Davita North Henry Dialysis

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 50523 Based on a review of records and Policy and Procedures (P&P), and staff interviews, it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT AA) who cared for one of one patient (P#1) sampled, who presented for dialysis with 3.4 kilograms (kg) of fluids over her estimated dry weight (EDW) on 12/9/24, failed to monitor P#1’s fluid removal rate (UFR) during over three hours of dialysis treatment; and one of one Registered Nurse (RN DD) failed to verify and confirm the UFR setting within one hour of treatment initiation per P&P, to meet P#1’s goal for fluid removal. This deficient practice resulted in P#1’s hospitalization due to fluid overload associated with difficulty breathing that necessitated intubation [insertion of a tube through a person’s mouth or nose, then down into the trachea (airway/windpipe) as a form of life support to keep the airway open and assist breathing]. Findings include: Cross reference V 543 - Failure of PCT AA and RN DD to provide the necessary care and services to manage the patient’s volume status per facility P&P.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on patient record review, a review of facility Policies and Procedures (P&P) and staff interviews, it was determined that the Governing Body (GB) failed to demonstrate responsibility and accountability for the operations of the facility. This deficient practice resulted in P#1’s hospitalization due to fluid overload associated with difficulty breathing that necessitated intubation [insertion of a tube through a person’s mouth or nose, then down into the trachea (airway/windpipe) as a form of life support to keep the airway open and assist breathing]. The facility census was 116. Findings include: Cross references: V 543 - Failure of the GB to ensure that Patient Care Technician (PCT) AA and Registered Nurse (RN) DD provided the necessary care and services to manage the patient’s volume status. V 715 - Failure of the GB to ensure that the medical director demonstated responsibility for the implementation of the P&P by all staff. V 757 - Failure of the GB to ensure that the facility had sufficient qualified staff to meet the needs of all patients and provide safe patient care.”

“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: 50523 Based on a review of records and Policy and Procedures (P&P), and staff interviews, it was determined that the Interdisciplinary Team (IDT) failed to ensure that one of one patient (P#1) sampled, who presented for dialysis with 3.4 kilograms (kg) of fluids over her estimated dry weight (EDW), received medical care/interventions appropriate to her dialysis needs. One of one Patient Care Technician (PCT AA) who cared for P#1 on 12/9/24, failed to monitor P#1’s fluid removal rate (UFR) during over three hours of dialysis treatment; and one of one Registered Nurse (RN DD) failed to verify and confirm the UFR setting within one hour of treatment initiation per P&P, to meet P#1’s goal for fluid removal. This deficient practice resulted in P#1’s hospitalization due to fluid overload associated with difficulty breathing that necessitated intubation [insertion of a tube through a person’s mouth or nose, then down into the trachea (airway/windpipe) as a form of life support to keep the airway open and assist breathing]. Findings include: A review of P#1’s “Treatment Details Report” dated 12/9/24 showed the following: - P#1’s pre weight (weight before dialysis) was 70.9 kg. P#1’s EDW was 67.5 kg. P#1 was 3.4 kg over her EDW. - Pre treatment fluid calculation showed P#1’s machine was set to remove 3,600 milliliters (mL) within three hours and 45 minutes per ordered treatment duration; with an estimated UFR of 12.19 ml/kg/hr (milliliters/kilograms/hours). -The intradialytic (during hemodialysis) data showed the following: At 7:06 a.m., P#1’s treatment began with the UFR at zero and the total fluid volume removed was zero. At 8:09 a.m., P#1’s UFR was zero and the total fluid volume removed was zero. At 8:36 a.m., P#1’s UFR was zero and the total fluid volume removed was zero. At 9:06 a.m., P#1’s UFR was zero and the total fluid volume removed was zero. At 9:39 a.m., P#1’s UFR was zero and the total fluid volume removed was zero. At 10:06 a.m., P#1’s UFR was zero and the total fluid volume removed was zero. At 10:36 a.m., P#1’s UFR was zero and the total fluid volume removed was zero. At 10:47 a.m., P#1’s UFR was 9.30 ml/kg/hr and the total fluid volume removed was 12 mL. At 10:53 a.m. P#1’s treatment ended with the UFR at zero and the total fluid volume removed was 45 mL. This facility used an interactive system, which accepted input and captured data from the hemodialysis machine into electronic “Treatment Details Report”. There was a lack of documented evidence that PCT AA nor RN DD monitored P#1’s fluid removal every 30 minutes per P&P for at least over three hours during dialysis treatment, as evidenced by 45 mL total amount of fluid removed instead of 3,600 mL, which was the goal for fluid removal. - P#1’s post dialysis weight was 71.3 kg, which was 3.8 kg (3,800 mL) over her EDW. - There was no documentation in P#1’s “Treatment Details Report” dated 12/9/24, from neither PCT AA nor RN AA that addressed abnormal findings related to P#1’s fluid status post dialysis treatment. There was a lack of documented intervention in P#1’s “Treatment Details Report” dated 12/9/24. - A review of the “ED (Emergency Department) Provider Note” dated 12/10/24 revealed the following: P#1 arrived in the ED on 12/10/24 at 4:16 p.m., complaining of shortness of breath since 2:00 a.m. At 5:40 p.m., P#1 “appeared to be fluid overloaded and extremely hypertensive”. At 7:10 p.m., P#1 was having worsening respiratory distress (difficulty breathing). At 7:34 p.m., P#1 was intubated. P#1’s diagnoses were: ESRD (End Stage Renal Disease), dyspnea (shortness of breath), hypervolemia (fluid overload), and acute hypoxic respiratory (a rapid onset of respiratory distress caused by low oxygen in the body, where fluid builds up in the lungs, preventing proper gas exchange). - A review of “Patient Note” created by the Registered Dietician (RD) dated 12/10/24 at 3:05 p.m., showed P#1 left 2 kg over target weight on 12/9/24. Tech stated machine did not work and did not pull fluid correctly. Tech offered patient extra treatment; patient declined. - During an interview on 12/16/24 at 12:14 p.m., PCT AA stated she realized that P#1 didn’t remove the total fluid volume that the machine was set to be removed at the initiation of P#1’s treatment. PCT AA stated that the UF couldn’t have been on during P#1’s treatment. PCT AA stated she did not know why the UF wasn’t on because typically the UF automatically comes on when starting a patient’s treatment. PCT AA also stated that an extra treatment for fluid removal was offered to P#1 to come in on 12/10/24 but P#1 declined the offer. However, there was a lack of documented evidence in P#1’s “Treatment Details Report” dated 12/9/24 that an extra treatment was offered. During a telephonic interview with the MD on 12/16/24 at 3:20 p.m., MD stated he was made aware on 12/12/24 of the situation regarding the staff not ensuring that P#1 received treatment as prescribed. The MD also stated that from the facility’s investigation, P#1’s UFR was not on for most of P#1’s treatment to be able to pull the necessary amount of fluid volume as prescribed. On 12/16/24 at 3:50 p.m., LPN AA stated that it was very easy to make a mistake because she had to set up and prepared each machine for dialysis, initiated treatments, monitored patients during dialysis, and removed used bloodlines after termination of dialysis for all four patients, and disinfected each machine and patient’s chair before the next shift. LPN AA also stated she was pulled everywhere because she had to perform assessments and administered medications for six more patients outside of the four in her Pod. During an interview on 12/16/24 at 4:02 p.m., RN CC stated she felt overburdened and felt as if patient’s safety was endangered. RN CC stated she found it difficult to keep up with everything that needed to be completed such as administering medications and performing pre and post-assessments for patients whose care she oversaw in addition to the actual patients assigned to her. RN AA was not available for interview during the investigation. - A review of facility Policy: 1-03-08 titled, “Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment” with latest revision date of April 2024, showed the following: 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one hour of treatment initiation along with nursing assessment ... Prescription components include but are not necessarily limited to ... C. Target Weight D. URF and Max UFR Interdialytic Data Collection Assessment 9. Interdialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. Vitals signs and treatment monitoring ... iii. Non-nocturnal treatments are completed at least every 30 minutes. b. At a minimum, obtain and document the following: iv. Fluid removal and/ or replacement. Post Treatment Data Collection Assessment 15. The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and compare to pre-dialysis findings. 16. If an abnormal finding (s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17. Licensed nurse will use their clinical judgement based on individual patient needs to determine if any clinical interventions or notification of physician is necessary prior to discharge of the patient from the facility. Abnormal Findings Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Fluid Status: Post-treatment: If patient is above or below 1kg from the target weight (EDW) ...”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 50523 Based on a review of records and Policy and Procedures (P&P), and staff interviews, it was determined that the Medical Director (MD) failed to ensure that one of one Patient Care Technician (PCT AA) who cared for one of one patient (P#1) sampled, who presented for dialysis with 3.4 kilograms (kg) of fluids over her estimated dry weight (EDW) on 12/9/24, failed to monitor P#1’s fluid removal rate (UFR) during over three hours of dialysis treatment; and one of one Registered Nurse (RN DD) failed to verify and confirm the UFR setting within one hour of treatment initiation per P&P, to meet P#1’s goal for fluid removal. This deficient practice resulted in P#1’s hospitalization due to fluid overload associated with difficulty breathing that necessitated intubation [insertion of a tube through a person’s mouth or nose, then down into the trachea (airway/windpipe) as a form of life support to keep the airway open and assist breathing]. Findings include: Cross reference V 543 - Failure of PCT AA and RN DD to provide the necessary care and services to manage the patient’s volume status per facility P&P. During a telephonic interview with the MD on 12/16/24 at 3:20 p.m., MD stated he was made aware on 12/12/24 of the situation regarding the staff not ensuring that P#1 received treatment as prescribed. The MD also stated that from the facility’s investigation, P#1’s UFR was not on for most of P#1’s treatment to be able to pull the necessary amount of fluid volume as prescribed.”

“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 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 116 patients who dialyzed at this facility. Findings include: A review of staff assignments and “Patient and Teammate Schedule/Daily Assignments” for the first shift on 12/16/24 revealed the facility had seven Pods with four Stations (S) in each Pod. Staffing consisted of five PCTs (PCT AA, PCT BB, PCT CC, PCT DD, and PCT EE), one Licensed Practical Nurse (LPN) (LPN AA), two Registered Nurses (RN) [RN/Charge Nurse (CN) BB and RN CC], who were assigned to care for 28 patients across seven Pods. - Pod 1: PCT BB was assigned to care for patients at S1, S2, S3, and S31. - Pod 2: RN CC was assigned to care for patients at S4, S5, S6, and S7. All patient’s 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 LPN. - Pod 3: PCT AA was assigned to care for patients at S8, S9, S10 and S11. - Pod 4: LPN AA was assigned to care for patients at S12, S13, S15, and S18. Two of four patients had a CVC. - Pod 5: PCT CC was assigned to care for patients at S19, S20, S25 and S26. - Pod 6: PCT DD was assigned to care for patients at S27, S28, S29, and S30. - Pod 7: PCT EE was assigned to care for patients at S14, S16, S17, and S21. RN CC and LPN AA functioned as patient care givers, who provided total care to four patients each. RN/CN BB was the only nurse who was supposed to provide nursing care/tasks including, but not limited to pre and post dialysis assessments, preparation and administration of medications, and oversee the care rendered to the other 20 patients who were assigned to PCT AA, PCT BB, PCT CC, PCT DD, and PCT EE. During an interview on 12/16/24 at 3:29 p.m., RN/CN BB stated the nurses always had an assigned Pod and were required to do patient assessments and pass medications for more patients, in addition to patients in their assigned Pods. RN/CN BB also stated that there were times that she also had to take a Pod in addition to her duties and responsibilities as the CN, due to not having enough staff. On 12/16/24 at 3:50 p.m., LPN AA stated that it was very easy to make a mistake because she had to set up and prepared each machine for dialysis, initiated treatments, monitored patients during dialysis, and removed used bloodlines after termination of dialysis for all four patients, and disinfected each machine and patient’s chair before the next shift. LPN AA also stated she was being pulled everywhere because she had to perform assessments and administered medications for six other patients in addition to the four patients who were assigned to her, in her own Pod. During an interview on 12/16/24 at 4:02 p.m., RN CC stated she felt overburdened and felt as if patient’s safety was endangered. RN CC stated she found it difficult to keep up with everything that needed to be completed such as administering medications and performing pre and post assessments for patients, whose care she oversaw in addition to the four patients in her Pod, who were assigned to her.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 33921 Based on observations, staff interviews, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility Policy and Procedures (P&P), it was determined that the facility failed to ensure that 12 of 12 staff (LPN AA, LPN BB, LPN CC, LPN DD, RN AA, PCT AA, PCT BB, PCT CC, PCT DD, PCT EE, PCT FF, and PCT GG) observed, practiced infection control techniques to prevent transmission of dangerous pathogens in the hemodialysis unit. This deficient practice had the potential to negatively affect the health and safety of all 122 in-center hemodialysis patients who were receiving dialysis at this facility. Findings include: Cross references: V 113 - Failure of the Direct Patient Care Staff, (Licensed Practical Nurses LPN AA, LPN BB and LPN CC), one of one Caregiver (CG AA), and five of five patients (P) (P#12, P#14, P#15, P#16 and P#17) observed, as well as failure of the staff to remind the patients to perform hand hygiene after their hemodialysis treatment. V 115 - Failure of Direct Patient Care Staff (Registered Nurse - RN AA) to make sure that patient (P) (P#11), wore her Personal Protective Equipment (PPE) mask appropriately during initiation of hemodialysis treatment using Central Venous Catheter. V 117 - Failure of Direct Patient Care Staff (Patient Care Technicians-(PCT BB and PCT EE), to utilize appropriate infection control techniques to prevent cross contamination. V 122 - Failure of Direct Patient Care Staff (RN AA, LPNs AA, BB, CC and DD, PCTs AA, BB, CC, DD, FF and GG) to clean and disinfect surfaces that were contaminated with blood or body fluids.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 33921 Based on observation and staff interviews, it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT CC) and one of one Licensed Practical Nurse (LPN CC) observed, followed the Manufacturer’s Directions For Use (DFU) and the facility’s Policy and Procedure (P&P) regarding testing the machines’ dialysate pH (Acidity) using RPC K100-0117 E-Z Check 6.8 - 8.5CT pH strips, and Conductivity (dialysate’s ability to conduct electricity), in order to provide safe treatments for all patients. Failure to follow the Manufacturer’s DFU for testing the dialysate’s pH and Conductivity, may result in inaccurate test results, and had the potential to cause harm to 122 in-center hemodialysis patients who dialyzed at this facility. Findings include: Cross Reference: V 250 - Failure of the facility to ensure that one of one Patient Care Technician, (PCT CC) and one of one Licensed Practical Nurse (LPN CC), followed the Manufacturer’s Directions For Use (DFU) and the facility’s Policy and Procedure (P&P) regarding testing the machines’ dialysate pH (Acidity) using RPC K100-0117 E-Z Check 6.8 - 8.5CT pH strips and independent testing of Conductivity prior to each patient treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 33921 Based on observations, facility record review, staff interviews, and a review of the Centers for Disease Control and Prevention (CDC) Recommendations, 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 122 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross References: V 113 - Failure of the Direct Patient Care Staff, (Licensed Practical Nurses LPN AA, LPN BB and LPN CC), one of one Caregiver (CG AA), and five of five patients (P) (P#12, P#14, P#15, P#16 and P#17) observed, as well as failure of the staff to remind the patients to perform hand hygiene after their hemodialysis treatment. V 115 - Failure of Direct Patient Care Staff (Registered Nurse - RN AA) to make sure that patient (P) (P#11), wore her Personal Protective Equipment (PPE) mask appropriately during initiation of hemodialysis treatment using Central Venous Catheter. V 117 - Failure of Direct Patient Care Staff (PCT BB and PCT EE), to utilize appropriate infection control techniques to prevent cross contamination. V 122 - Failure of Direct Patient Care Staff (RN AA, LPNs AA, BB, CC and DD, PCTs AA, BB, CC, DD, FF and GG) to clean and disinfect surfaces that were contaminated with blood or body fluids. V 250 - Failure of the facility to ensure that one of one Patient Care Technician, (PCT CC) and one of one Licensed Practical Nurse (LPN CC), followed the Manufacturer’s Directions For Use (DFU) and the facility’s Policy and Procedure (P&P) regarding testing the machines’ dialysate pH (Acidity) using RPC K100-0117 E-Z Check 6.8 - 8.5CT pH strips and independent testing of Conductivity prior to each patient treatment.”

“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: 33921 Based on observations, staff and caregiver interviews, a review of facility Policy and Procedure, and Centers for Disease Control and Prevention (CDC) Recommendations, it was determined that the Infection Control Committee failed to ensure that three of three Licensed Practical Nurses (LPN AA, LPN BB and LPN CC), one of one Caregiver (CG AA), and five of five patients (P) (P#12, P#14, P#15, P#16 and P#17) at Stations (S) 18, 26, 28, 31 (Isolation Room), and S6 observed respectively, performed hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes and after touching contaminated equipment. Failure to perform infection control techniques such as hand hygiene, increases the risk for cross contamination with the potential to expose patients and staff to blood-borne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect all 122 in-center hemodialysis patients who dialyzed at this facility and all 23 Direct Patient Care Staff (Registered Nurses, LPNs, and Patient Care Technicians). Findings include: During observation in the Patient Treatment Room on 12/13/23 between 10:35 a.m. and 1:00 p.m., the following was revealed: - LPN BB was observed during the initiation of hemodialysis treatment of P#12, who had a Central Venous Catheter (CVC - a type of access used for hemodialysis where a soft plastic tube is inserted under the skin and into a large central vein ), at S18. LPN BB did not perform hand hygiene between glove changes. In addition, LPN BB obtained a sterile syringe (clean) from the common supply area without performing hand hygiene after removing her soiled gloves (dirty). After LPN BB administered the Heparin (anticoagulant) Bolus to P#12, LPN BB removed her used glove (dirty) from her right hand, then without performing hand hygiene, LPN BB touched the computer keys (considered clean) to document her data. - P#14’s Caregiver (CG AA), was sitting next to P#14 at S28, to prevent P#14 from pulling his fistula needles out. CG AA pushed the sharps container towards the back of S28, without wearing gloves and without performing hand hygiene after moving the sharps container. CG AA was also observed touching her face and cellphone after moving the sharps container. LPN AA stated on 12/13/23 at 12:30 p.m. that the staff told CG AA to wear her personal protective equipment (PPE) while staying with P#14. CG AA stated on 12/13/23 at 12:35 p.m. that she was told to wear a gown but was never told to wear gloves. There was no documentary evidence that CG AA was educated on infection control techniques and the necessity of wearing gloves and/or performing hand hygiene when touching contaminated objects such as a sharps container. There was no documentary evidence that CG AA was educated on the risk of handling sharps containers. On 12/14/23 at 11:57 a.m., during a follow up observation, the sharps container had small drops of dried blood on its side. LPN AA who was present during this follow up observation on 12/14/23 at 12:00 p.m., acknowledged the presence of dried blood on the side of the sharps container. - P#15 was positive for Hepatitis B Virus and was treated in the Isolation Room. P#15 held his access site wearing a glove on his right hand. P#15 did not perform hand hygiene before leaving the Isolation room and before leaving the treatment room. LPN AA (Charge Nurse), did not remind nor instruct P#15 to wash his hands before leaving the Isolation Room and before leaving the treatment room. LPN AA stated on 12/13/23 at 11:45 a.m., that she was not aware P#15 did not perform hand hygiene before leaving the Isolation Room and treatment room (even when LPN AA escorted P#15 to the weighing scale). - LPN CC was observed during initiation of hemodialysis to P#16 at S13 with a CVC. LPN CC did not perform hand hygiene between glove changes. - On 12/14/23, at 11:45 a.m., P#17 was holding his access site wearing a glove at S6. Without removing his used glove and without performing hand hygiene, P#17 removed his blood pressure (BP) cuff then walked to the weighing scale and touched the screen with his used glove. P#17 tore the paper off its dispenser that had his recorded weight and went back to S6, placing the paper with the recorded weight under the computer mouse (considered clean). The Regional Operations Director was informed of this observation on 12/14/23 at 11:55 a.m., and stated that the computer mouse should be disinfected. - A review of the facility’s Policy #1-05-01 titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene: b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse 2. Patients and caregivers will be encouraged to: a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area... 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 ...”

“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: 33921 Based on observation, staff interview, and a review of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI ) Vascular Access Guidelines, it was determined that the facility failed to ensure that one of one Registered Nurse (RN AA) observed, made sure that Patient (P) #11, at Station (S) 3, wore her mask appropriately during the initiation of P#11’s hemodialysis treatment, using a Central Venous Catheter (CVC - a type of access used for hemodialysis where a soft plastic tube is inserted under the skin and into a large central vein ). This deficient practice had the potential to negatively affect the health and safety of P#11 and the other 30 patients who were using a CVC as their primary access at this facility. The in-center census was 122. Findings include: During observation in the patients’ treatment room on 12/13/23 between 10:35 a.m. and 1:00 p.m., the following was revealed: - RN AA was initiating hemodialysis treatment on P#11 at S3, using a CVC. P#11 had her mask below her nostrils during the whole procedure, including CVC dressing change and during the “scrub the hub” procedure, when the exit site and catheter lumens were exposed. RN AA did not remind and did not make sure P#11 wore her mask appropriately during the whole procedure. RN AA stated on 12/13/23 at 1:00 p.m. that he was not aware P#11’s mask was below her nose during the procedure. - A review of the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) Vascular Access Guidelines stated “Airborne contaminants from both patients and staff are prevented best by the use of surgical masks when the catheter lumens or exit site are exposed”.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 33921 Based on observation, a review of the Centers for Disease Control and Prevention (CDC) guidelines and recommendations, and staff interview, it was determined that the Infection Control Committee failed to ensure that two of two Patient Care Technicians (PCT BB and PCT EE) observed during initiation of hemodialysis treatment of two of two Patients (P) (P#13 and P#18), with an arterio-venous fistula (AVF - dialysis access), utilized appropriate infection control techniques to prevent cross contamination. This deficient practice had the potential to negatively affect the health and safety of P#13 and P#18. The facility census was 122. Findings include: During observation in the Patient Treatment Room on 12/13/23 between 10:35 a.m. and 1:00 p.m., the following was revealed: - PCT BB was observed during initiation of hemodialysis treatment on P#13 at S26 with an AVF. PCT BB inserted the arterial needle after disinfection, then using the same glove, PCT BB reset the machine’s alarm. PCT BB touched the disinfected venous site with the dirty glove before inserting the venous needle, thus re-contaminating the disinfected site. PCT BB stated on 12/13/23 at 11:50 a.m., that he didn’t realize he had re-contaminated the access site. - PCT EE was observed during initiation of hemodialysis on P#18 at S27. PCT EE touched the disinfected area before fistula needle insertion, thus re-contaminating the access sites. - According to the CDC, cross contaminating (going from dirty to clean equipment/tasks/area), could cause the spread of bacteria/infections.”

“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: 33921 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 Infection Control Committee failed to ensure that one of one Registered Nurse (RN AA), four of four Licensed Practical Nurses (LPNs AA, BB, CC and DD) and six of six Patient Care Technicians (PCTs AA, BB, CC, DD, FF and GG), who were present during this observation, immediately and thoroughly cleaned and disinfected blood-contaminated surfaces on the cover of four of 15 sharps containers observed at/or between Stations (S) 13, 21, 22 and 28, 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 nine of nine in-center hemodialysis patients (P) (P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, and P#20), who were undergoing hemodialysis treatment at the time of this observation and one of one Caregiver (CG AA), who was watching over P#14 at S28. Findings include: During observation in the Patient Treatment Room on 12/13/23 between 10:35 a.m. and 1:00 p.m., there were four sharps containers observed at/between S13, S21, S22 and S28, that had one - four dried drops of blood on the top covers of the sharps containers and on the side, and were not cleaned and disinfected between patient use. 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 the facility’s Policy #1-05-01 titled, “Infection Control for Dialysis Facilities” with latest revision date of April 2023, stated: Disinfection: 12. Cleaning and disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials...”

“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: 33921 Based on observation, staff interview, and a review of facility records, it was determined that the facility failed to ensure that there was a safe environment for 122 In-Center hemodialysis (ICHD) patients as evidenced by failure of one of one Licensed Practical Nurse (LPN CC) and one of one Patient Care Technician (PCT CC) to follow the Manufacturer’s Directions For Use (DFU) and the facility’s Policy and Procedure (P&P) regarding testing the machines’ dialysate pH (Acidity) using RPC K100-0117 E-Z Check 6.8 - 8.5CT pH strips and failure of PCT CC to perform an independent Conductivity (ability of the dialysate to conduct electricity) testing prior to initiating Patient (P) #21’s dialysis treatment at Station (S) 26. This failure had the potential to negatively affect the health and safety of P#21 and the other nine ICHD patients (P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, and P#20), who were undergoing hemodialysis treatment at the time of this observation. Findings were: During observation in the Patient Treatment Room on 12/13/23 between 10:35 a.m. and 1:00 p.m., the following was revealed: - LPN CC was observed initiating P#21’s hemodialysis treatment without first testing the machine’s dialysate for pH and Conductivity. LPN CC stated on 12/13/23 at 11:35 a.m. that there was a new facility policy that stated they didn’t need to test the dialysate for pH and Conductivity anymore prior to patient treatment. This surveyor told LPN CC that since they’re using Fresenius 2008K2, the manufacturer’s Direction for Use (DFU) had not changed and independent pH and Conductivity was still to be performed prior to each patient treatment. LPN CC proceeded to perform pH testing using (RPC K100-0117 E-Z Check 6.8 - 8.5CT pH strip) but did not wait 10 seconds for the color on the strip to develop for accurate results, per manufacturer’s DFU. - PCT CC was observed testing the dialysate sample for pH from S26, at 11:45 a.m., using RPC K100-0117 E-Z Check 6.8 - 8.5CT pH strip. PCT CC also did not use the clock or timer and did not perform the testing according to the manufacturer’s DFU. The Facility Administrator was notified of this observation on 12/13/23 at 11:50 a.m. The Facility Administrator announced to all the Direct Patient Care Staff that independent testing of the dialysate’s pH and Conductivity must be performed prior to each patient treatment and reviewed the facility Policy and Procedure with all Direct Patient Care Staff. - A review of the Manufacturer’s DFU and the facility’s Procedure: 2-08-01P titled, “Testing pH of Citric Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8 - 8.5 Test Strips, with latest revision date of October, 2020, stated: 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. At 10 seconds, immediately compare the color reaction on strip to the color chart on bottle to determine the closest match. - A review of Policy: 1-03-02, titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate”, with latest revision date of April 2020, stated: 5. When applicable, the final dialysate conductivity should be checked with approved independent meter... 6. Independent pH is required to be performed prior to each treatment.”