sleeve and tailpiece. In the Supply Room: - The floor beneath the four-level shelving unit (located on the left side close to the entrance), was covered in a thick layer of dirt that was a dark brownish color, and there was a noticeable accumulation of dirt and dust on the floor, throughout the Supply Room. In the Dialysate Preparation Room: - There were four ceiling tiles with brown colored stains in different shapes, indicating signs of water damage. - The floor drain located beneath the Mixing Valve and another drain approximately three feet away in front of the Central Water Purification (CWP- a system to purify water for dialysis) system were partially covered with a brownish to rust-colored substance. - The floor under the work sink had a small puddle of standing water. The wet area measured approximately 1.5 feet (ft.) in length and 1 ft. in width. This surveyor presented all these findings mentioned above to Staff CC and Staff DD, who were also present at the time of the observation. Both acknowledged this surveyor’s observation on 8/26/25, at 10:20 a.m. During an interview with the Biomedical Technician (BMT) on 8/26/25, at 12:36 p.m., he stated that the brown stains on the ceiling tiles were caused by persistent heavy rain in the past, although he could not recall when it specifically started. He also acknowledged all other observations pointed out by this surveyor. A review of the facility’s GB Bylaws, confirmed and adopted by GB on October 4, 2019, stated: ARTICLE III: Management 3.6. Physical Environment The Governing Body shall: a. Ensure that the physical environment which ESRD facilities provide services is functional, sanitary, safe, and comfortable for patients and staff.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 52051 Based on a review of medical records, staff interviews, and review of facility Policy and Procedures (P & P), it was determined that the Medical Director failed to ensure that two of two patients (Ps), (P#2 and P#5) sampled, who experienced elevated blood pressure (BP) readings, received medical care/interventions appropriate to P#2’s and P#5’s 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. This deficient practice posed a risk to negatively impact the health and safety of P#2 and P#5. The facility census was 43. Findings include: 1. A review of P#2’s “Treatment Sheet” from 8/11/25 to 8/22/25, revealed the following: On 8/11/25, P#2’s pre-treatment BP was 213/86 mmHg and pre-treatment assessment was performed by Registered Nurse (RN CC). - At 3:40 p.m., P#2’s Hemodialysis (HD) treatment was initiated by RN CC, with a BP reading of 232/105 mmHg. - At 4:04 p.m., BP was 207/95 mmHg. - At 6:58 p.m., treatment was terminated, and BP was 144/79 mmHg. Discharge to home (routine discharge). Signed by RN CC. Throughout P#2’s hemodialysis (HD) treatment, there was no documented evidence that RN CC performed any nursing interventions regarding P#2’s high BP readings. Additionally, there was no documentation of re-assessment or further evaluation, nor any record of physician notification. Furthermore, there was no documentary evidence of a doctor’s standing order for P#2’s high BP readings during HD treatment. On 8/22/25, P#2’s BP readings ranged from 146/49 to 215/79 mmHg. - There was no documentary evidence that Patient Care Technician (PCT EE) and Licensed Practical Nurse (LPN AA) notified RN BB of P#2’s high BP readings. There was no documentary evidence that the nephrologist was notified by RN BB of P#2’s high BP readings. Throughout P#2’s HD treatment, there was no documentation indicating whether any assessment or intervention was provided by RN BB to address P#2’s elevated BP readings. 2. A review of P#5’s “Treatment Sheet” from 8/11/25 to 8/22/25, revealed the following: On 8/13/25, P#5’s pre-treatment BP was 182/83 mmHg and pre-treatment assessment was performed by RN BB. - At 8:51 a.m., treatment was initiated by PCT FF, with a BP reading of 182/83 mmHg. - At 10:01 a.m., BP was 207/88 mmHg. - At 10:30 a.m., BP was 182/82 mmHg. - At 11:31 a.m., BP was 196/86 mmHg. - At 12:00 p.m., BP was 201/85 mmHg. - At 1:00 p.m., treatment was ended by PCT FF, with BP reading of 177/75 mmHg. - P#5’s sitting BP post-treatment was 195/75 mmHg. During P#5’s HD Treatment, there was no documented evidence that PCT CC and PCT FF informed the RN about the high BP readings. Additionally, RN BB did not re-assess or re-evaluate P#5 regarding the elevated BP. Furthermore, RN BB failed to administer Clonidine 0.1 milligrams (mg) (medication to lower high blood pressure) orally every 4 hours PRN (as necessary) per the nephrologist’s standing order. During a telephonic interview on 8/27/25, at 5:05 p.m., PCT CC was asked how high BP readings were managed. PCT CC explained that she typically retakes BP to verify readings. If the readings remained high, she then notifies the nurse. She acknowledged this surveyor’s findings mentioned above and admitted that she sometimes forgot to document the interventions taken. In a separate interview with RN CC on 8/27/25, at 5:18 p.m., she stated that if a systolic BP reading is greater than 170, she usually notifies the doctor, although this can depend on which doctor was on duty. RN CC also emphasized that all PCTs must inform the RN of any high BP readings and RN CC added that she recognized the importance of complete and accurate documentation. PCT EE and PCT FF were not available for an interview. A review of Policy: 1-03-08, titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, last revised April 2024, stated: PRE-TRETAMENT DATA COLLECTION/ASSESSMENT 4. Abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section in this policy) ... The licensed nurse will assess the patient prior to the initiation of dialysis. 5. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. INTRADIALYTIC DATA COLLECTION/ASSESSMENT 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 13. All findings, interventions and patient response will be documented in the patient’s medical records. ABNORMAL FINDINGS Blood Pressure: Pre-dialysis and Intradialytic *Systolic greater than 180mmHg or less than 90mmHg *Diastolic greater than or equal to 100 mmHg or less than 50 mmHg Post Treatment - If the patient can stand: *Standing systolic BP greater than 140 mmHg or less than 90 mmHg *Standing diastolic BP greater than 90 mmHg or less than 50 mmHg - Sitting BP for patients that cannot stand: * Sitting systolic BP greater than 140 mmHg or less than 90 mmHg * Sitting diastolic BP greater than 90 mmHg or less than 50 mmHg A review of “Abnormal Findings Job Aid: ICHD” (in-center hemodialysis), with no date, stated: Purpose: ... An assessment by the nurse prior to initiation of dialysis, during dialysis, and/or prior to discharge will be triggered by an abnormal finding. The medical record should indicate the finding, the intervention, physician notification, physician orders, and the patient response. During an interview with the Medical Director on 8/28/25, at 9:25 a.m., he stated that in cases of high BP readings for patients, nurses typically administer treatment to patients and monitor whether the BP decreases. This surveyor also notified the Medical Director that PCTs did not notify the nurses, and there were no documented nursing interventions or evaluations on the treatment sheets reviewed. The Medical Director acknowledged this surveyor’s findings and recognized the importance of Direct Patient Care (DPC) staff adhering to the facility’s P & P regarding high BP readings.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 52051 Based on a review of Fiscal Year (FY) 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), a review of facility records, and staff interviews, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to track and trend, perform root cause analysis, develop and implement plans of action, evaluate its effectiveness and make changes to plans of action if necessary, to improve and sustain patient outcomes for the facility’s Hospitalization & Re-admission and Anemia outcomes specifically, management of patients with Hemoglobin (Hgb - Protein in red blood cells that carries oxygen throughout the body) less than (<) 10 grams per deciliter (g/dL) for in-center hemodialysis (ICHD) patients, in six of six months (February 2025 - July 2025) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 43 ICHD patients who were receiving dialysis services at this facility. Findings include: A comparison between the facility’s FY 2025 QDFR and the facility’s QAPI meeting minutes between (February 2025 - July 2025), revealed the following: 1. Hospitalization and Re-admission: - FY 2025 QDFR - none reported. - QAPI - percent of patients who were re-admitted to the hospital within 30 days, ranged from 15.38% - 34.62%. The US threshold was 1.04%. 2. Hemoglobin <10 g/dL: - FY 2025 QDFR - 36.1% of ICHD patients had Hemoglobin <10 g/dL. - QAPI - percent of patients with Hemoglobin <10 g/dL ranged from 22% - 33% (with the last three months trending higher). The US threshold was 23%. There was a lack of documentary evidence that the entire Interdisciplinary Team (IDT) was fully involved in tracking and trending hospitalizations/re-admissions and hemoglobin levels. Additionally, there was also a lack of documentary evidence that the IDT performed root cause analysis, developed and implemented action plans, evaluated their effectiveness, or modified plans to improve and sustain patient outcomes. During an interview with the Nurse Manager, RN BB, on 8/27/25, at 3:16 p.m., she stated that she was primarily responsible for tracking clinical outcomes, including patients’ Hemoglobin levels. She also mentioned that she developed action plans based on the results of these outcomes. During a discussion with the Facility Administrator (RN AA), Assistant Facility Administrator (Staff BB), and RN BB on 8/28/25, at 3:28 p.m., RN AA stated that the same interventions for Anemia Management were carried out from February 2025 to June 2025. He acknowledged that these interventions should have been revised and adjusted. Additionally, he confirmed that a root cause analysis for hospitalizations and re-admissions should have been conducted thoroughly. Furthermore, he emphasized that plans for correction should not only be developed but also properly implemented, evaluated, and updated or revised if they were not effective in improving and sustaining outcomes.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 52051 Based on a review of facility records and staff interview, it was determined that the Medical Director failed to ensure that one of one Registered Nurse (RN CC) sampled, received and completed the Annual Competency Training in a timely manner. It is essential for staff involved in patient care to receive the appropriate education and training to competently perform their job responsibilities. This failure had the potential to negatively affect the health and safety of 43 in-center hemodialysis patients who were under the care of this facility. Findings include: During a review of the Personnel File of RN CC, she was hired on 8/8/22. According to her Personnel Record, RN CC completed her Water and Dialysate, and Dialysis Machine training on 6/30/25 and Emergency Preparedness Training on 8/2/25. However, there was a lack of documentary evidence that RN CC had completed her Annual Competency Training as a Chronic Dialysis RN over the past 12 months; topics covering like Complications of Dialysis, Medication Management, Quality Improvement Initiatives, Patient Care Management, etc. During an interview with the Assistant Facility Administrator (Staff AA) on 8/28/25, at 8:16 a.m., she stated that RN CC had completed the Annual Competency Training for this year, just like the other staff members. She also mentioned that she would attempt to retrieve the training documentation electronically and submit it as soon as possible. On 8/28/25, at 11:00 a.m., this surveyor followed up with Staff AA regarding RN CC’s Annual Competency Training. Staff AA stated that she could not find it on their system. - Staff AA was not able to provide a documentary evidence of RN CC’s RN Annual Competency Skills Checks at the time of the exit interview on 8/28/25, at 12:10 p.m.”

“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: 52051 1. Based on observation, staff interview, and a review of the facility’s Policy and Procedures (P & P), it was determined that the facility failed to ensure that one of one Registered Nurse (RN CC), who prepared Heparin (anticoagulant used in hemodialysis to prevent clotting in the bloodlines and dialyzer/artificial kidney) and Venofer (used to treat iron deficiency among dialysis patients) injections, and oral medications, for second shift patients, labeled two of two Heparin syringes, two of two Venofer syringes, and three of three oral medications in plastic medication cups, with date and time prepared, and her initials. This deficient practice increased the risk for medication errors. The facility had 43 in-center hemodialysis (ICHD) patients. Findings include: During a tour in the Patient Treatment Room on 8/26/25 between 9:35 and 9:42 a.m., the following was observed: In the Medication Preparation Area: - There was one 10 mL (milliLiters) syringe containing Heparin injection for hourly infusion, and one 5 mL syringe of Heparin injection for bolus infusion, three 10 mL syringes of Venofer injections, and three plastic medication cups with oral medications in them that were prepared and labeled with the patients’ names, but they lacked the staff’s initials and the date and time of preparation. During an interview with RN CC on 8/26/25, at 11:02 a.m., she confirmed that she prepared all the Heparin and Venofer injections, and pills in the plastic medication cups for second shift patients. She mentioned that these medications were prepared at 9:00 a.m., on this date (8/26/25). RN CC also stated, “I usually label them.” She acknowledged that it was important to label prepared medications with her initials, time, and date, and not just the patients’ names. A review of facility Policy #1-06-01 titled, “Medication Policy”, dated October 2023, stated: 20. If medications are prepared and administered immediately by the same licensed nurse teammate, they do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient’s name, date, time prepared, dose, and initials of the teammate preparing the medication. During a discussion with the Medical Director on 8/28/25, at 9:25 a.m., he stated that it was important for the staff members to adhere to facility’s P & P. He also acknowledged this surveyor’s observations mentioned above. 2.Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) Guidelines, a review of Food and Drug Administration (FDA) Guidelines, a review of the manufacturer’s Direction for Use (DFU), and a review of facility Policies and Procedures (P & P), it was determined that the facility failed to ensure that one of one Registered Nurse (RN CC), who was responsible for administering medications, properly labeled one of one opened and accessed vial of Tuberculin Purified Protein Derivative (PPD Mantoux - a diagnostic antigen to aid in the detection of infection with Mycobacterium Tuberculosis) in one of one medication refrigerator, in order to track shelf life after it was opened and for preventing the administration of expired products. This failure had the potential to negatively affect the health and safety of 43 in-center hemodialysis patients who were under the care of this facility. Findings include: During a facility tour with two Facility Administrators (Staff CC and Staff DD) from other clinics, who were filling in for the Facility Administrator (RN AA), on 8/26/25, between 9:50 a.m. to 11:15 a.m., the following was revealed: In the Medication Refrigerator: - There was an opened and accessed vial of Tuberculin PPD Mantoux, which did not have a time and date indicating when it was opened. During an interview with Staff CC on 8/26/25, at 9:58 a.m., who was present at the time of the observation, confirmed that the Tuberculin PPD Mantoux vial (mentioned above) was not labeled with the staff initials and the date vial was opened. Staff DD who was also present at the time of the observation, acknowledged this surveyor’s observation on 8/26/25, at 10:00 a.m. During an interview with RN CC on 8/26/25, at 2:40 p.m., she stated that she was not aware that the opened and accessed PPD vial was not labeled with staff initials and date it was opened. She stated that she was responsible for all medication preparations and administration. RN CC also recognized the importance of labeling opened vials with the date they were opened, along with her initials. According to CDC Guidelines, multi-dose vials typically contain an antimicrobial preservative to help prevent the growth of bacteria. If a multi-dose vial has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. A review of FDA guidelines stated: - A vial of Tuberculin PPD (Mantoux) Tubersol, which has been entered and in use for 30 days should be discarded. A review of the Manufacturer’s DFU stated: - A vial of Tuberculin PPD solutions which has been entered and in use for 30 days should be discarded. A review of the facility’s Policy: 1-06-01, titled, “Medication Policy”, with the latest revision date of October 2023, stated: 29. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date ... Each vial is labeled with the initials of the person opening the vial and the expiration date ... During a discussion with the Medical Director on 8/28/25, at 9:25 a.m., he stated that it was important for the staff members to adhere to facility’s P & P.”