Davita Laurens County Dialysis

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observations, a review of records, staff interviews,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 67 patients who dialyzed at this facility. Findings include: Cross References: V 757 - Failure of the Facility Administrator to ensure the facility had 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. V765 - Failure of the Governing Body to ensure that all Direct Patient Care Staff (nurses and patient care technicians, who will be referred to as Employee #1, Employee #2, Employee #3, Employee #4, Employee #5, and Employee #6, for anonymity), adhered to facility P&P relative to patient complaints and grievances.”

“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: 49321 Based on observation, staff interview, a review of Centers for Disease Control and Prevention (CDC) recommendations, and a review of the facility’s Policies and Procedures (P&P), it was determined that the Infection Control Committee failed to ensure that two of two Registered Nurses (RN AA and RN BB) observed, and four of four Patient Care Technicians (PCT AA, PCT BB, PCT CC, and PCT DD ), who were present during this observation, promptly and thoroughly cleaned and disinfected blood-contaminated surfaces and dialysis equipment when first observed and after patients completed their hemodialysis treatments. This deficient practice increased the risk for cross-contamination and transmission of dangerous pathogens, that could negatively affect the health and safety of 13 of 13 patients (P) #7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, and P#19), who were undergoing hemodialysis treatment at the time of this observation. The facility census was 67 in-center hemodialysis patients. Findings include: During observation in the Patient Treatment Room on 8/26/25 from 11:00 a.m. to 1: 00 p.m., the following was revealed: Sharps Containers: - The top plastic lids of the Sharps Containers at Station (S) 4, S9, S12, S19, S20 and at the Isolation Room, had two to six dried drops of blood in various sizes from a pinhead size to approximately 0.5 to 1.0 centimeter (cm) in diameter. - During an interview with the Charge Nurse/Registered Nurse (RN AA) on 8/26/25 at 11:15 a.m., RN AA stated that Sharps Containers were to be wiped down at the end of each day. - According to CDC guidelines, failure in environmental cleaning and disinfection have led to the 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 Policy #1-05-01, titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES”, last revised 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 (i. e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. iii Cleaning of visible blood should be performed when first observed.”

“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: 49321 Based on observation, staff interview, a review of the Centers for Disease Control and Prevention (CDC) guidelines and recommendations, and a review of facility Policies and Procedures (P&P), it was determined that the Infection Control Committee failed to ensure that one of one Registered Nurse (RN) AA observed during initiation of hemodialysis (HD) treatment on two of two patients (Ps) (P#7 and P#8), who had Central Venous Catheters (CVC- a thin flexible tube that is placed into a large vein above the heart), as their primary dialysis access, utilized appropriate infection control techniques to prevent cross contamination. This breach in infection control techniques had the potential to cause central line associated bloodstream infections (when germs enter a patient’s bloodstream through the central line). This deficient practice could negatively affect the health and safety of P#7 and P#8, and the other 19 patients who had a CVC, as their primary dialysis access. The facility census was 67. Findings include: During observation in the Patient Treatment Room on 8/26/25 from 11:00 a.m. to 1:00 p.m., the following was revealed: - RN AA was observed at Station (S) 19 wearing a face shield. During catheter manipulation (which included removal of the old dressing, cleaning of the catheter hubs, and connection of the dialysis blood lines), RN AA was not wearing a mask to cover her mouth and nose. - During an interview at 11:05 a.m. on 8/26/25, RN AA was asked whether a mask should be worn when accessing a catheter. RN AA responded by stating that the face shield was the mask. - RN AA repeated this breach in infection control techniques during initiation of hemodialysis to P#8 (who had a CVC) at S20. RN AA did not wear a mask while performing the same procedure as mentioned above. - According to CDC guidelines and recommendations, which is also supported by NKF/KDOQI’s (National Kidney Foundation’s Dialysis Outcomes Quality Initiative’s) expert guidance, both healthcare personnel and patients should wear surgical masks during any catheter manipulation, including access, connection, and disconnection. Evidence demonstrates significant reductions in catheter-related bloodstream infections when masking is universally adopted.” A review of Policy # 1 -04-02B, titiled, “CENTRAL VENOUS CATHETER (CVC) WITH CLEARGUARD HD ANTIMICROBIAL END CAPS PROCEDURE”, last revised April 2025, stated: - Use dialysis precautions and aseptic technique throughout the procedure. - Teammate and patient will wear a mask covering the nose and mouth during this procedure (accessing a central venious catherter). -These measures are vitial to preventing the exposure of the catherer and exit site to nasal droplets and infectious bacteria such as methicillin-resistant Staphylococcus Aureus (MRSA). The Facility Administrator was notified of the above findings on 8/26/25 at 2:00 p.m.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 49321 Based on observation, staff interview, a review of facility Policy & Procedures (P&P) and a review of the Governing Body Bylaws, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was clean, sanitary, orderly and maintained free from trash to ensure safety of all patients and staff. These environmental concerns were observed in one of one Supply Room, in one of one Dialysate Preparation Room, in one of one Patient Treatment Room and in one of one Biohazard Waste Storage Area. The facility census was 67. Findings include: During a tour of the facility with the Facility Administrator on 8/26/25 between 10:00 a.m. and 11:00 a.m., the following was observed: In the Supply Room: - Two (four-tier) shelving units had a visible brown, sticky substance on their surfaces. Brand-new sleeves of 30 mL (milliLiter) medication cups were stored directly on top of this sticky substance on the shelves, as well as Chlorine and chloramine test strips, five cases of Nipro SafeTouch needles, approximately 25 to 50 individually wrapped 14-gauge needles, and two cases of Med Source boxes containing vacutainer tubing and other lab supplies, were stored on top of the shelving units with the sticky substance. - Dirt, paper, and lint particles were present under all shelving units. The floor throughout the supply room was visibly dirty. - Dead insects (spiders and small roaches) were present in multiple areas, including the corners near the large garage door, under crates of Bibags (a single-use, single-bag disposable containing dry, USP - grade sodium bicarbonate powder) and dialyzers, and near the electrical box. - Next to the Acid Holding Tank, located in the Supply Room, there were three large boxes that were stacked up high almost touching the ceiling (approximately less than an inch from the ceiling), which had the potential risk of falling to the floor. - Next to the above-mentioned boxes were two (four-tier) shelving units that appeared unstable because the center of the shelving was buckling under the weight of 25 containers of (one gallon of bleach each container), four large bags of an unidentified powdered substance, one gallon of floor cleaning solution, two quarts of PVC primer, and three medium-sized boxes filled with miscellaneous items. On one of the top shelves, a stove hood was kept that was facing toward the ceiling. Directly beneath the hood were two large boxes of long white paper rolls. The same shelving unit also held an old box of miscellaneous items, bottles of Myron L meter calibration solution, and several dialysis machine parts stored in worn, weakened boxes. A medium-sized ladder was leaning unsecured against the shelving unit. - Crammed in the corner next to the above-mentioned shelves was a 10-gallon container of white paint that had several boxes stacked up on top of it. - High up in the right-hand corner of the Supply Room, near the Acid Holding Tank, was a visible dark brown, crystallized substance on the wall. It appeared to have leaked from the ceiling and ran down the wall to the floor. At floor level, pallets of dialyzers, cases of dry acid, and bicarbonate bags were stored in close proximity to the crystallized substance on the wall. - On 8/28/25 at approximately 9:00 a.m., when this surveyor showed the above-mentioned visible dark brown, crystallized substance on the wall, the Biomedical Technician (BMT) stated that one of the Patient Care Technicians (PCTs) transferred the Acid solution through the wrong loop and it leaked out of the ceiling down to the floor and it had not been cleaned since (approximately several months ago). The BMT further stated that they fixed the loop but did not clean up the leaked substance. In the Dialysate Preparation Room: - The whole floor was covered in a white, flaky substance. - The “Acid Mixing” sign on the large Acid Mixer Tank, had a moderate amount of black, fuzzy substance. - The pump on top of the large Acid Mixer Tank, was coated with thick layers of white, flaky residue, and the steel base beneath the pump was covered with a rust-colored substance. The interior of the clear tubing used to transfer mixed acid to the Acid Holding Tank was coated with a dark brown substance, and the silver hose clamp on the tubing was covered with a fuzzy, blackish-brown residue. - Two large rolling carts were covered with a very thick white substance. - In the middle of the Eye Wash Station bowl, was a thick layer of a rust-colored substance. - The large drain to the left of the Acid Mixing Tank (used to store many bags of salt pellets) had rust-colored buildup in each corner, along with thick layers of a white, crystalized substance. - The drain next to the Booster Pump had a large area of rust-colored substance surrounding it. The Patient Treatment Room: - The front and right side of the Emergency Crash Cart, (a portable, wheeled unit containing life-saving medications, equipment, and supplies for immediate use in critical medical emergencies, such as cardiac arrest, that may occur during dialysis treatment), had splatters of dark brown, sticky substance. - The two privacy screens located next to the Emergency Crash Cart, also had the same dark brown, sticky substance splattered on them. - The same dark brown sticky substance was splattered on the white plastic drain pipe cover under the clean sink, located to the left of the Emergency Crash Cart. - The seat of the hemodialysis chair located inside the Isolation Room had five large tears in the leather upholstery. Biohazard Waste Storage Area : - The room was littered with empty cardboard boxes, large white pieces of paper and used blue gloves turned inside out. There were small dead spiders and small roaches in the corners in this room. The Exam Room : The exam room sink has a dried white and green substance in it. A review of Policy. 1-05-01, titled . “INFECTION CONTROL FOR DIALYSIS FACILITIES”. revised April 2023, stated: Page 2 SUPPLIES 8. Supplies will be stored in a manner that maintain their integrity. b. Expiration date and package integrity will be verified prior to use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used. A review of the “Governing Body Bylaws”, showed the following: 3.6 Physical Environment a. Ensure that the physical environment in which ESRD facilities provide services is functional, sanitary, safe, and comfortable for patients and staff. The Facility Administrator acknowledged the above findings on 8/26/25 during the tour (between 10:00 a.m. and 11:00 a.m.).”

“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 interview, a review of facility Policy & Procedures (P&P) and a review of the Governing Body Bylaws, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was maintained and free from damage and defects to ensure the safety of the 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 Supply Room, in one of one Dialysate Preparation Room, in one of one Patient Treatment Room and in one of one Biohazard Waste Storage Area. The facility census was 67. Findings include: During a tour of the facility with the Facility Administrator on 8/26/25 between 10:00 a.m. and 11:00 a.m., the following was observed: In the Supply Room: - The floor had deep cracks filled with white, brown, and black debris. - When entering the supply room, on the left-hand side, there was a 5-inch-wide floor drain with the cover missing. The surrounding epoxy flooring was heavily soiled with thick dirt particles, and the concrete near the drain was chipped and cracked, exposing the first layer of concrete beneath the surface. In the Dialysate Preparation Room: - The whole floor was covered in a white, flaky substance. The Patient Treatment Room: - The leather upholstery on the seat of the hemodialysis chair located inside the Isolation Room had five large torn areas. Biohazard Waste Storage Area: - The floor had a long thick crack leading from the entrance door to the exit door in this room. A review of Policy. 1-05-01, titled . “INFECTION CONTROL FOR DIALYSIS FACILITIES”, revised April 2023, stated: Page 2 SUPPLIES 8. Supplies will be stored in a manner that maintain their integrity. b. Expiration date and package integrity will be verified prior to use. d. Anytime the integrity of a package with or without an expiration date is in question, i.e., torn, ripped, wet or contaminated, the package and its contents must be disposed of and not used. A review of the “Governing Body Bylaws”, showed the following: 3.6 Physical Environment a. Ensure that the physical environment in which ESRD facilities provide services is functional, sanitary, safe, and comfortable for patients and staff. The Facility Administator acknowledged the above findings on 8/26/25 during the tour (between 10:00 a.m. and 11:00 a.m.).”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 49321 Based on record review, staff interview, and a review of the facility Policy and Procedures (P&P), it was determined that the facility failed to ensure that the Interdisciplinary Team (IDT) developed an annual individualized Plan of Care (POC) on three of six patients (Ps) (P#3, P#4, and P#5), sampled. Failure to develop an annual POC may result in a lack of achieved patient’s clinical outcomes and goals, such as improved lab values, managed symptoms, identifying new patient concerns, and improved ways to enhance quality of life. This deficient practice had the potential to negatively affect the health and safety of P#3, P#4, and P#5. The facility had 67 in-center hemodialysis (ICHD) patients. Findings include: A review of the medical records revealed the following: - P#3 was admitted to this facility on 7/14/23. The latest Annual Care Plan was dated 5/14/24. - P#4 was admitted to this facility on 7/14/17. The latest Annual Care Plan was dated 7/29/24 - P#5 was admitted to this facility on 05/19/21. The latest Annual Care Plan was dated 5/20/24 . The Facility Administrator stated on 8/28/25 at 11:00 a.m., that she was unable to locate any additional documented evidence of current, individualized annual POCs for the patients mentioned above. - A review of the facility’s policy and procedure # 1-14-01, titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care”, stated: 7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: - At least annually for stable patients”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 49321 Based on medical record review, staff interview and a review of facility Policies and Procedures ( & P), it was determined that the facility failed to ensure that two of six sampled patients (Ps) (P#1 and P#4), had a Patient Care Plan that reflected participation of all members of the Interdisciplinary Team (IDT), including the patient or patient representative. This lack of IDT collaboration and participation had the potential failure to identify new patients’ concerns and outcomes that were not achieved. The facility census was 67. Findings include: A review of the medical records revealed the following: - P#1 was admitted to this facility 4/17/21 and had an Annual Plan of Care completed on 7/31/25. - P#4 was admitted to this facility on 7/14/17. The latest Annual Care Plan was dated 7/29/24. Both patients’ (P#1’s and P#4’s) Care Plans did not have IDT signatures, nor any signatures from the patients or their representatives, as required per facility P&P to reflect participation in the development or discussion of their Annual Care Plans. - The Facility Administrator acknowledged the above findings on 8/28/25 at 11:00 a.m. - A review of Policy: 1-14-01 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” dated October 2024, showed the following: - The patient’s plan of care will be completed by facility’s interdisciplinary team, including patient or personal representative and be signed by team members including the patient or the patient’s personal representative. If the patient chooses not to sign the plan of care, this choice will be documented on the plan of care, along with the reason the signature was not provided.”

“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: 49321 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) recommendations and guidelines, and a review of facility Policies and Procedures (P&P), it was determined that the Medical Director failed to ensure that four of four Licensed Nurses (Registered Nurses - RN AA, RN BB, RN CC), and Licensed Practical Nurse - LPN AA), who were responsible for administering medications, adhered to the facility’s medication policy. This deficient practice increased the risk for medication errors. The facility had 67 in-center hemodialysis patients. Findings include: During observation in the Patient Treatment Room on 8/26/25 between 11:00 a.m. and 1:00 p.m., the following was revealed: In the Medication Preparation Area: - There were nine 5 ml [milliliters) syringes containing Venofer 50 mg (for the treatment of iron deficiency anemia), five 30ml medicine cups with Sensipar tablets (for the treatment of secondary hyperparathyroidism in dialysis patients by lowering parathyroid hormone levels, which in turn helps reduce high levels of calcium and phosphorus), four 10 ml syringes containing heparin (anticoagulant) for hourly infusion and five 10 ml syringes of heparin for bolus infusion that were prepared and labeled with the patients’ names, but lacked the nurse’s initials, and the date and time of preparation. - During an interview on 8/26/25 at 2:30 p.m., RN BB stated, we always label medications with patients’ names but never write the initials, date and time on our medication labels. - During an interview on 8/26/25 at 4:11 p.m., RN AA stated that she never thought to add the date, time, and initial the patients’ medication labels. According to CDC - Dialysis Safety Guidelines, all medication should be labeled (vials, syringes, and infusions) with the date and time of preparation when not used immediately. A review of the facility’s Policy: 1-06-01 titled, “Medication Policy” with the latest revision date of October 2023, showed the following: 17. Medication preparation should be performed only for the current shift of patients, i.e. do not prepare medications for more than one shift of patients. 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.”

“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: 49321 Based on a review of facility records, staff interviews, a review of facility Policy and Procedures (P & P), and a review of minimum state required staffing ratios, it was determined that the Facility Administrator 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, for every 12 patients receiving dialysis care and that each care giver was not assigned more than four patients at any given time. 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, medication errors, 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 in-center hemodialysis census was 67. Findings include: During a review of the facility’s Staff/Patient schedule between 8/13/25and 8/23/25, the following was revealed: The facility had 21 patient stations (S), including one Isolation Room, organized into five Pods/Sections (each Pod with four patient stations). Dialysis treatments were scheduled with two main rotations: Mondays-Wednesdays-Fridays (MWF), with three shifts per day and Tuesdays-Thursdays-Saturdays (TTS), with two shifts per day. On the MWF schedule: - First shift: 15 patients - Second shift : 16 patients - Third shift : 2 patients On the TTS schedule: - First shift : 16 patients - Second shift : 15 patients - On 8/13/25 , 8/15/25, 8/16/25, and 8/19/25, Registered Nurse (RN BB) was assigned as a dialysis caregiver to four patients during the first and second shifts at Pod #3, stations (S7, S8, S9 and S10), which included setting up of hemodialysis machines before patient treatment and patient disconnection, system takedown, surface cleaning and disinfection of each dialysis station after each patient treatment at her assigned Pod. RN BB also handled phone calls, performed pre and post assessments, and prepared and administered medications for patients at her assigned Pod#3. In addition, record review revealed that RN BB was also responsible for nursing duties to four other patients at Pod #2, stations (S3, S4, S5, and S6), including but not limited to: preparing and administering medications, performing pre and post treatment assessments, etcetera (etc.). - On the same above dates, there were three Patient Care Technicians (PCTs), PCT AA, PCT BB, and PCT CC, who were assigned as dialysis caregivers to four patients each. - RN AA was assigned as Charge Nurse (CN) on 8/13/25, 8/19/25 and 8/23/25 responsible for eight patients to administer nursing duties to. RN CC was assigned as CN on 8/15/25 and 8/16/25, and responsible to administer nursing duties to eight patients. - LPN AA was assigned as dialysis caregiver to four patients at Pod #3 per shift on 8/23/25, in addition to her nursing duties at Pod #2. - During an interview with RN AA on 8/26/25 at approximately 1:00 p.m., RN AA stated that she didn’t have an issue with the schedule. She was the CN and she confirmed that she was not assigned a Pod as dialysis caregiver per shift. - During an interview conducted on 8/26/25 at 2:30 p.m., RN BB stated that she had been employed at the facility for six months and had felt overwhelmed. She reported that she had consistently been assigned to a Pod of four patients as a dialysis caregiver and another four patients in another Pod to perform nursing duties, including preparation and administration of medications and pre- and post patient assessments. RN BB expressed that she had not felt safe in that environment, as the workload had caused her to feel rushed, which she believed could increase the risk of making mistakes. - During an interview with RN CC on 8/27/25 at approximately 12:00 p.m., she stated that she didn’t have an issue with the schedule. A review of Policy #8-02-01, titled, “Teammate Qualifications, Licensure and Adequate Teammate Staffing”, last revised October 2017, stated: POLICY: 4. 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 giving and meets the need of the patients.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 49321 Based on a review of facility records, patient and staff interviews, a review of the facility’s Policies and Procedures (P&P), and a review of the Governing Body Bylaws, it was determined that the facility failed to ensure that all Direct Patient Care Staff (nurses and patient care technicians, who will be referred to as Employee #1, Employee #2, Employee #3, Employee #4, Employee #5, and Employee #6, for anonymity), adhered to facility P&P relative to patient complaints and grievances. Failure to follow facility P & P regarding patients’ voiced concerns, complaints and grievances, deprived one of one Patient (P) #1, and potentially all the other 66 patients who were receiving dialysis services at this facility, a culture of safety to be able to freely voice their concerns, complaints and grievances and to be provided support and resolutions without fear of retaliation. Findings include: - On 8/26/25 at approximately 10:00 a.m., upon entering the facility, this surveyor was approached by P#1. P#1 stated that she had submitted two grievances during the month of July, 2025, but both written grievances had disappeared. P#1 expressed concern that no one had addressed or resolved the issues and she was afraid of the care given to her by one of the nurses at this facility. P#1 gave this surveyor a written copy of her complaint. During a review of the facility’s Complaint and Grievance Logs between March 2025 and August 2025, it was revealed that only one patient (P#2) filed a grievance in the month of July, dated 7/8/25, unrelated to P#1’s complaints. P#1’s complaints/grievance was not found in the July, 2025 complaint/grievance logs. There were no documented grievances for the month of August. On 08/26/25 at 1:00 p.m., the Facility Administrator was asked whether the complaints/grievance found in the July 2025 Complaints and Grievance Logs was the only grievance filed for that month, the Facility Administrator stated, that there was only one grievance (P#2’s grievance), that she was aware of. A review of P#1’s Treatment Details Reports dated 7/5/25 and 7/10/25 revealed the following: On 7/5/25: - At 7:32 a.m., P#1’s Blood pressure (BP) reading was recorded at 98/54 mmHg (millimeter of mercury). Employee #1 documented that P#1was alert and reported no complaints. - At 8:22 a.m.(50 minutes later), P#1’s BP reading was 91/49 mmHg. Employee #1 documented that the nurse (Employee #2) was notified of P#1’s low BP reading. - At 8:32 a.m., P#1’s BP reading further declined to 88/53 mmHg. Employee #3 documented that the ultrafiltration (UF- the process of removing excess fluid from the body during dialysis) was stopped due to hypotension. P#1 exhibited signs and symptoms consistent with low BP reading. The nurse (Employee #2) was made aware of the low BP reading by Employee #3 (patient care technician), but employee #2 did not respond. So Employee #3 placed P#1 in a Trendelenburg position (where patient was placed flat on her back and the feet were raised higher than their head), and Employee #3 administered 200 mL (milliLiter) of normal saline (NS) intravenously to P#1. Monitoring was continued. - At 8:40 a.m., BP reading improved to 127/59. Employee #3 documented that P#1 was stable and BP reading had stabilized. On 7/10/25: - At 7:32 a.m., P#1’s BP reading was recorded at 181/81 mmHg. Employee #4 documented that P#1 was tearful while sitting at her dialysis chair, speaking with the Facility Administrator. - At 8:02 a.m., P#1’s BP reading was 128/64 mmHg. Employee #3 documented that P#1 appeared to be tolerating treatment well at that time and was still speaking with the Facility Administrator. - During an interview on 8/26/25 at 1:52 p.m., Employee #1 stated that P#1’s BP reading was low during treatment on 7/5/25. Employee #1 stated that she approached the nurse (Employee #2) and Employee #1 requested Employee #2 to come assess P#1 on 7/5/25 due to low BP reading. Employee #1 also stated that after informing the nurse (Employee #2) about P#1’s low BP reading, Employee #1 then returned to P#1 and rechecked her BP reading; however, the nurse (Employee #2) remained seated at the Nurse’s Station and did not respond to Employee #1’s request to check on P#1. When asked why she did not administer fluids herself, Employee #1 explained that she was new to dialysis and was unsure of the appropriate interventions for a patient with a central venous catheter (CVC- a thin, flexible tube inserted into a large vein in the neck, chest or groin used as hemodialysis access). Specifically, she did not know whether she was permitted to administer fluids or perform a rinse-back for patients with CVC. Employee #1 further stated that the assigned Pod nurse (Employee #4) was on break at the time, and the covering nurse (Employee #2) was sitting at the desk and appeared to be unoccupied. She emphasized that this was why she had asked the nurse (Employee #2) to “please come see about P#1”. Ultimately, another staff member Employee #3 (patient care technician) intervened and assisted P#1. - During an interview on 8/26/25, at 2:05 p.m., Employee #3 stated that on 7/5/25, P#1 experienced low BP reading during treatment. In response, she reclined (placed on Trendelenburg position) P#1’s chair and administered normal saline to help stabilize P#1’s condition. Employee #3 reported that she approached the nurse (Employee #2) who was covering for Employee #4 (nurse) while on break. Employee #2 was sitting at the desk and not engaged in patient care, and was asked by Employee #3 why Employee #2 had not come to assess P#1 as requested and to help stabilize P#1. According to Employee #3, Employee #2 stated that she was busy. P#1 expressed fear to both Employee #3 and other staff members present that day, stating this was the second instance where the same nurse (Employee #2) failed to assist her during a critical moment. During an interview on 8/26/25 at 2:34p.m., Employee #4 stated that she had been on break during the initial incident involving P#1 on 7/5/25. Upon returning to the Patient Treatment Room, Employee #4 stated that she was informed by Employee #1 and Employee #3 about what had occurred. Employee #4 stated that P#1 verbalized her concerns to her, and in response, Employee #4 advised the Facility Administrator to speak directly with P#1 regarding her concerns. Employee #4 further stated that P#1 informed Employee #4 that P#1 placed her written grievance form inside the Administrative Assistant’s office window. P#1 further stated that she submitted two written grievance forms of the same issue on 7/5/25 (which went missing) and on 7/8/25, which also went missing. Employee #4 further stated that the day after the first grievance was filed, the Facility Administrator held a meeting with the clinical staff (which included PCTs, Nurses and Administrative Assistant) and informed them that patients were no longer to be given official grievance forms. Instead, staff were instructed to either write the grievance on behalf of the patient or provide the patient with a blank sheet of paper to write on. During an interview on 8/26/25 at 3:00 p.m., Employee #5 (nurse) stated that the first grievance form submitted by P#1 was later found by the Facility Administrator, in a large, locked container where documents for shredding was kept. Prior to discovering the form, the Facility Administrator held a staff meeting and informed all team members that patients were not to be given official grievance forms. Staff were instead instructed to either write the grievance on behalf of the patient or provide a blank piece of paper for the patient to use. Employee #5 further reported that P#1 later wrote a second grievance on a blank piece of paper. Another staff member (Employee #6 - nurse), stapled it to an official grievance form and placed it in the Social Worker’s office. That grievance sheet also went missing and was never addressed by the Facility Administrator. The Social Worker was on vacation at the time of this incident and then left the facility late July 2025. During a telephonic interview with P#1 on 08/26/25 at 6:00 p.m., P#1 stated that in October 2024, she was admitted to this facility. She reported that during one of her early treatments, she told the nurse (Employee #2) that her BP was dropping. The nurse reportedly responded with “okay” and walked away. Employee #7 (nurse, who was not currently working at this facility), administered fluids, but P#1 stated that she was later hospitalized as a result of low BP reading. P#1 added that on 7/5/25, during a dialysis session, P#1 began to feel unwell while her assigned nurse (Employee #4), went on break. She stated that her dialysis machine kept beeping. P#1 stated that Employee #3 asked the nurse (Employee #2) to respond, and the nurse came over, silenced the alarm, and then walked away. P#1 reported that another PCT (Employee #3) had to lay her flat on her treatment chair and administered normal saline. P#1 stated that she recalled hearing Employee #3 (patient care technician), asking the nurse (Employee #2) why she refused to help. After completing her treatment that day, P#1 informed the Administrative Assistant that she was afraid when the nurse (Employee #2) was working, stating, that Employee #2 never left her desk to come help. The Administrative Assistant provided her with a grievance form, which she completed and placed inside the window at the front desk (Administrative Assistant’s office). When P#1 returned for treatment on 7/8/25, P#1 reported feeling tearful and afraid. The Facility Administrator approached her while she was in her treatment chair and P#1 explained the situation, stating that she did not want the nurse (Employee #2), involved in her care and requested a meeting with the Facility Administrator’s supervisor and P#1’s doctor. P#1 also informed the Facility Administrator that she had filed a grievance. A few days later, P#1 was told that the grievance form she wrote and filed could not be found. P#1 stated that she then submitted a second written grievance, (written on a piece of paper). That second written grievance also reportedly went missing. P#1 expressed feeling frightened because her grievance was not addressed and was not resolved. P#1 further stated that the Facility Administrator did not care. During an interview conducted on 8/27/25 at 12:00 p.m., Employee #2 stated that P#1’s BP reading had dropped while she was completing her dialysis treatment. She stated she was informed of this by Employee #1, and at the time, Employee #2 was waiting for Employee #1 to recheck P#1’s BP. On the same day (7/5/25), the Administrative Assistant informed her (Employee #2) that P#1 had submitted a complaint about her. However, when she checked the designated window where complaint forms were typically placed, Employee #2 stated that she did not find it and did not take the grievance form. Employee #2 further stated that she wanted to clarify that she did not take or remove the complaint form. The following day (7/6/25), the Facility Administrator held a meeting regarding the missing grievance form. During that meeting, all staff were instructed not to provide patients with grievance forms. Approximately a week later, the Facility Administrator located the grievance form in the large, locked container for documents to be shredded. Employee #2 further stated that the Facility Administrator called her into the office and allowed her to read it. Employee #2 also stated that she was not counseled to avoid the patient, and was not issued a write-up regarding the incident. At one point, Employee #2 stated that she attempted to insert P#1’s fistula needles, but P#1 declined and requested that someone else perform the procedure. During an interview with the Regional Operations Director on 8/28/25, at 11:00 a.m., she stated that the Facility Administrator informed her that the nurse (Employee #2) admitted to removing the grievance form from the Administrative Assistant’s window. She also stated that, due to her responsibilities overseeing multiple facilities and other duties, Facility Administrators were responsible for the direct oversight of their individual locations. She added that from their discussion, it was understood that Employee #2 was to be counseled and written up for taking a patient’s grievance form and placing it in the large locked bin where documents to be shredded, were kept. On 8/28/25, at 11:30 a.m., a call was placed to the Medical Director, and a message was left requesting a return call, but the Medical Director did not return this surveyor’s call. A review of the Governing Body Meeting Minutes for the month of July 2025 and August 2025, showed no documented evidence of action plans regarding P#1’s complaints and resolution. A review of Policy #3-01-07A, titled, “PATIENT’S RIGHTS”, revised April 2025, stated: YOUR RIGHTS AS A PATIENT: Page 1. 8. To receive adequate, safe, sanitary, and efficient dialysis treatment and respectful care by competent personnel in a comfortable environment. Page 3. 30. To freely express comments, complaints, or grievances verbally or in writing personally, anonymously, or through a representative of my choosing. My comments, complaints and grievances may be expressed to the Facility Administror (FA) at your facility who is the Civil Rights Coordinator (CRC), other facility teammates, administration, DaVita’s Corporate Compliance Department, the ESRD Network organization and appropriate regulatory agencies withour fear of reprisal or denial of services, descrimination or retaliation. All comments, complaints and grievances will be resolved in a timely manner. A review of Policy #3-01-06, titled, “PATIENT GRIEVANCE”, revised April 2025, stated: Page 1. Grievance, Generally: A. ALL DaVita patients have the right to have their grievance handled promptly and courteously. F. It is against the law for DaVita to retaliate against anyone who files a grievance or cooperates in the investigation of a grievance. Internal Grievance Process: A. Grievances may be reported to a DaVita teammate either verbally or in writing. Grievance should be submitted to a DaVita teamate within 30 days of the date of the incident or when the person filing the grievance on behalf of the patient became aware of the issue. B. The DaVita teammate should report the grievance to the charge nurse. If a solution to the grievance is not reached through this discussion, the charge nurse is to notify the FA and the Regional Operations Director (ROD) within one business day for a follow up. C. The FA (or their designee) is to discuss the grievance with the patient, investigate and take appropriate action toward a solution, if possible. This discussion should occur within 10 days of receipt of the grievance. If the patient’s grievance cannot be resolved by the FA, the ROD and Medical Director will be notified and a formal grievance confrence will be coordinated. This grievance conference should occur within 10 days of receipt of the grievance. A review of the Governing Body Bylaws stated: Article III: Management 3.1. Operational Management of Facility. The Governing Body shall maintain responsibility for governance and operation of the facility. The Governing Body shall: a. Adopt, enforce and review annually for appropriateness, policies, rules and regulations relative to i) it own governance, ii) the health and safety of Facility patients, iii) protection of the patients’ personal and property rights, and iv) the general operation of the facility. 3.2. Quality of Care. The Governing Body shall ensure the health and safety of Facility patients and shall: (i) Take such other actions as it deems necessary to ensure the facility provides quality care to its patients and provides a safe enviroment for its teamates. 4.3. Administrator / Chief Executive Officer The Administrator shall at a minimun, in collaboration with the other GB Members: (a) Provide overall management, educate on and enforce the rules, regulations and policies of the Facility and applicable, federal, state and local laws and regulations as directed by the Governing Body. (c) Organize and coordinate the administrative functions of the Facility, delegate duties as authorized, and establish formal means of accountabality for those involved in patient care. (e) Ensure that the facility (i) employs the number of qualified personnel needed to safely and effectively operate the facility, (ii) provide all teammates with appropriate orientation to the Facility and their work responsibilities and (iii) provide a safe work enviroment that is free from harassment, intimidation or discrimination.”