Davita Sylacauga Dialysis

“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: 30952 Based on observations, the Centers for Medicare and Medicaid Services (CMS) ESRD (End Stage Renal Disease) Core Survey Observations of Hemodialysis Care and Infection Control (IC) Practices, facility policy, and staff interviews, it was determined the facility failed to ensure staff followed recommended infection control practices and facility policy for gloving and hand hygiene during: a. One of three observations to verify dialysis prescriptions. b. Two of two observations for access of AVF/AVG (arteriovenous fistula/graft) for initiation of dialysis. In addition, the facility failed to ensure Patient Care staff followed the facility policy for nails and nail length. This affected Patient Identifier (PI) # 6, PI # 7, had the potential to negatively affect all 35 incenter patients who dialyze at the facility. Findings include: CMS ESRD Core Survey Version 1.6 Access of AVF or Graft for Initiation of Dialysis... ...Action ...Wash skin over access with soap and water... Evaluate access: Locate/palpate... Hand Hygiene (remove gloves, if worn); don clean gloves... Apply antiseptic to skin over cannulation sites... Facility Policy Title: Infection Control for Dialysis Facilities Policy: 1-05-01 Revision Date: April 2023 Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ...Policy: The Center for Disease Control (CDC) recommendations... will be followed... Hand Hygiene 1. All teammate...perform hand hygiene b. prior to gloving and immediately after glove removal... 4. It is a requirement for all DaVita teammates...working in a facility to have only natural nails and fingernail length...not more than 1/4 (one quarter) inch... PPE (Personal Protective Equipment) ...gloves 5. Appropriate PPE will be worn whenever there is a potential for contact with body fluids... 7. Disposable gloves will be worn when...touching the patient’s equipment at the dialysis station... 1. During the incenter treatment floor flash tour on 7/22/24 at 8:50 AM, the surveyor verified the dialysis prescription with Employee Identifier (EI) # 4, Registered Nurse, for an unsampled patient at station 9. EI # 4 repositioned the dialyzer on the dialysis machine with bare hands. EI # 4 failed to wear gloves when touching the dialysis machine. An interview was conducted on 7/24/24 at 1:49 PM with EI # 1, Facility Administrator, and EI # 2, Manager of Clinical Services, who confirmed the staff failed to follow facility policy for hand hygiene. 2. An observation was conducted on 7/22/24 at 9:55 AM on the incenter treatment floor with EI # 7, Certified Clinical Hemodialysis Technician (CCHT), to initiate dialysis for PI # 6 with an AVF/AVG at station 15. EI # 7 palpated and auscultated PI # 6’s access sites but failed to perform hand hygiene and don clean gloves before site antisepsis. An interview was conducted on 7/24/24 at 1:49 PM with EI # 2 who confirmed staff should perform hand hygiene after access evaluation. 3. An observation was conducted on 7/22/24 at 11:35 AM on the incenter floor with EI # 8, CCHT, to initiate dialysis for PI # 7 with an AVF/AVG at station 2. EI # 8 palpated and auscultated PI # 7’s cannulation sites but failed to remove gloves and perform hand hygiene before access site antisepsis. An interview was conducted on 7/24/24 at 1:49 PM with EI # 2 who confirmed the staff should perform hand hygiene after access evaluation. 4. During the ESRD CORE survey interview on 7/22/24 at 2:30 PM, the surveyor observed EI # 7 had artificial nails, and the nail length was greater than facility policy of one quarter inch. EI # 7 confirmed on 7/22/24 at 2:30 PM his/her nails were not natural, and the length was greater than what was allowed per policy. An interview was conducted on 7/24/24 at 1:49 PM with EI # 1 who confirmed staff failed to follow the facility policy for nails.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 30952 Based on observation, review of facility policy, and interviews, it was determined the facility failed to ensure Home Program staff followed their own policies for disposal of contaminated items. This affected one of one observation conducted in the Peritoneal Dialysis (PD) Home Training area during the facility flash tour. This had the potential to negatively affect the seven PD patients treated at the facility, staff, and visitors. Findings include: Facility Policy Title: Disposal of PD Effluent (abdominal cavity drainage) in the Facility Policy: 5-06-06 Revision Date: March 2013 ...Policy: 1. The PD teammates will follow Occupational Safety and Health Administration ...dialysis precautions for handling...body fluids...potentially infectious...body fluids... 2. Empty all PD effluent in a designated ‘dirty’ sink, commode or hopper... 5. Empty PD effluent bags should be...placed in leak proof red biohazard plastic bags...in medical waste room... 1. A tour of the Home PD Program Training/Exam rooms on 7/22/24 at 12:10 PM revealed a bag of golden yellow colored fluid, not labeled, (possible PD effluent) in the clean sink at the home training station. An interview was conducted on 7/22/24 at 12:12 PM with Employee Identified (EI) # 1, Facility Administrator, who confirmed the bag of yellow golden fluid in the clean sink was PD effluent. EI # 1 confirmed the PD effluent bag should not be in the clean sink. An interview was conducted on 7/23/24 at 11:10 AM with EI # 6, PD Home Program Registered Nurse, who reported the last patient treated in the Home Training room was on 7/19/24. EI # 6 confirmed the PD effluent bag should not have been placed in the clean sink.Based on observation, review of facility policy, and interviews, it was determined the facility failed to ensure Home Program staff followed their own policies for disposal of contaminated items.”

“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: 30952 Based on observation, facility procedure, and interview, it was determined the staff failed to ensure patients with a CVC (Central Venous Catheter (CVC) wore a face mask that covered his/her nose during CVC exit site care and dialysis treatment initiation. This affected Patient Identifier (PI) # 9, in one of two CVC exit site care and treatment initiation observations and had the potential to negatively affect all CVC patients who dialyze at the facility. Findings include: Facility Procedure: Central Venous Catheter with Clearguard HD (Hemodialysis) Antimicrobial End Caps Procedure Procedure: 1-04-02B Revision Date: October 2023 ...Notes: Use Dialysis Precautions and aseptic techniques throughout procedure. Procedure: 1. ...Teammate and patient will wear masks covering the nose and mouth during this procedure ... These measures are vital to preventing the exposure of the catheter and exit site to nasal droplets and infectious bacteria ... 1. An observation was conducted on 7/22/24 at 10:25 AM on the incenter treatment floor to observe Employee Identifier (EI) # 5, Registered Nurse (RN) perform CVC exit site care and initiate dialysis on PI # 9 at station 17. PI # 9’s face mask was worn below the level of the nose during the entire CVC exit care and treatment initiation. EI # 5 failed to instruct and ensure PI # 9 wore the face mask above the bridge of the nose. An interview was conducted on 7/24/24 at 1:49 PM with EI # 1, Facility Administrator, who confirmed staff failed to ensure PI # 9’s face mask covered his/her nose.”

“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: 30952 Based on observations, facility policy and procedure, and interview, it was determined the facility failed to ensure staff: 1. Stored bleach solution according to procedure. 2. Cleaned and disinfected the dialysis station between patients. This affected one of two incenter observations of dialysis station disinfection, and the flash tour of the Home Program Training/Exam rooms. This had the potential to negatively affect 35 incenter patients and seven Peritoneal Dialysis (PD) self-care patients who receive care at this facility. Findings include: Facility Procedure: 1-05-08A Title: Preparation of One to Ten (1:10) Bleach Solution Revision Date: October 2023 ...Procedure ...13. When the solution is not being used, place a lid on the bleach container...open to air causes the solution to degrade...becomes less effective... Facility Policy Number: 1-05-01 Title: Infection Control for Dialysis Facilities Revision Date: April 2023 Purpose: To minimize the spread of infections or blood borne pathogens in the dialysis facility environment. ...Disinfection 12...b. Use an appropriate disinfectant...bleach solution for routine disinfection of environmental surfaces... ...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings ...and frequently contacted by healthcare personnel ...front and sides of the dialysis machine...countertops... 14. Non-disposable items are to be disinfected after each patient use... Peritoneal Dialysis Policies & Procedures Title: Infection Control for Dialysis Policy: 5-06-01 Revision Date: April 2023 ...Disinfection ...13. At the end of each treatment, the dialysis station/training will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops) ... 1. Observations conducted on the incenter treatment floor on 7/22/24 at 8:52 AM across from station 21 revealed the 1:10 bleach container lid was on the counter and was not covering the bleach solution. At 9:45 AM the bleach container remained not covered. Staff failed to ensure the bleach solution was covered per policy. An interview was conducted on 7/24/24 at 1:49 PM with Employee Identifier (EI) # 1, Facility Administrator, confirmed the bleach solution must remain covered. 2. During observations of care on 7/22/24 at 9:12 AM on the incenter treatment floor, the surveyor observed EI # 7, Certified Clinical Hemodialysis Technician (CCHT), clean and disinfect dialysis station 15. EI # 7 failed to remove the clamp from the intravenous pole and disinfect the clamp, failed to clean the wire basket on the side of the dialysis machine, and the counter around the station. An interview was conducted on 7/24/24 at 1:49 PM with EI # 1, who verified staff failed to follow the facility policy for cleaning and disinfecting the dialysis machine. 3. A tour of the connecting Home PD Program Training/Exam rooms on 7/22/24 at 12:10 PM revealed one bag of Dianeal 2.5 % (Peritoneal Dialysis solution) out of the package laying at the PD training station counter next to the Patient Treatment Chair, and a bag of golden yellow colored fluid in the clean sink. An interview was conducted on 7/23/24 at 11:10 AM with EI # 6, Home Program Registered Nurse, who confirmed a patient required care on 7/19/24 in the Home Training/Exam room. EI # 6 confirmed the home training PD station had not been disinfected after the treatment. An interview was conducted on 7/24/24 at 12:20 PM with EI # 3, Regional Home Manager, who confirmed staff failed to follow facility infection control policies.”

“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: 30952 Based on medical record review, facility policy, and interview, it was determined the facility failed to ensure all patients were offered the hepatitis B vaccine series. This affected Patient Identifier (PI) # 3, in one of one record review for newly admitted patients to the facility within the last 90 days. Findings include: Facility Policy: Hepatitis Surveillance, Vaccination, and Isolation Guidance Policy: 1-05-02 Revision date: October 2021 Purpose: To minimize the spread of hepatitis infections in the dialysis setting. ...Policy: ...Admission Screening ...8. All...patients...will have HBV (hepatitis B virus) ...testing drawn immediately upon admission...and result known within seven days of admission... Admission Screening... ...Antibody < (less than) 10, Status Susceptible...Offer vaccination series... Hepatitis B Vaccination ...10. An order will be obtained for hepatitis B vaccination...The patient will consent to the vaccination or will decline. The completed form will be kept in the patient’s electronic health record ... 1. PI # 3 was admitted to the facility on 6/7/24 with a primary diagnosis of End Stage Renal Disease. Review of the Patient Summary Report printed 7/22/24 included 5/22/24 and 6/7/24 laboratory hepatitis B test results that revealed PI # 3 was not immune and was susceptible to the hepatitis B virus. MR review revealed no patient consent, no declination/refusal for the Hepatitis B vaccination series, and no documentation the Hepatitis B vaccination had been initiated. An interview was conducted on 7/24/24 at 1:19 PM with Employee Identifier # 2, Manager of Clinical Services, who confirmed staff failed to follow the facility policy for Hepatitis B vaccination.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 30952 Based on the CDC (Centers for Disease Control and Prevention) Recommendations for Providers Regarding Injection Safety, facility policy and procedure, observations, and interviews, it was determined the facility failed to ensure staff: 1. Followed aseptic technique during IV (intravenous) medication preparation (med prep) in one of three observations for IV medication preparation. 2. Secured medications in the Peritoneal Dialysis (PD) Home Program Training Room per facility policy. This affected Patient Identifier (PI) # 8 and had the potential to negatively affect the 35 incenter patients who dialyze at the facility, and the seven PD self-care patients who receive services at the facility. Findings include: CDC Injection Safety Date 2/7/24. Safe Injection Checklist for Clinicians ...The following Injection Safety checklist...subset of items...can be found in the CDC Infection Prevention Checklist for Outpatient Settings: Minimum Expectations for Safe Care....appropriate for both inpatient and outpatient settings, should be used to systematically assess adherence of healthcare providers to safe injection practices. .... The rubber septum on a medication vial is disinfected with alcohol prior to piercing. Facility Procedure Title: Intradermal Tuberculin Skin Test (TST)-Purified Protein Derivative (PPD) Mantoux Testing Procedure: 1-06-01M Revision Date: October 2021 ...Notes...A vial of Tuberculin...which has been entered and in use for 30 days should be discarded... Facility Policy Title: Medication Policy Policy: 1-06-01 Revision Date: October 2022 ...PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications. Policy: ...11. All refrigerated medications...are to be locked at the close of each business day or if not under supervision by the licensed teammate... 13. All open...vials are stored according to the manufacturer’s directions... 21. An aseptic environment and aseptic technique...used when preparing medications... 29. Medications containing a preservative must be discarded 28 days after opening...unless the manufacturer specifies a different date ...Each vial is labeled with the initials of the person opening the vial and expiration date... 1. During observations on the incenter treatment floor on 7/22/24 at 9:45 AM, the surveyor observed two opened multidose vials of PPD, with hand written dates on the medication bottles, 5/20/24, and 6/19/24. The two multi dose vials (MDV) were opened greater than 30 days and available for patient use. An interview was conducted on 7/22/24 at 11:10 AM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed staff failed to discard the open PPD vials per the manufacturer’s guidelines. 2. During IV Venofer preparation, EI # 4, Incenter Registered Nurse, disinfected the rubber septum of vial, pierced the septum with a three cubic centimeter (cc) needle/syringe, withdrew medication into the syringe, then instilled the IV medication back into the medication vial. EI # 4 retrieved a five cc syringe, pierced the septum with the new needle/syringe and withdrew the Venofer. EI # 4 failed to disinfect the vial septum prior to the needle insertion. EI # 4 administered the IV Venofer on 7/22/24 at 11:05 AM to PI # 8 at station 9. An interview was conducted on 7/24/24 at 1:50 PM with EI # 1, who confirmed staff failed to follow aseptic technique and facility policy during IV Venofer preparation. 3. On 7/22/24 at 12:10 PM, the surveyor toured the PD Home Training/exam room. There were no staff, and no patients present in the Home Training Program Exam room/area. The surveyor observed the medication refrigerator containing multiple IV Mircera doses was not secured and left un-locked. An interview was conducted on 7/22/24 at 12:12 PM with EI # 1, who confirmed staff failed to lock the medication refrigerator when not in use to secure patient medications.”

“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: 30952 Based on observation, facility policy and procedure, and interview, it was determined the facility failed to ensure staff performed CVC (central venous catheter) exit site per policy. This affected Patient Identifier (PI) # 8, in one of two CVC exit site care and initiation of dialysis with a CVC and had the potential to affect all CVC patients who dialyze at the facility. Findings include: Facility Policy: Central Venous Catheter with Clearguard HD (Hemodialysis) Antimicrobial End Caps Procedure Procedure Number: 1-04-02B Revised Date: October 2023 Notes: ...Procedure ...4. Remove old dressing and discard. ...8...using aseptic technique, clean exit site with 2 % Chlorhexidine Gluconate/70 % Isopropyl Alcohol (Chloraprep) swab for a minimum of 30 seconds... 1. An observation was conducted on the incenter treatment floor on 7/22/24 at 10:55 AM at station 9 with Employee Identifier (EI) # 4, Registered Nurse (RN), to observe CVC exit site care and dialysis initiation on PI # 8. During CVC exit site care, EI # 4 cleaned the CVC exit site with a Chloraprep (Chlorhexidine-skin antiseptic) swab stick for 15 seconds, and not the minimum 30 seconds per policy. An interview was conducted on 7/24/24 at 1:49 PM with EI # 1, Facility Administrator, and EI # 2, Manager of Clinical Services, who confirmed staff failed to follow the facility procedure for CVC exit site care.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30952 Based on observations, review of the manufacturer’s directions for use (DFU), and interviews, it was determined the facility failed to ensure staff followed the Nipro bloodline manufacturer’s DFU during dialysis treatments by maintaining the arterial drip chamber (a pressure and air monitoring component of the dialysis bloodline tubing) fluid levels at the required fill level. This had the potential to negatively affect all 35 incenter hemodialysis (HD) patients who dialyze at the facility. Findings include: NIPRO Instructions for use...Nipro Set Blood Tubing Set ...General Warnings and Precautions ...10. Maintain drip chamber at 3/4 (75 %) full to help prevent drip chamber evacuation, causing possible air embolus... Dialysis Treatment Precautions: ...3... During dialysis treatment: ...b. Periodically check fluid level in drip chamber and adjust if required. 1. Observations conducted on the incenter HD treatment area on 7/22/24 revealed the following: At 8:50 AM, the arterial drip chamber fluid level was less than 50 % full at station 8. At 8:52 AM, the arterial drip chamber fluid level was less than 35 % full at station 10 and at 9:32 AM, the arterial drip chamber fluid level was less than 15 % full. At 9:33 AM, the arterial drip chamber fluid level was less than 50 % full at station 11. At 9:34 AM the arterial drip chamber fluid level was less than 50 % full at station 12. An interview was conducted on 7/22/24 at 9:34 AM, with Employee Identifier (EI) # 4, Incenter Registered Nurse, who confirmed the arterial fluid level at station 10. EI # 4 reported he/she did not know the arterial chamber was required to be at a specific fill line as was the venous chamber. Additional observations conducted on the incenter HD treatment area on 7/22/24 revealed the following: At 10:05 AM, the arterial drip chamber fluid level was less than 50% full at station 3. At 10:05 AM, the arterial drip chamber fluid level was less than 25% full at station 4. At 11:55 AM, the arterial drip chamber level was less than 50% full at station 9. At 11:56 AM, the arterial drip chamber fluid level was less than 50% full at station 12. At 3:12 PM, the arterial drip chamber fluid level was less than 50% full at station 3. An interview was conducted on 7/24/24 at 1:49 PM with EI # 2, Manager of Clinical Services, who confirmed staff failed to follow the manufacturer’s DFU for maintaining the arterial chamber level.”

“PA-MSW-PSYCHOSOCIAL NEEDS CFR(s): 494.80(a)(7) The patient’s comprehensive assessment must include, but is not limited to, the following: (7) Evaluation of psychosocial needs by a social worker. This Standard is not met as evidenced by: 30952 Based on review of facility Survey Data Worksheet, facility policy, medical record (MR) and interviews, the social worker failed to address the psychosocial needs for one of four unstable patient records. This affected Patient Identifier (PI) # 1 and had the potential to negatively affect all patients who dialyze at the facility. Findings include: Facility Policy Title: Patient Behavior Agreements, 30 Day Discharge, Involuntary Discharge or Involuntary Transfer Policy: 8-03-02 Revision Date: October 2023 Purpose: To provide guidance...When the facility is considering involuntary discharge, the patient is automatically designated “unstable”...The Interdisciplinary Team (IDT) must assess...with an intent to identify any potential action or plan...prevent the need to discharge or transfer the patient... Policy: ...Threatening Behavior/Behavior Agreements: ...5. If a patient’s behavior...is threatening...physically...notify...Medical Director...physician...Network... 6. In collaboration with the...Network....make a determination whether the patient...be...discharged...or placed on a Behavior Agreement... 1.. PI # 1 was admitted to the facility on 8/1/12 with a diagnosis of End Stage Renal Disease. Review of facility Survey Data Worksheet documentation revealed PI # 1 was deemed “unstable” for psychosocial reasons on 5/20/24. MR review revealed a Patient Note dated 4/12/24 revealed PI # 1 was asked by the Facility Administrator, Employee Identifier (EI) # 1 to leave the facility following an altercation with a staff member who alleged PI # 1 touched the staff in an inappropriate manner. Further record review revealed on 4/12/24 the facility contacted Network 8 and received a recommendation to initiate a Behavior Contract with PI # 1. MR review revealed an IDT meeting was conducted 4/15/24 with PI # 1 for review of the Behavior Agreement. The documentation revealed PI # 1 refused to sign the agreement and requested a facility transfer. Review of a Physician Provider Note dated 5/15/24 revealed PI # 1’s request to transfer was denied by the receiving facility. Review of the Patient Plan of Care (POC) documentation dated 5/20/24, 6/19/24, and 7/15/24 revealed PI # 1 was deemed unstable by the IDT. Review of the Psychosocial Assessments for the POC’s dated 5/20/24, 6/19/24, and 7/15/24 POC s’ revealed the following psychosocial assessment documentation: “patient displays effective coping skills and verbalized ability to follow treatment regimen for referred modality. Patient has adequate resources to meet psychosocial needs.” There was no social worker psychosocial documentation that addressed progress/deterioration, and interventions following the 4/17/24 IDT meeting to initiate the Behavior Contract. An interview was conducted on 7/24/24 at 1:37 PM with EI # 1 who confirmed there was no documentation to reflect PI # 1’s psychosocial progress/lack of progress since the Behavior Contract was initiated.”

“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: 30952 Based on review of CMS (Centers for Medicare and Medicaid) Dialysis Facility Report (DFR), medical record (MR) reviews, facility policy, and interviews, it was determined the facility failed to ensure staff: 1. Administered as needed (prn) Clonidine for diastolic blood pressure (BP) greater than 90 millimeters/mercury (mm/Hg). 2. Notified the physician the post weight was greater than 1 kg (kilogram) from Target Weight (TW). 3. Ensured the UFR (ultrafiltration rate, the ratio of fluid removed to dialysis treatment time) pull was not greater than 13/mL/kg/hr (milliliters per kilogram per hour), and notified the physician when the UFR was above 13 mL/kg/hr. 4. Offered extended and/or additional dialysis treatments to address fluid overload. This affected PI (Patient Identifier) # 2, PI # 1, two of four incenter record reviews and had the potential to negatively affect all 35 incenter patients who dialyze at the facility. Findings include: Facility Policy: CWOW (Clinic without Walls)-Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment Policy Number: 1-03-08 Date Revised: October 2021 Purpose: To obtain and document baseline and ongoing information... Policy: 1. Patient data will be obtained and documented... a. Data collection includes... ...ii. Measurement of Blood Pressure... iv. Patient weight... Pre-Treatment Data Collection/Assessment ...4. Any abnormal findings...outside of any patient specific physician ordered parameters...will be documented...immediately reported to...nurse... Intradialytic Data Collection/ Assessment ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT (Patient Care Technician), or licensed nurse includes: b. At a minimum, obtain and document the following: i. Blood pressure... 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately... 12. The licensed nurse notifies the physician... as needed of changes in patient status. 13. All findings, intervention and patient response will be documented in the patient’s MR. 14. Additional documentation includes... a. All medications... Post Treatment Data Collection/Assessment ...16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the...nurse... 17. Licensed nurse...determine if...notification of physician is necessary prior to discharge... Abnormal Findings ...the following are considered abnormal findings...documented in...MR. Within each...may be adjusted by a patient specific physician order should be reported... Fluid Status: ...Post-treatment: If patient is above or below 1 kg from the TW. Blood Pressure...: Pre dialysis: ...Diastolic greater than (>) or equal to 100 mm/Hg BP-Intradialytic (ID): Difference of 20 mm/Hg increase...from last ID BP... BP Post Treatment: ..diastolic BP > than 90 mm/Hg... 1. PI # 2 was admitted to the facility on 4/10/23 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Patient Summary Report (PSR) revealed in-center active medication orders for Clonidine 0.1 milligram (mg) oral every four hours as needed, start date 11/17/23. Review of the Treatment Details Report (TDR) dated 7/8/24 revealed treatment orders for TW 65.5 kg. The pre treatment weight (pre wt) was 70.0 kg, and the pre (treatment) BP 152/108. Further review of the 7/8/24 TDR revealed at 8:32 AM BP 139/94, at 9:32 AM BP 140/105, at 10:02 AM treatment termination BP 140/95, at 10:12 AM post treatment BP 145/99, and post wt. 66.7 kg, which is 2.2. kg greater than TW. There was no documentation Clonidine was offered and refused for diastolic BP greater than 90 and no documentation the post treatment weight was reported to the physician. Review of the TDR dated 7/10/24 revealed orders for TW 65.5 kg and a 4 hour dialysis treatment time. The pre treatment BP was 161/102, at treatment start 5:56 AM BP 147/108, at 7:31 AM BP 160/103, BP 137/93 at 8:02 AM, at 8:32 AM BP 145/91, BP 145/95 at 9:34 AM, at 10:02 AM treatment end BP 139/95. Further review of the 7/10/24 TDR revealed at 10:02 AM post treatment BP was 139/95. PI # 2 dialyzed ordered treatment time, and the actual UFR 14.5 mL/kg/hour. There was no documentation Clonidine was offered and refused for elevated diastolic BP greater than 90. There was no documentation extended and or additional treatments were offered to manage the UFR > 13 mL/kg/hr. Review of the TDR dated 7/12/24 revealed TW orders 65.5 kg, pre treatment BP 159/106, and pre treatment weight 71.2 kg. Further review of the 7/12/24 TDR revealed at treatment start 6:00 AM BP 148/106, at 6:02 AM BP 147/97, at 6:32 AM BP 113/95, at 7:01 AM BP 145/94, at 7:32 AM BP 143/91, at 8:32 AM BP 159/103, at 9:02 AM BP 154/104, at 9:32 AM BP 154/100. Further review of the 7/12/24 TDR revealed at 9:58 AM treatment end BP 171/112, and at 10:05 AM post treatment BP 171/100 and post treatment wt. 67.7, which was 2.2 kg greater than TW. There was no documentation Clonidine was offered and refused for elevated diastolic BP greater than 90 and no documentation the TW greater than 2 kg was reported to the physician. Review of the TDR dated 7/15/24 revealed orders for a 4 hour dialysis treatment, TW 65.5 kg, the pre treatment BP 172/91, and the pre wt. 72.5 kg. Further review of the 7/15/24 TDR revealed treatment start 6:04 AM, BP was 164/119, at 6:31 AM BP 157/103, at 7:01 AM BP 149/98, at 7:31 AM BP 151/108, at 8:01 AM BP 147/100, at 8:31 AM BP 146/98, at 9:31 AM BP 141/92. Further review of the TDR dated 7/15/24 revealed PI # 2 dialyzed ordered treatment time, the actual UFR 15.8 mL/kg/hour, post wt 67.7 kg, which was 2.2 kg greater than TW. There was no documentation the PCT notified the nurse from 6:31 AM until 9:31 AM of the elevated BP. There was no documentation Clonidine was offered and refused for elevated diastolic BP greater than 90 mm/Hg, and the post treatment weight greater than 2.2 kg was reported. There was no documentation extended or additional treatments were offered to manage the UFR greater than 13 mL/kg/hr. Review of the TDR dated 7/17/24 revealed TW orders for 65.5 kg, pre treatment BP 139/99, at 5:55 AM treatment start BP was 157/97. Further review of the 7/17/24 TDR revealed at 6:01 AM BP 152/102, at 6:31 AM BP 154/104, at 7:01 AM BP 188/113, at 7:03 AM BP 166/117, at 7:31 AM BP 157/111, at 8:02 AM BP 156/102, at 8:31 AM BP 157/106, at 8:59 AM treatment end BP 152/123. Further review of the 7/17/24 TDR revealed at 9:03 AM post treatment BP 158/106. PI # 2 dialyzed ordered treatment time and the actual UFR 17.9 mL/kg/hour. There was no documentation the PCT notified the nurse from 6:31 AM until 8:31 AM of the elevated BP. There was no documentation Clonidine was offered and refused for elevated diastolic BP greater than 90 mm/Hg. There was no documentation extended or additional treatments were offered to address manage the UFR greater than 13 mL/kg/hr. Review of the TDR dated 7/19/24 revealed TW orders 65.5 kg, pre treatment BP 149/107, and at 5:54 AM treatment start BP 153/116. Further review of the 7/19/24 TDR revealed at 6:02 AM BP 159/107, at 6:32 AM BP 145/99, at 7:02 AM BP 135/93, at 7:32 AM BP 139/91, at 8:02 AM BP 140/100, at 8:32 AM BP 138/96, at 9:02 AM BP 138/106, at 9:32 AM BP 138/107, at 10:02 AM treatment end BP 137/102, and at 10:10 AM post treatment BP 137/102. There was no documentation the PCT notified the nurse from 6:02 AM until 9:32 AM of the elevated BP. There was no documentation Clonidine was offered and refused for elevated diastolic BP greater than 90. An interview was conducted on 7/24/24 at 9:44 AM with Employee Identifier # 1, Facility Administrator, who confirmed there was no documentation staff followed physician orders for prn Clonidine administration and notified the physician with post treatment wt’s >1.0 kg above TW. There was no documentation extended or additional treatments were offered to manage the UFR rate greater than 13 mL/kg/hr and post treatment wt’s 2 kg above TW. 2. PI # 1 was admitted to the facility on 8/1/12 with a diagnosis of ESRD. Review of the PSR revealed active orders for dialysis treatments three times a week, 210 minutes total (3 hour 30 minutes), Max UF (maximum ultrafiltration) 17.5 mL/kg/hr. Review of the TDR dated 7/8/24 revealed the UFR was 15.5 mL/kg/hr, the TDR dated 7/12/24 UFR was 14.8 mL/kg/hr, the TDR dated 7/15/24 UFR was 14.6 mL/kg/hr, the TDR dated 7/19/24 UFR was 15.3 mL/kg/hr, and TDR dated 7/22/24 UFR was 14.2 mL/kg/hr. There was no documentation extended or additional treatments were offered to address the UFR rate greater than 13 mL/kg/hr. An interview was conducted on 7/24/24 at 1:37 PM with EI # 2, Manager of Clinical Services, who confirmed staff failed to document extended or additional treatments to address the UFR rate greater than 13 mL/kg/hr were offered.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 30952 Based on medical record (MR) and interview, it was determined the facility failed to ensure staff followed the physician’s order for Blood Flow Rate (BFR). This affected Patient Identifier (PI) # 2, PI # 3, PI # 1, three of four incenter MR reviews, and had the potential to affect all 35 incenter patients who dialyze at the facility. Findings include: 1. PI # 2 was admitted to the facility on 4/10/23 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Details Report (TDR) dated 7/8/24 included orders for BFR 350 and the BFR was 305 from 7:02 AM to 8:02 AM, 300 at 8:32 AM, and 285 from 9:02 AM to treatment end at 10:02 AM. There was no documentation why the BFR was not 350 as ordered. Review of the TDR dated 7/12/24 included orders for BFR 350 and the BFR was 300 from 6:32 AM to treatment end at 9:58 AM. There was no documentation why the BFR was not 350 as ordered. Review of the TDR dated 7/17/24 included orders for BFR 350 and the BFR was 325 from 6:31 AM to 8:31 AM, then decreased to 200 at 8:59 AM, treatment end. There was no documentation why the BFR was not 350 as ordered. Review of the TDR dated 7/19/24 included orders for BFR 350 and the BFR was 325 at 6:02 AM, BFR decreased to 300 from 6:32 AM to 8:02 AM, decreased to 280 from 8:32 AM to 9:32 AM, and decreased to 260 at treatment end at 10:01 AM. There was no documentation why the BFR was not 350 as ordered. An interview was conducted on 7/24/24 at 1:24 PM with Employee Identifier (EI) # 2, Manager of Clinical Services, who confirmed staff failed to follow physician’s orders for BFR. 2. PI # 3 was admitted to the facility on 6/7/24 with a diagnosis of ESRD. Review of the TDR dated 7/17/24 included orders for BFR 400 and the BFR was 350 from 1:33 PM to treatment termination at 3:49 PM. There was no documentation why the BFR was not 400 as ordered. Review of the TDR dated 7/19/24 included orders for BFR 400 and the BFR was 345 from 1:32 PM to treatment termination at 3:49 PM. There was no documentation why the BFR was not 400 as ordered. An interview was conducted on 7/24/24 at 1:19 PM with EI # 2, who confirmed staff failed to follow physician’s orders for BFR. 3. PI # 1 was admitted to the facility on 8/1/12 with a diagnosis of ESRD. Review of the TDR dated 7/17/24 included orders for BFR 450 and the BFR was 400 from 8:31 AM to treatment end at 9:44 AM. There was no documentation why the BFR was not 400 as ordered. An interview was conducted on 7/24/24 at 1:37 PM with EI # 2, who confirmed staff failed to follow physician orders for BFR.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 30952 Based on medical record (MR) review, facility policy, and interviews, it was determined the facility failed to ensure Peritoneal Dialysis (PD) staff monitored the accuracy and completeness of the PD (treatment for kidney failure that uses the lining of your abdomen, or belly, to filter your blood inside your body) Clinical Data Report and provided education after patient treatment data review. This affected one of one PD self-care patient MR reviews, Patient Identifier (PI) # 4, and had the potential to negatively affect the seven PD patients treated at the facility. Findings include: PD Policies and Procedures Title: Daily Home Treatment Record (Flowsheet) Policy: 5-01-29 Revision Date: September 2023 Purpose: To provide guidance for proper documentation of home PD treatments...collect data to assist in assessing...patient’s response to PD treatments. To provide...acceptable daily home treatment record... Definitions: ...4. Connected Cycler-device that electronically captures...patient’s treatment data... Policy: ...3. As clinically applicable, all treatment data...must be collected.... reviewed to assist in evaluating...patient’s progress and self-care decision-making process. The post-treatment data review will be verified by the PD Registered Nurse (RN) documenting review in the MR per guidance below: ...b) If abnormal finding (s) or concern identified... c) The RN will use ...judgement... to determine...notification of physician...is necessary. ...Abnormal Findings ...the following are considered abnormal findings and should be reported...and documented in the patient’s MR... may be adjusted by a patient specific physician order...report ANY changes in patient conditions or concerns...immediately to the RN, and Nephrologist, as applicable. Fluid Status: If patient is above or below 2 kg (kilogram) from the target weight (TW) ...Heart or Pulse Rate Pre/Intra/Post: Less than (<) 60 beats per minute or greater than (>) 100 beats per minute... Temperature Pre/Post/Prn (as needed): Greater than 100 Degrees F (Fahrenheit) or 2 (two) degree rise over baseline. ...5. The...nurse is responsible for reviewing the...reports and noting discrepancies within the patient’s medical record: a. Sharesource-Prescribed vs (versus) Actual Report ...6. When a patient submits their treatment electronically...nurse...will be responsible for reviewing the data...Based on what the patient submits...follow up may be necessary and... electronic health record...updated to reflect any new information obtained. 1. PI # 4 was admitted on 8/7/23 for home PD services with diagnoses including End Stage Renal Disease. Review of the Patient Summary Report revealed CCPD (continuous cycler PD-an automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing PD dialysis) Treatment Order dated 5/18/24 with target weight (TW) 58 kg, use PD catheter for daily (Monday-Sunday) five exchanges via cycler, fill instructions for PD solution strength vary (dialysis solution comes in three different strengths: 1.5% dextrose ·2.5% dextrose - 4.25% dextrose) based on fluid status. Review of the Amia (American Medical Informatics Association) Patient Clinical Data Report Treatment Data (PCDTR) documentation dated 5/14/24 to 5/31/24 revealed no pre and post treatment temperatures. There was no documentation of the strength of the PD solutions administered 5/14/24 to 5/31/24. Further MR review revealed no weight (wt) change (variation) in pre and post treatment wts, wt greater than 2 kg above 58 kg TW, “skipped”/missing wts, pre and/or post treatment pulses < 60 beats per minute, and missing clinical data on the following dates: 5/14/24-60 kg pre wt and post wt (no variance) 5/15/24-90 kg (> 2 kg above TW) pre wt, “’skipped” post wt, pre pulse 59 (< 60) 5/16/24 post pulse 102 (greater than 100) 5/18/24-“skipped” post wt 5/19/24-pre wt 62.0 kg, post wt 62.0 kg-no variance and > 2 kg above TW 5/20/24-pre and post wt 62.0 kg no variance and > 2 kg above TW; pre pulse 52 (< than 60) 5/21/24 post pulse 57 5/22/24 pre and post wt 64.2 kg; pre pulse 54; post pulse 50 5/23/24 pre and post wt 64.2 kg 5/24/24 pre and post wt 64.0 kg; pre and post pulse 55 5/25/23 pre and post wt 64.0 kg; pre pulse 59, post pulse 55 5/26/24 pre and post wt 64.0 kg; post pulse 57 5/27/24 pre pulse 54 5/28/24-no Patient Clinical Data Report was documented this date. 5/29/24 pre and post wt 63.0 5/30/24 pre and post wt 63.0 kg; pre pulse 59 5/31/24 pre and post wt 63.0 kg Further review of the May 2024 Amia PCDR revealed Employee Identifier (EI) # 6, Home Program RN reviewed and signed the May 2024 Clinical Data Report on June 1, 2024. There was no documentation for pre and post temperatures, numerous pre and post treatment wts with no variance (change), missed post wts, the 5/28/24 missed PD treatment (no reason was documented), and pre and post pulses < 60, > 100 were addressed by the Home Program staff. There was no education on the incomplete, and potential inaccurate clinical data, and abnormal findings documented in the MR. Review of the Amia PCDTR documentation dated 6/1/24 to 6/30/24 revealed no pre and post treatment temperatures and no documentation of the strength of the PD solution strengths administered 6/1/24 to 6/30/24. Further MR review revealed no wt change in numerous pre and post treatment wt, wt greater than 2 kg above TW 58 kg and pre and/or post treatment pulses <60 on the following dates: 6/1/24-67.1 kg pre and post wt 6/3/24-67.0 kg pre and post wt, pre pulse 57 6/4/24-67.0 kg pre and post wt 6/5/24-67.0 kg pre and post wt 6/6/24-67.0 kg pre and post wt 6/7/24-67.0 kg pre and post wt, post pulse 59 6/8/24-67.0 kg pre and post wt 6/9/24-67.0 kg pre and post wt, post pulse 57 6/10/24-67.0 kg pre and post wt, post pulse 58 6/11/24-67.0 kg pre and post wt, post pulse 59 6/12/24-67.0 kg pre and post wt, post pulse 59 6/13/24-67.0 kg pre and post wt, post pulse 58 6/14/24-67.0 kg pre and post wt, pre pulse 52 6/15/24-67.0 kg pre and post wt, post pulse 56 6/16/24-67.0 kg pre and post wt, post pulse 58 6/17/24-67.0 kg pre and post wt 6/18/24-67.0 kg pre and post wt 6/19/24-67.0 kg pre and post wt 6/20/24-67.0 kg pre and post wt, post pulse 57 6/21/24-66.0 kg pre and post wt, post pulse 56 6/22/24-66.0 kg pre and post wt, post pulse 57 6/23/24-66.0 kg pre and post wt, post pulse 58 6/24/24-66.0 kg pre and post wt, pre pulse 57, post pulse 52 6/25/24-66.0 kg pre and post wt, pre pulse 58, post pulse 53 6/26/24-post pulse 58 6/27/24-63.5 kg pre and post wt, pre pulse 53 6/28/24-63.5 kg pre and post wt, post pulse 57 6/29/24-63.5 kg pre and post wt 6/30/24-63.5 kg pre and post wt Further review of the June 2024 Amia CPDR revealed the home treatment data was reviewed on 7/1/24 by the Home Training RN. There was no documentation wts greater than 2 kg TW, and pre and post pulses < 60 were reported to physician. There was no documentation education on completion of treatment pre/post temperatures, and Dianeal solution strength was performed. An interview was conducted on 7/23/24 at 10:15 AM with EI # 6, Home Training Program, RN, who reported he/she conducted daily reviews of the PD treatment Share Source Data (electronic), with findings discussed during clinic visits and documented in the MR. EI # 6 confirmed the missing pre and post temperatures, Dianeal PD solution strength, numerous pre and post treatment wts with no variance, and pulse rates < 60 were not addressed with education. EI # 6 confirmed there was no documentation abnormal weights and pulses were reported. An interview was conducted on 7/24/24 at 12:20 PM with EI # 3, Region Home Manager, who confirmed the PD Daily Treatment record documentation was incomplete, inaccurate, and included abnormal findings not documented as discussed with patient/caregiver, and physician.”