Davita Brookwood Dialysis Center

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 45999 Based on a review of policy and procedure, observation, and staff interview, it was determined that the facility failed to ensure: Staff appropriately cleansed (2) of (2) patients (Patients #1 and #3) vascular access prior to cannulation with fistula needles. Failure to practice appropriate safe aseptic technique when cleansing and disinfecting a patient’s vascular access increases the risk for vascular access and bloodstream infection if bacteria are not sufficiently reduced at the cannulation sites prior to needle insertion. Findings include: The policy titled “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose” requires: “...Check for patient sensitivity to preferred skin antiseptic/skin disinfectant listed in the table below (povidone iodine, hypochlorite ExSept Plus). Use Isopropyl Alcohol 70% as the single skin antiseptic ONLY when the patient has documented allergies to other skin antiseptics...Isopropyl Alcohol 70%...At least 4 prep pads per site...Effective Contact Time...60 seconds ...Povidone Iodine ...At least 1 prep pad per site or 1 saturated sterile gauze pad per site ...effective contact time 30 seconds per site and air-drying time of 2 minutes ...4. Prior to auscultating a bruit with a stethoscope ...16. Remove gloves perform hand hygiene and put on clean gloves prior to cannulation ....” Patient #1 Observation on 10/07/2024 revealed Employee #2 cleansing and disinfecting Patient #1’s vascular access in preparation of cannulation. Employee #2 used povidone-iodine prep pads. Employee # 2 cleaned the arterial site for 37 seconds and the venous cannulation site for 9 seconds. Patient #3 Observation on 10/07/2024 revealed Employee #4 cleansing and disinfecting Patient #3’s vascular access in preparation for cannulation. Employee #4 donned gloves after performing hand hygiene. Employee #4 then palpitated the access but never listened with a stethoscope and proceeded to clean the access in preparation for cannulation. Prior to cannulation, Employee #4 never changed gloves. Employee #1 confirmed on 10/09/2024, That Employee #2 and #4 did not follow facility policies and procedures for preparation of cannulating vascular access.”

“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: 45999 Based on a review of policy and procedure, observation, and staff interview, it was determined that the facility failed to ensure: Staff aseptically performed central venous catheter (CVC) care and dressing change for (1) of (1) patients (Patient #2). Failure to aseptically perform catheter care and a dressing change increases a patient’s risk of a CVC and/or bloodstream infection. Findings include: The facility policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” requires: “... Perform hand hygiene ...Provide a mask to the patient ...The teammate will wear a mask covering the nose and mouth during this procedure ...Set up clean field with all appropriate supplies on a clean, moisture-proof barrier...Verify patient’s clothing is secured away from the exit site/work area. Place the second moisture-proof barrier under the catheter limbs...Remove old dressing and discard...clean exit site with a 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery using both sides of the swab... Clean each CVC limb/cap with a new LARGE alcohol prep pad, starting close to the exit site and finishing with the cap...Holding the catheter with non-dominant hand, use other hand to place sterile 4x4 gauze under catheter limbs...Attach 10 ml syringes to the arterial and venous limbs....” Patient #2 Observation on 10/07/2024, revealed Employee #3 performing CVC care for Patient #2 as follows. Employee #3 lifted the patient’s tee shirt away from the CVC exit site but did not secure it. A moisture-proof barrier was then placed under the catheter limbs, Employee #3 then removed the previous dressing from the exit site and proceeded to clean the area with a 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab. Once Employee #3 was finished with the appropriate cleaning of the exit site, they proceeded to clean the catheter hubs. While cleaning the hubs of the catheter patient #2’s tee shirt fell over the exposed catheter exit site. Employee #3 lifted the tee shirt and proceeded to cover the exit site with gauze and tape however, Employee #3 did not clean the area again after being contaminated by the tee shirt. Employee #3 used the same pair of gloves from the beginning of the process until they connected patient #2 to the machine. Employee #1 confirmed on 10/09/2024, that staff did not perform CVC care as required by facility policy and procedure.”

“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: 49430 Based on review of facility policies and procedures, observations and staff interviews, it was determined that the facility failed to require staff dispose of expired supplies and medications, which has the potential risk of infection by using outdated items that may have lost their intended effectiveness for patients receiving hemodialysis treatments. Findings include: Facility policy, “Expiration Dates of Sterile Supplies” revealed: “...Sterile items will be checked before use to ensure that they have not expired...Appropriately dispose of sterile items that have reached the expiration date...” Observation on 10/07/2024 revealed the following expired supplies were found in the patient care area: 1- E-Z CHEK resudual chlorine test strips- Expired 2024-08-31 2- Suture Removal Kit- Expired 2024-03-30 3- MINNCARE HD redisule test strips- Expired 2024-09-22 Employee #1 confirmed the expiration dates of supplies and that policy was not followed in the removal and disposal of these items.”

“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: 49430 Based on review of policy and procedure, observation, staff interviews, and facility documents it was determined that the facility failed to ensure the building in which dialysis services are furnished be maintained to ensure the safety of the patients, the staff and the public. Policy titled “”PHYSICAL ENVIROMENT” requires “...2. The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates and the public....” Observation of the water room, conducted 10/07/2024, revealed the main floor drain protruding above the floor 2 inches. The concrete around the drain in a 6 to 8 inch diameter has sunken into the floor causing a depressed ring around the drain. Facility document titled “Work Order” revealed “Work Order Number WEB-522938...Date Reported: 3/20/2024 11:36:31 AM...Work Order Description...Floors in water tx room are cracked and need to be looked at....” Facility document titled “Work Order” revealed “Work Order Number WEB-581818...Date Reported: 10/07/2024 2:36:30 PM...Work Order Description...(Bio Med) called to report that the two floor drains in the RO room are cracked....” Interview with Employee #1 revealed the floor was reported for repair on 03/20/2024 and 10/07/2024. This deficit in the water room floor poses the risk for water accumulation, microorganism growth and tripping and falling hazard to staff.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 45999 Based on review of facility policy and procedure, medical records, and interview, the Department determined that the facility failed to ensure RNs and PCTs monitored, assessed, documented, and reported to the physician abnormal findings for (4) of (4) patients during treatment (Patients 4, 5, 6, and 7). This deficient practice limits the interdisciplinary team (IDT) in addressing blood pressure, heart rate, and fluid management issues in the patient’s plan of care if treatment data is not documented, assessed, and addressed in the patient’s medical record. Findings include: The facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” requires: “...Patient data will be obtained and documented...Data collection includes...Measurement of Blood Pressure...Intradialytic Data Collection/Assessment...Vital signs and treatment monitoring...At a minimum, obtain and document...Blood pressure...Abnormal findings...will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy) ...The assessment is a nursing responsibility...The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary ...The licensed nurse notifies the physician...as needed of changes in patient status...Abnormal Findings...Blood pressure: Pre-dialysis ...Systolic greater than 180 mm Hg ...Diastolic greater than or equal to 100 mm Hg ...Post Treatment ...Intradialytic blood pressures: Systolic greater than 180 mm/Hg or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg...Standing systolic BP greater than 140 mm Hg ...Standing diastolic BP greater than 90 mm Hg ...Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute....” Review of Patient Treatment Sheets reveals: Patient #4; 09/20/2024 13:07 HR 101 13:32 BP 88/68 13:38 HR 101 13:58 BP 118/48 HR 104 14:22 HR 200 14:48 HR 107 15:12 HR 106 15:37 HR 106 16:02 HR 105 16:10 HR 105 There was no documentation of the RN being made aware of vital signs being out of range 09/23/2024 1334 BP 106/42 14:11BP 118/47 There was no documentation of the RN being made aware of vital signs being out of range 09/27/2024 09:09 HR 102 09:30 HR 102 09:55 HR 102 11:10 HR 101 There was no documentation of the RN being made aware of vital signs being out of range 09/30/2024 11:30 HR 104 11:55 BP 115/46 10/04/2024 13:25 BP 117/48 15:56 HR 107 16:20 HR 101 16:36 HR 103 There was no documentation of the RN being made aware of vital signs being out of range Patient # 5 09/23/2024 14:13 BP 156/110 There was no documentation of the RN being made aware of vital signs being out of range 09/30/2024 15:27 BP 89/75 There was no documentation of the RN being made aware of vital signs being out of range Patient # 6 10/01/2024 09:02 BP 152/106 09:53 HR 55 There was no documentation of the RN being made aware of vital signs being out of range 10/03/2024 10:09 BP 169/101 11:05 BP 170/103 There was no documentation of the RN being made aware of vital signs being out of range Patient #7 09/28/2024 09:18 HR 108 There was no documentation of the RN being made aware of vital signs being out of range 10/01/2024 12:51 BP 166/123 There was no documentation of the RN being made aware of vital signs being out of range 10/03/2024 14:49 HR 111 14:54 HR 106 15:19 HR 112 15:22 HR 112 15:59 HR 104 17:01 HR 112 There was no documentation of the RN being made aware of vital signs being out of range 09/26/2024 12:55 HR 109 13:17 HR 145 14:22 HR 106 14:32 HR 103 15:07 HR 102 15:49 HR 102 There was no documentation of the RN being made aware of vital signs being out of range In an interview on 10/09/2024, Employee #1 confirmed that PCTs did not notify RNs of abnormal vital signs as required by facility policy.”

“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: 45999 Based on a review of facility documents and staff interviews, the Department determined that the facility failed to ensure verification the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters. Failure to properly monitor and react increases the risk to patients through suboptimal/potentially dangerous hemodialysis treatments A policy titled “DAILY WATER TREATMENT SYSTEM MONITORING” revealed: ...” To verify the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters ...The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Treatment Log ...a separate entry of time and initials is provided for the end-of-day hardness testing ...A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits ...Upon satisfactory completion of the review the licensed nurse initials and signs the log form where indicated....” Upon review of the Facility’s Daily Water Treatment Log; 08/08/2024- Missing end-of-day hardness testing and initials 08/09/2024- Missing end-of-day hardness testing and initials 08/12/2024- Missing end-of-day hardness testing and initials 08/13/2024- Missing licensed nurse initials 08/14/2024- Missing end-of-day hardness testing and initials 08/24/2024- Missing licensed nurse initials 08/30/2024- Missing licensed nurse initials, Missing end-of-day hardness testing, and initials 09/03/2024- Missing end-of-day hardness testing and initials 09/05/2024- Missing licensed nurse initials 09/06/2024- Missing end-of-day hardness testing and initials 09/07/2024- Missing licensed nurse initials, Missing end-of-day hardness testing and initials 09/09/2024- Missing end-of-day hardness testing and initials 09/10/2024- Missing end-of-day hardness testing and initials 09/17/2024- Missing licensed nurse initials, Missing end-of-day hardness testing and initials 09/18/2024- Missing licensed nurse initials, Missing end-of-day hardness testing and initials 09/20/2024- Missing licensed nurse initials, Missing end-of-day hardness testing and initials 09/21/2024- Missing end-of-day hardness testing and initials 09/24/2024- Missing licensed nurse initials, Missing end-of-day hardness testing and initials 09/27/2024- Missing end-of-day hardness testing and initials 09/28/2024- Missing teammate initials, Missing end-of-day hardness testing and initials 10/01/2024- Missing licensed nurse initials 10/02/2024- Missing teammate initials 10/04/2024- Missing end-of-day hardness testing and initials 10/05/2024-Missing licensed nurse initials, missing end-of-day hardness testing and initials The Daily Water Treatment Log was missing dates on the following days; 08/06/2024 08/07/2024 08/08/2024 08/09/2024 08/10/2024 08/16/2024 08/24/2024 08/27/2024 08/28/2024 08/29/2024 09/02/2024 09/03/2024 09/04/2024 09/06/2024 09/07/2024 09/09/2024 09/10/2024 09/11/2024 09/12/2024 09/13/2024 09/17/2024 09/18/2024 09/19/2024 09/20/2024 09/21/2024 09/23/2024 09/24/2024 09/25/2024 09/26/2024 09/27/2024 09/30/2024 10/01/2024 10/03/2024 10/04/2024 10/05/2024 10/07/2024 The Routine Total Chlorine Testing Log was missing Licensed nurse signatures on the following days: 08/08/2024 08/09/2024 09/06/2024 09/17/2024 Missing verification of RO running for 15 minutes and the licensed nurse signature 09/20/2024 Employee #1, confirmed in an interview conducted on 10/09/2024, that staff did not document as required per facility procedure.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure (4) of (6) dialysis technicians wore their mask correctly which has the potential risk of increased infection for patients if staff do not cover both their nose and mouth with a mask meant to minimize patient exposure to pathogens. The facility policy titled “Infection Control Quick Reference Guide” requires: “ ...Don PPE correctly ....” Observation on 02/08/2024 revealed Employees # 10, 11, 12, and 13 wearing a face mask inappropriately for the duration of observation on the treatment floor from 0805 to 0910. Employee #10, 12 and 13 wore their mask underneath their nose while providing patient care at multiple stations. Employee #11 was observed wearing his/her mask below his/her chin while taking a patient off of treatment at Station #16. Employee #11 adjusted his/her mask from below the chin to just under his/her nose for the duration of observation. Employee #1 confirmed on 02/08/2024 that staff are required to wear a face mask when providing patient care and that the observed staff did not wear their masks appropriately as required.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 37489 Based on review of documents, observation, and staff interview, it was determined the facility failed to ensure: (V111) staff maintained a clean and sanitary environment which has the potential risk of harm to patients due to a cluttered environment and potential exposure to contaminated sharps and supplies. (V112) staff aseptically maintained vascular access prior to disconnection of fistula needles. Failure to practice safe aseptic technique when cleansing and disinfecting a patient’s vascular access and use clean supplies for securing needles and ports increases the risk for vascular access and blood stream infection. (V113) 1. direct care staff did not have artificial nails while providing patient care. Failure to follow established standard and infection control precautions poses an increased risk of infections for immunocompromised patients through contact transmission and cross contamination; and 2. staff encouraged patients to wash their vascular access prior to treatment and wash their hands after termination of dialysis and holding access sites which has the potential risk of increased infection to patients through contact transmission and cross contamination; and 3. staff did not perform hand hygiene after touching biohazard and before touching clean surfaces and when escorting a patient to the treatment floor which has the potential risk of infection through cross contamination. (V116) staff did not store a cleaned stethoscope in a dirty area after use which has the potential for cross contamination and increased infection. (V122) staff cleaned, disinfected, and discarded and/or disinfected supplies used at the dialysis station which has the potential risk of infection to patients through cross contamination and contact transmission. (V130) staff appropriately wore and changed PPE when entering and exiting the Isolation room which has the potential risk of infection through cross contamination of Hepatitis B to susceptible patients. (V143) staff appropriately labeled multi-dose medication vials when opened. (V147) staff aseptically performed CVC (central venous catheter) dressing change/catheter care prior to initiation of treatment. Failure to perform CVC dressing change and catheter care correctly poses a potential risk for increased CVC and/or bloodstream infection and adverse outcomes for dialysis patients. The ESRD facility failed to be in compliance with the Condition for Coverage for Infection Control. Failure to implement and sustain acceptable infection control practices increases the potential risk of patient-to-patient and staff-to-patient transmission of infectious agents, whether directly or indirectly.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 37489 Based on review of facility documents, policy/procedure, Association for the Advancement of Medical Instrumentation (AAMI) standards and manufacturer’s guidelines, observation, and staff interview, it was determined the facility failed to ensure: (V177) to demonstrate compliance with chemical analysis of product and source water used in the preparation of dialysate and concentrates used for patient treatment which has the potential risk of patient harm from unsafe source and/or product water used for dialysis treatment. (V252) to demonstrate compliance with monthly water samples for microbial monitoring water used for patient treatment which has the potential risk of patient harm from contaminated water used for dialysis treatment. (V253) to demonstrate compliance with monthly samples for microbial monitoring of dialysate which has the potential risk of patient harm from contaminated dialysate used for dialysis treatment. (V260) (1) of (1) staff were aware of correct patient take off procedures in the clinic in the event of a chlorine breakthrough which has the potential risk of harm or death for patients on dialysis treatment if staff do not implement the appropriate interventions The ESRD facility failed to be in compliance with the Condition for Water and dialysate quality. Failure to implement and sustain acceptable water treatment and dialysate preparation practices poses a significant risk to patients for serious life-threatening events during patients’ treatments.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 49430 Based on observation and interview, the Department determined that the administrator failed to ensure staff maintained a clean and sanitary environment which has the potential risk of harm to patients due to a cluttered environment and potential exposure to contaminated sharps and supplies. Findings include: Observation on 11/27/2023 revealed generalized debris and supplies on the treatment floor around all 24 dialysis stations as follows. Stations 1/2 - dialyzer caps, paper wrappers, a syringe, fistula needle caps, and spilled bicarb Stations 3/4 - fistula needle caps Stations 5/6 - a piece of gauze and a torn dressing wrapper Stations 7/8 - plastic overwrap from supplies, CVC end caps, a syringe, and saline syringe caps Stations 9/10 - supply wrappers, paper wrappers Stations 11/12 - paper wrappers, and dialyzer caps Stations 13/14 - spilled bicarb, trash overflowing and on floor Stations 15/16 - spilled bicarb, a roll of paper tape, syringe caps Stations 17/18 - spilled bicarb, saline syringe cap, needle caps Stations 21/22 - syringe caps, paper wrappers Isolation - an open exposed needle, needle caps, wrappers Isolation - dialysis chair with cracks/tears in covering Observation on 11/28/2023 revealed two partially filled sharps containers filled with used vacutainers and butterfly needle sets under a sink cabinet in the conference room. Also stored in the under-sink cabinet were disposable drinking cups, a dispenser container of sugar, a roll of Reynolds wrap foil, dialysis supplies marked “training”, a flower vase, paper goods, and decorations. A side cabinet contained laboratory supplies and equipment. Employee #2 confirmed on 11/27/2023 that the facility was not maintained in a sanitary manner are required by policy.”

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 49430 Based on review of policy/procedure, observation, and staff interview, it was determined that the facility failed to ensure staff aseptically maintained vascular access prior to disconnection of fistula needles. Failure to practice safe aseptic technique when cleansing and disinfecting a patient’s vascular access and use clean supplies for securing needles and ports increases the risk for vascular access and blood stream infection. Findings include: The facility policy titled “Termination of Dialysis utilizing B Braun Dialog+Dialysis Delivery Systems with all Single use Dialyzer Types and Streamline Blood Lines” requires: “...12. Clamp venous blood line and venous access line. 13. Check patient’s blood pressure (BP). If stable, press cancel to exit reinfusion screen. If hypotensive, restore BP by infusing additional saline. 14. Disconnect venous blood line from the venous access.....” Observation on 11/28/2023 revealed Patient Care Technicians (PCT), at stations #7, 12 and 21, were disconnecting both the arterial and venous blood lines, allowing the fistula needle ports to be clamped and not securing the ends with any device, leaving the open ports open to air and dangling from the patient’s arm, standing the patient for a standing blood pressure, then reseating the patient and then removing fistula needles. T Employee #2 confirmed witnessing the same practice on 11/28/2023 and that the practice of allowing up capped fistula needles to hang from the patients arm while PCT takes a standing BP is not per the facilities policy.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure: 1. direct care staff did not have artificial nails while providing patient care. Failure to follow established standard and infection control precautions poses an increased risk of infections for immunocompromised patients through contact transmission and cross contamination; and 2. staff encouraged patients to wash their vascular access prior to treatment and wash their hands after termination of dialysis and holding access sites which has the potential risk of increased infection to patients through contact transmission and cross contamination; and 3. staff did not perform hand hygiene after touching biohazard and before touching clean surfaces and when escorting a patient to the treatment floor which has the potential risk of infection through cross contamination. Findings include: 1. The facility policy titled “Infection Control for Dialysis Facilities” requires: “...It is a requirement for all DaVita teammates whose primary location is working in a facility to have only natural nails and fingernail length should not extend more than 1/4 inch. Traditional nail polish that is not chipped may be worn....” The facility document titled “Infection Control Quick Reference Guide” requires: “...Fingernails...Artificial fingernails, nail extenders or nail enhancements ‘including but not limited to nail jewelry, sculptor, acrylic or resin overlays or bonding, gels, tips, wraps, hybrid gels’ are not permitted....” The CDC “Morbidity and Mortality Weekly Report, October 25, 2002 / Vol. 51 / No. RR-16, Guideline for Hand Hygiene in Health-Care Settings Recommendations” revealed: “...HCWs who wear artificial nails are more likely to harbor gram-negative pathogens on their fingertips than are those who have natural nails, both before and after handwashing...Personnel wearing artificial nails also have been epidemiologically implicated in several other outbreaks of infection caused by gram-negative bacilli and yeast...These recommendations are designed to improve hand hygiene practices of HCWs and to reduce transmission of pathogenic microorganisms to patients and personnel in healthcare settings...Do not wear artificial fingernails or extenders when having direct contact with patients at high risk....” Observation on 11/27/2023 and 11/28/2023 revealed Employee #32 providing patient care services in the treatment area for patients on dialysis while wearing artificial nails. Employee #32 confirmed in an interview on 11/28/2023 that s/he wore artificial nails while providing patient care despite the facility policy prohibiting the wearing of artificial nails while providing direct patient care. 2. The policy titled “Infection Control for Dialysis Facilities” requires: “...Hand Hygiene...Patients and caregivers will be encouraged to wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis...Perform hand hygiene after treatment before leaving the treatment area....” Observation on 11/28/2023 revealed (5) of (5) patients entering the treatment floor for dialysis and not asked or told to wash their vascular access prior to cannulation by staff or assisted by staff if the patient was unable to perform their own access wash. Observation on 11/28/2023 revealed (4) of (5) patients exit the treatment floor after dialysis without performing hand hygiene. Employee #2 and 3 confirmed on 11/28/2023 that staff did not follow facility policy for encouraging and/or assisting patients with washing their vascular access upon entering the treatment floor and cannulating the patients. Additionally, that staff did not encourage patients to wash their hands after dialysis before leaving the treatment areas. 3. The facility policy titled “Infection Control for Dialysis Facilities” requires: “...Hand Hygiene...All teammates, Physicians and Non-Physician (NNP) will perform hand hygiene...after contamination with blood or other infectious material...before touching clean areas such as supplies, supply cart and chairside keyboard/mouse....” Observation on 11/28/2023 revealed Employee #20 leave a dialysis station after setting up the machine, walk to a large biohazard bin, removed his/her gloves, lift off the removable lid with bare hands, and deposit the dirty gloves. Hand hygiene was not performed, the staff member walked to the treatment/lobby door, opened the door by the handle with dirty hands, and escorted a patient back to a dialysis station without performing hand hygiene and donning clean gloves. Observation on 11/28/2023 revealed Employee #32 moved a large biohazard bin across the treatment floor with gloved hands, then walked to a patient machine, and touched the machine with the dirty gloves to silence a machine alarm. Employee #2 confirmed on 11/28/2023 that staff did not perform hand hygiene as required by facility policy.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff did not store a cleaned stethoscope in a dirty area after use which has the potential for cross contamination and increased infection. Findings include: The facility document titled “Infection Control Quick Reference Guide All Modalities” requires: “...Stethoscopes...Hang cleaned stethoscope either at the dialysis station or in a central clean location....” Observation on 11/28/2023 revealed Employee #13 retrieve from a dirty sink area and use a multiple use stethoscope to auscultate a patient’s vascular access. Employee #13 used an alcohol prep pad to disinfect the stethoscope and replaced the cleaned stethoscope back in the dirty sink area. Employee #2 confirmed on 11/28/2023 that cleaned and disinfected multiple patient use equipment was not stored in a clean area as required.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff cleaned, disinfected, and discarded and/or disinfected supplies used at the dialysis station which has the potential risk of infection to patients through cross contamination and contact transmission. Findings include: The policy titled “Infection Control for Dialysis Facilities” requires: “...Disinfection...Prior to routine disinfection, remove all visible blood...a 1:10 (one to ten) bleach solution must be utilized...Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces...using a wiping motion with friction. Sufficient disinfectant should be applied so that surfaces are visibly wet...Non-disposable items are to be disinfected after each patient use....” Observation on 11/27/2023 revealed (7) of (23) emergency take off bags at the dialysis stations were not zipped and appropriately cleaned after patient treatments. The bags contained disposable supplied and equipment visible from the opening of the bag and/or partially hanging out that were not discarded use. One dialysis take off bag was laying on the countertop behind the dialysis station and not hanging off the TV arm as were the other 23 and was not cleaned after the patient exited the station. Employee #2 confirmed on 11/27/2023 that the supplies in the take-off bags were contaminated and not discarded, nor were the bags appropriately disinfected after potential exposure to infectious agents as required by facility policy. Observation on 11/28/2023 revealed Employee #13 cleaning and disinfecting Station #13. Employee #13 did not disinfect the entire IV pole on the machine, the entire machine surface, the entire chair surfaces, and partially cleaned the TV arm. Employee #13 did not remove the hemostat hanging on the IV pole arms after the last patient left the station, left the dirty hemostat on the IV pole when setting up the machine with supplies for the next patient, and initiated treatment on the next patient before removing the dirty hemostats. Observation on 11/28/2023 revealed Employee #32 cleaning and disinfecting Station #21. Employee #21 did not disinfect the entire IV pole on the machine, the entire machine surface, the entire chair surfaces, and partially cleaned the TV arm and emergency take off bag. Observation on 11/28/2023 revealed residual dried blood spatter on (4) of (6) sharps containers. Employee #2 confirmed on 11/28/2023 that staff did not clean and disinfect the dialysis stations as required by facility policy. Observation on 11/28/2023 revealed visible blood more than an inch in diameter not cleaned off the floor at Station #6 after a patient’s treatment was completed and the station was set up and the next patient brought back to the station. Employee #2 confirmed on 11/28/2023 that the blood on the floor was not cleaned and the floor disinfected as required by policy.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff appropriately wore and changed PPE when entering and exiting the Isolation room which has the potential risk of infection through cross contamination of Hepatitis B to susceptible patients. Findings include: The policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” requires: “...PPE...When entering the isolation room/area or station for any reason, physicians, NPPs, social workers, dietitians, and all other teammates will wear long-sleeved fluid resistant/fluid impervious gowns in addition to gloves, face shield, or mask and eye protection...PPE will be removed, gloves discarded, and hand hygiene performed immediately when leaving the room or area....” Observation on 11/27/2023 revealed Employees #10 and 32 enter and exit the Isolation room wearing the same PPE without changing it, or removing it after exiting the room with a Hepatitis B patient dialyzing. Employees #2 and 3 confirmed that staff did not follow the facility hepatitis infection control policy of donning PPE to enter the isolation room, or removing the PPE and performing hand hygiene as required.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff appropriately labeled multi-dose medication vials when opened. Failure to label medication vials when opened with an appropriate expiration date prevents staff from knowing when to discard the vial which increases the risk a patient will receive a medication that is no longer stable, and that may be contaminated due to reduction of preservative efficacy as well as an increased exposure to pathogens from accessing a vial multiple times. Findings include: The facility policy titled “Medication Policy” requires: “...Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date or as directed by the manufacturer...Each vial is labeled with the initials of the person opening the vial and the expiration date....” The manufacturer’s directions for use for multidose Epogen requires: “...Do not store the vial for more than 21days....” Observation on 11/27/2023 revealed an open, multidose vial of Epogen labeled with an open date of 11/17/2023 and an expiration date of 12/14/2023. Employee #6 confirmed that s/he did not know the maximum timeframe that a vial of Epogen was good for before it was expired and should be discarded. S/he confirmed that the label on the vial indicated it had a 28-day open life span prior to expiration. Employee #5 confirmed that the open Epogen vial was mislabeled with an incorrect expiration date and should have been labeled with an expiration date 21 days after opening as required by manufacturers recommendation. Observation on 11/27/2023 revealed an open, in use multidose vial of Tubersol purified protein derivative. The vial was not labeled with an open or discard date. Employee #5 confirmed on 11/27/2023 that the open vial of Tubersol was not labeled as required by facility policy.”

“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: 37489 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure staff aseptically performed CVC (central venous catheter) dressing change/catheter care prior to initiation of treatment. Failure to perform CVC dressing change and catheter care correctly poses a potential risk for increased CVC and/or bloodstream infection and adverse outcomes for dialysis patients. Findings include: The facility policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” requires: “...Teammate and patient will wear masks covering the nose and mouth during this procedure...Set up clean field...on a moisture proof barrier...Place the second moisture proof barrier under catheter limbs...Remove old dressing and discard...clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab...apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery...Clean each CVC limb/cap...Place sterile 2x2 gauze over the exit site...Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood....” Observation on 11/27/2023 revealed Employee #32 performing CVC dressing change and catheter care. Employee #32 removed the old dressing, applied disinfectant appropriately then immediately cleaned the CVC limbs with isopropyl alcohol pads. Once the limbs were cleaned, Employee #32 scrubbed and removed each end cap from the limbs and left the hubs open while completing the dressing change. They hubs were left open during the dry time of the chlorhexidine disinfectant and application of the new dressing prior to attaching syringes and accessing the catheter. Employee #2 confirmed on 11/28/2023 that Employee #32 did not complete the dressing change procedure as required by policy before opening and exposing the catheter limb hubs. Observations on 11/28/2023 at chair #6 revealed an employee scrubbed the blue access port of a CVC for 6 seconds and then the red port for 6 seconds and allowed no dry time prior to attaching hemodialysis blood lines to ports of patient #15. Observations on 11/28/2023 at chair #7 revealed an employee scrubbed the blue access port of a CVC for 12 seconds and then the red port for 12 seconds and allowed no dry time prior to attaching hemodialysis blood lines to the ports of patient #16. Employee #1 confirmed on 11/29/2023, scrubbing ports less than 15 seconds and/or not allowing appropriate dry time is not within facility policy guidelines .”

“MAX LEVEL OF CHEM CONTAM H20/CHEM ANALYSIS CFR(s): 494.40(a) 4 Fluid quality 4.1 Water 4.1.1 Maximum level of chemical contaminants in water: chem analysis Product water used to prepare dialysate or concentrates from powder at a dialysis facility, or to process dialyzers for reuse, shall not contain chemical contaminants at concentrations in excess of those listed in ANSI/AAMI RD62, which is reproduced in Table 1 below: Table 1-Maximum allowable chemical contaminant levels in water used to prepare dialysate and concentrates from powder at a dialysis facility and to reprocess dialyzers for multiple uses (Reproduced from ANSI/AAMI RD62:2001) Contaminant / Maximum concentration (mg/L) Calcium 2 (0.1 mEq/L) Magnesium 4 (0.3 mEq/L) Potassium 8 (0.2 mEq/L) Sodium 70 (3.0 mEq/L) Antimony 0.006 Arsenic 0.005 Barium 0.10 Beryllium 0.0004 Cadmium 0.001 Chromium 0.014 Lead 0.005 Mercury 0.0002 Selenium 0.09 Silver 0.005 Aluminum 0.01 Chloramines 0.10 Free Chlorine 0.50 Copper 0.10 Fluoride 0.20 Nitrate (as N) 2.0 Sulfate 100 Thallium 0.002 Zinc 0.10 NOTE-American National Standards are revised every three to five years. Users should consult the most recent edition of ANSI/AAMI RD62 to ensure that the levels listed in this table are still valid. The manufacturer or supplier of a complete water treatment system should recommend a system that is capable of meeting the requirements of this clause at the time of installation given the analysis of the feed water. The system design should reflect possible seasonal variations in feed water quality. Following installation of a water treatment, storage, and distribution system, the user is responsible for continued monitoring of the levels of chemical contaminants in the water and for complying with the requirements of this standard. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to demonstrate compliance with chemical analysis of product and source water used in the preparation of dialysate and concentrates used for patient treatment which has the potential risk of patient harm from unsafe source and/or product water used for dialysis treatment. Findings include: Documentation of chemical analysis for water contaminates from both feed and product water used to make dialysate was requested on 11/27/2023 and 11/28/2023. No documentation was provided at the time of survey exit on 11/29/2023. Employee #27 confirmed in an interview on 11/28/2023 that the area is short staffed with biomedical staff, that the previous biomed left in the last few weeks, and that s/he did not have access to any records to demonstrate compliance with this regulation.”

“MICROB MONITOR-MO H20 SAMPLES/METHOD CFR(s): 494.40(a) 7.2 Microbial monitoring methods: monthly water samples/method 7.2.1 General Culture water ...weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Monitoring can be accomplished by direct plate counts, in conjunction with the measurement of bacterial endotoxin. 7.2.2 Sample collection Water samples should be collected directly from outlet taps situated in different parts of the water distribution system. In general, the sample taps should be opened and the water should be allowed to run for at least 60 seconds before a sample is collected in a sterile, endotoxin-free container. A minimum of 50 mL of water, or the volume specified by the laboratory performing the test, should be collected. Sample taps should not be disinfected. This Standard is not met as evidenced by: 49430 Based on document review and interview, it was determined that the facility failed to demonstrate compliance with monthly water samples for microbial monitoring water used for patient treatment which has the potential risk of patient harm from contaminated water used for dialysis treatment. Findings include: Documentation of microbial monitoring for water contaminates from water used to delivery dialysis treatment was requested on 11/27/2023 and 11/28/2023. No documentation was provided at the time of survey exit on 11/29/2023. Employee #27 confirmed in an interview on 11/28/2023 that the area is short staffed with biomedical staff, that the previous Biomed left in the last few weeks, and that s/he did not have access to any records to demonstrate compliance with this regulation.”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to demonstrate compliance with monthly samples for microbial monitoring of dialysate which has the potential risk of patient harm from contaminated dialysate used for dialysis treatment. Findings include: Documentation of microbial monitoring of dialysate used to delivery dialysis treatment was requested on 11/27/2023 and 11/28/2023. No documentation was provided at the time of survey exit on 11/29/2023. Employee #27 confirmed in an interview on 11/28/2023 that the area is short staffed with biomedical staff, that the previous Biomed left in the last few weeks, and that s/he did not have access to any records to demonstrate compliance with this regulation.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 37489 Based on observation, document review, and policy/procedure, it was determined that the facility failed to ensure (1) of (1) staff were aware of correct patient take off procedures in the clinic in the event of a chlorine breakthrough which has the potential risk of harm or death for patients on dialysis treatment if staff do not implement the appropriate interventions in the event of a chlorine breakthrough in the water room. Findings include: Observation on 11/29/2023 revealed Employee #13 performing a routine chlorine/chloramine test in the water room. Employee #13 was asked to verbalize steps to be taken in the event of a chorine breakthrough after performing the chlorine test. Employee #13 verbalized that if the secondary tank test result was less than or equal to 0.1 ppm that additional testing would be done every 15 minutes. Additionally, Employee #13 did not verbalize placing patients’ machines in bypass and not returning patients’ blood if the results of the secondary tank were greater than 0.1 ppm. The facility policy titled “Daily Water System Total Chlorine Monitoring” requires: “...Total Chlorine testing is done on a daily basis prior to the first patient treatment and within every four (4) hours until all activities that require use of dialysis quality water are completed...If the results of Total Chlorine testing from the primary carbon filter...indicate a level of less than or equal to 0.1 ppm...Record results...If the results...from the primary carbon filter indicate a level of greater than 0.1 ppm...the test should be immediately repeated on a freshly drawn sample to verify the results are not a ‘false positive.’...If the repeat results...is less than or equal to 0.1 ppm...no additional testing is needed...If the result of the repeat...testing is greater than 0.1 ppm...proceed immediately with the steps below...draw a sample...from the sample port located downstream of the second (secondary) carbon tank...If the results...indicate a level less than or equal to 0.1 ppm...dialysis treatments may be performed, but additional testing must be done every 30 minutes until the primary carbon filter(s) are services, re-bedded or replaced...If the results of testing from the secondary carbon filter...indicate a level greater than 0.1 ppm...the charge nurse must be immediately notified and dialysis treatments must be discontinued by placing dialysis delivery system into bypass, discontinue treatment and do not rinse patient’s blood back....” Employee #1 confirmed on 11/29/2023 that Employee #13 did not correctly verbalize appropriate chlorine breakthrough procedures according to facility policy.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure medications in the treatment area were locked and secured to prevent unauthorized access. Failure to secure medications when not in use may result in unauthorized access to medication not prescribed to an individual and the potential for tampering or other compromise to the integrity of medications administered. Findings Include: The facility policy titled “Medication Policy” requires: “...Non-refrigerated medications are to be stored in cabinets(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations....” Observation on 11/27/2023 revealed an unsupervised, unlocked drawer at the nurses’ station containing four (4) prefilled Mircera 30 mcg/0.3 ML IV syringes, two (2) single dose vials Venofer 20 mg/ML, one (1) predrawn syringe of Venofer 50 mg, and four (4) medicine cups with multiple Calcitriol capsules. Employee #5 confirmed on 11/27/2023 that the unsupervised medications were left unlocked and not secured as required by facility policy. Observation on 11/28/2023 revealed an unlocked, unsupervised medication lockbox at a PCT work station that contained a predrawn Heparin syringe for patient administration. Additional observation revealed an unlocked, unsupervised medication lockbox at a second PCT work station that contained five (5) predrawn Heparin syringes for patient administration. Employee #2 confirmed on 11/28/2023 that predrawn Heparin syringes found at two PCT work stations on the treatment floor were not locked and secured as required by facility policy.”

“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: 37489 Based on document review and interview, it was determined that the facility failed to demonstrate compliance with machine and ancillary equipment preventative maintenance which has the potential risk of damaged and/or non-calibrated equipment being used to provide treatments to dialysis patients. Findings include: Documentation of dialysis machine preventative maintenance and ancillary equipment maintenance was requested on 11/27/2023 and 11/28/2023. No documentation was provided at the time of survey exit on 11/29/2023. Employee #27 confirmed in an interview on 11/28/2023 that the area is short staffed with biomedical staff, that the previous Biomed left in the last few weeks, and that s/he did not have access to any records to demonstrate compliance with this regulation.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the administrator failed to ensure staff administered treatment medication for hypertension as ordered by the patient’s nephrologist for (1) of (1) patient (Patient #7) which has the potential risk to patients for adverse outcomes related to untreated hypertension. Findings include: The facility document “SKI/DaVita PRN Panel” requires: “...Medication...Clonidine...0.1 mg PO...0.10 mg for systolic BP (greater than or equal to) 180 and/or diastolic (greater than or equal to)110 after 60 minutes on treatment. May repeat X 1 after one hour if BP remains (greater than or equal to)180 and/or diastolic (greater than or equal to) 110....” Patient #7 11/20/2023 1350 Pretreatment BP 199/111, the RN documented “Elevated BP...will monitor” 1351 BP 210/120 1416 BP 223/112 1418 BP 228/120 1420 BP 227/113 1440 BP 240/120 1442 BP 236/116 1448 BP 235/116 1513 BP 246/107 1515 BP 223/111 1538 BP 239/111 1603 BP 245/109 1628 BP 242/120 1641 Post treatment BP 252/108, the RN documented “take...BP medications...when gets home” The treatment sheet did not contain any documentation of assessment by the RN, or notification to the physician pre, intra, or post treatment. The medical record clonidine was not administered as prescribed, nor was there any documentation the patient was offered and/or refused administration of antihypertensive medication. Employee #1 and 3 confirmed on 11/29/2023 that the RN did not administer medication for severe hypertension as prescribed by the patient’s nephrologist.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 49430 Based on review of facility policy and procedure, medical records, and interview it was determined that the facility failed to ensure RNs and PCTs monitored, assessed, and documented abnormal findings for (6) of (6) patients during treatment (Patients #2, 4, 5, 6, 7, and 8). This deficient practice limits the interdisciplinary team (IDT) in addressing blood pressure, heart rate, and fluid management issues in the patient’s plan of care if treatment data is not documented, assessed, and addressed in the patient’s medical record. Findings include: The facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” requires: “...Patient data will be obtained and documented...Data collection includes...Measurement of Blood Pressure...Intradialytic Data Collection/Assessment...Vital signs and treatment monitoring...At a minimum, obtain and document...Blood pressure...Abnormal findings...will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician...as needed of changes in patient status...Abnormal Findings...Blood pressure: Pre-dialysis ...Systolic greater than 180 mm Hg ...Diastolic greater than or equal to 100 mm Hg ...Blood Pressure-Intradialytic...Difference of 20 mm/Hg increase or decrease from patient’s last intradialytic treatment BP reading ...Post Treatment ...Standing systolic BP greater than 140 mm Hg ...Standing diastolic BP greater than 90 mm Hg ...Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute....” Review of Patient Treatment Sheets reveals: Patient #2; 10/27/2023 1314 HR 50, No RN notification for bradycardia, or RN assessment and follow up 1330 HR 51, No RN notification for bradycardia, or RN assessment and follow up 1355 HR 52, No RN notification for bradycardia, or RN assessment and follow up 1420 HR 50, No RN notification for bradycardia, or RN assessment and follow up 1436 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1445 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1511 HR 50, No RN notification for bradycardia, or RN assessment and follow up 1532 HR 48, No RN notification for bradycardia, or RN assessment and follow up 1535 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1600 HR 46, No RN notification for bradycardia, or RN assessment and follow up 1625 HR 48, No RN notification for bradycardia, or RN assessment and follow up 1643 HR 48, No RN notification for bradycardia, or RN assessment and follow up 10/30/2023 1302 HR 51, No RN notification for bradycardia, or RN assessment and follow up 1335 HR 47, No RN notification for bradycardia, or RN assessment and follow up 1350 HR 47, No RN notification for bradycardia, or RN assessment and follow up 1352 HR 51, No RN notification for bradycardia, or RN assessment and follow up 1415 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1440 HR 51, No RN notification for bradycardia, or RN assessment and follow up 1505 HR 141, No RN notification for tachycardia, or RN assessment and follow up 1615 HR 52, No RN notification for bradycardia, or RN assessment and follow up 11/17/2023 Pretreatment nursing assessment: (heart rate) HR 49, the RN (registered nurse) documented a “regular rate and rhythm” Post treatment nursing assessment: HR 51, the RN documented a “regular rate and rhythm” The treatment sheet did not contain documentation that the RN recognized abnormal pre and post treatment bradycardia as abnormal findings, or conduct follow up assessment. Intra dialytic data: 1112 HR 50, No RN notification for bradycardia, or RN assessment and follow up 1142 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1201 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1206 HR 48, No RN notification for bradycardia, or RN assessment and follow up 1227 HR 46, No RN notification for bradycardia, or RN assessment and follow up 1040-1047 BP (blood pressure) increased 24 mm Hg (133/94 to 157/95), no RN notification or follow up 1142 to 1201 BP decreased 60 mm Hg (162/99 to 102/79), no RN notification or follow up 11/21/2023 1403-1424 BP (blood pressure) increased 23 mm Hg (122/88 to 145/95) systolic without notification to the RN. 1526-1551 BP increased 20 mm Hg (129/86 to 149/99) systolic without notification to the RN. Patient # 3 11/14/2023 09:46-10:12 BP decreased 34 mm/Hg (145/83-111/54) without notification to RN. Patient # 4 06/22/2023 12:36 BP 182/115 No RN notification. 13:01 BP 181/115 No RN notification. 14:41 BP 182/118 No RN notification 14:41-15:06 BP decreased 25 mm/Hg (182/118-157/112) No RN notification. Patient #5 08/07/2023 06:53 BP 78/57 No RN notification. 07:58 BP 85/32 No RN notification. 08:09 BP 89/54 No RN notification. 08:33 BP 87/48 No RN notification. 08/14/2023 07:23-07:49 BP decreased 38 mm/Hg (126/103-88/68) No RN notification. 08/16/2023 09:16 BP 80/65. Heart Rate (HR) 40. No RN notification. 09:19 BP 54/39 . HR 125. No RN notification. 09:22 BP 43/18. HR 54. No RN notification. 09:27 HR 109. No RN notification. 0954 HR 103. No RN notification. Patient #6 08/23/2023 10:33-11:09 Vital Signs (VS) greater than 30 minutes intervals (36 minutes) 11:09-12:57 VS interval 108 minutes 12:57-13:41 VS interval 44 minutes 08/25/2023 10:50 HR 50. No RN notification. 10:50-11:15 BP decreased 22 mm/Hg (150/60-172/92). No RN notification. 08/28/2023 10:37 HR 48. No RN notification. 09/01/2023 12:27 BP 181/82. No RN notification. 09/06/2023 10:36 HR 55. No RN notification. 11:04 HR 54. BP 154/132. No RN notification. 11:06 HR 55. No RN notification. Patient #7 11/06/2023 1320 to 1346 BP decreased 28 mm Hg (142/81 to 114/59). No RN notification or follow up. 1433 to 1457 BP increased 29 mm Hg (95/62 to 134/85) No RN notification or follow up. 1522 to 1547 BP increased 28 mm Hg (136/84 to 164/90), No RN notification or follow up. 11/13/2023 Pretreatment nursing assessment BP 206/96. No RN assessment or documentation recognizing abnormal reading. 1317 to 1330 BP change greater than 20 mm Hg (206/106 to 170/94). No RN notification or follow up. 1330 to 1356 BP change greater than 20 mm Hg (170/94 to 127/101). No RN notification or follow up. 1356 to 1401 BP change greater than 20 mm Hg (127/101 to 138/68). No RN notification or follow up. 1602 to 1625 BP change greater than 20 mm Hg (157/58 to 139/115) No RN notification or follow up. Post treatment nursing assessment BP 132/108. No RN assessment or documentation recognizing abnormal reading. 11/17/2023 Post treatment BP 164/89. No RN follow up or assessment for abnormal reading documented. Patient #8 0647 BP 135/102. No RN notification or follow up for abnormal reading. Employees #1 and 3 confirmed on 11/29/2023 that PCTs did not notify RNs of abnormal readings and RNs did not acknowledge and assess patients with abnormal vital signs as required by facility policy.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 49430 Based on facility policy review, record review and interviews, the facility failed to conduct a comprehensive initial assessment for a newly admitted patient (Patient #3) within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session Finding includes: 1. Policy Titled “Medical Record Quality Assurance” requires “...2. A comprehensive medical History and Physical (H&P)...accompany the new patient on admission...in accordance with DaVita policy and state regulations...” Policy Titled “Dialysis Services and Patient History and Physical Examination” requires “...A physician preforms a medical history and physical examination on the patient within 30 days before admission or within 48 hours after admission and documents the medical history and physical examination in the patient’s medical record within 48 hours after admission ....” Medical records indicate patient was admitted 08/10/23. The single History/Physical (H/P) found in patients chart dated 06/02/2023 signed by Dr Agarwal whom is not listed as a credentialed provider at the facility nor was the document authenticated by a credentialed provider. Employee #1 confirmed, on 11/29/2023, the H/P was not completed within the appropriate timeframe.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 49430 Based on facility policy review, record review and interviews, the facility’s interdisciplinary team failed to develop and implement an initial plan within 30 days of admit for a newly admitted patient (Patient #3). Finding includes: Policy Titled “Interdisciplinary Team (IDT) Patient Assessment And Plan Of Care” requires “...10. An initial Plan of Care...will be completed on all new patients...within 30 calendar days...” Patient admitted 08/10/2023. Initial Care Plan dated 09/12/2023. Employee #1, on 11/29/2023, confirmed the plan of care did not meet the 30-day requirement.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 49430 Based on review of facility policy, medical records and interview, it was determined that the facility failed to ensure: 1. That there was a documented discharge summary within 30 days of the patient’s discharge for (2) of (3) patients (#5 and #6), which poses the potential risk of lack of coordination and continuity of care; 2. AMAs (against medical advice) forms were not completed for treatment times not met for (2) of (2) patients with early termination of treatment (Patients #2 and 7); 3. That there was documented monthly Registered Nurse Progress Notes for (2) of (2) patients (Patients #2 and 3), which poses a potential risk of lack of coordination and continuity of care; and 4. That there was documented monthly Physician Progress Notes for (1) of (2) patients (Patient #2), potential risk of lack of coordination and continuity of care; and Findings Include: 1. Policy Titled “Medical Record Quality Assurance” requires “...8. A discharge note is to be entered into the medical record within 30 days of the patient’s discharge date...”. 11/28/2023, surveyor requested discharge summaries on confirmed patients. Discharged summaries were not produced by facility. Employee #3 confirmed, on 11/29/2023, absence of discharge summaries in patients #5 and 6. 2. The facility policy titled “Prescribed Treatment Time Not Met” requires: “...1. The Registered Nurse (RN) will verify that a patient signs the Early termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time....4. A copy of the Early termination of Treatment Against Medical Advice form signed by the patient, if shortened voluntarily by the patient, will be kept in the patient’s health record....”. 11/28/2023, surveyor requested AMA forms of selected patients. AMA forms were not produced by the facility. Employee #3 confirmed, on 11/29/2023, absence of AMA forms for patients #2 and 7. 3. Policy Titled “Medical Record Quality Assurance” requires “...17. Nurses are required to record patient progress notes at least monthly...”. 11/28/2023, surveyor requested monthly Nursing Progress Notes of selected patients. Medical records reveal absence of Nurse Progress Notes for the month of September and October, 2023. Employee #2 confirmed, on 11/29/2023, absence of nurse progress notes for the months of September and October, 2023 for patient #2 and 3. 4. Policy titled “Medical Record Quality Assurance” requires “...Attending physicians are required to record progress notes at least monthly. All progress notes are to be dated and signed at the time they are written or entered electronically....” 11/28/2023, surveyor requested Physician Progress Notes for selected patients. Medical records reveal absence of Physician Progress Notes for the month of September and October, 2023. Employee #2 confirmed, on 11/29/2023, absence of Physician Progress Notes for the months of September and October, 2023 for patient #2.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 37489 Based on observation and interview, the Department determined that the administrator failed to ensure staff maintained a clean and sanitary environment which has the potential risk of harm to patients due to a cluttered environment and potential exposure to contaminated sharps and supplies. Findings include: Observation on 11/27/2023 revealed generalized debris and supplies on the treatment floor around all 24 dialysis stations as follows. Stations 1/2 - dialyzer caps, paper wrappers, a syringe, fistula needle caps, and spilled bicarb Stations 3/4 - fistula needle caps Stations 5/6 - a piece of gauze and a torn dressing wrapper Stations 7/8 - plastic overwrap from supplies, CVC end caps, a syringe, and saline syringe caps Stations 9/10 - supply wrappers, paper wrappers Stations 11/12 - paper wrappers, and dialyzer caps Stations 13/14 - spilled bicarb, trash overflowing and on floor Stations 15/16 - spilled bicarb, a roll of paper tape, syringe caps Stations 17/18 - spilled bicarb, saline syringe cap, needle caps Stations 21/22 - syringe caps, paper wrappers Isolation - an open exposed needle, needle caps, wrappers Isolation - dialysis chair with cracks/tears in covering Employee #2 confirmed on 11/27/2023 that the facility was not maintained in a sanitary manner are required by policy.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff encouraged patients to wash their vascular access prior to treatment and wash their hands after termination of dialysis and holding access sites which has the potential risk of increased infection to patients through contact transmission and cross contamination. Findings include: The policy titled “Infection Control for Dialysis Facilities” requires: “...Hand Hygiene...Patients and caregivers will be encouraged to wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis...Perform hand hygiene after treatment before leaving the treatment area....” Observation on 11/28/2023 revealed (5) of (5) patients entering the treatment floor for dialysis and not asked or told to wash their vascular access prior to cannulation by staff or assisted by staff if the patient was unable to perform their own access wash. Observation on 11/28/2023 revealed (4) of (5) patients exit the treatment floor after dialysis without performing hand hygiene. Employee #2 and 3 confirmed on 11/28/2023 that staff did not follow facility policy for encouraging and/or assisting patients with washing their vascular access upon entering the treatment floor and cannulating the patients. Additionally, that staff did not encourage patients to wash their hands after dialysis before leaving the treatment areas.”

“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: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff cleaned, disinfected, and discarded and/or disinfected supplies used at the dialysis station which has the potential risk of infection to patients through cross contamination and contact transmission. Findings include: The policy titled “Infection Control for Dialysis Facilities” requires: “...Disinfection...Prior to routine disinfection, remove all visible blood...a 1:10 (one to ten) bleach solution must be utilized...Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces...using a wiping motion with friction. Sufficient disinfectant should be applied so that surfaces are visibly wet...Non-disposable items are to be disinfected after each patient use....” Observation on 11/27/2023 revealed (7) of (23) emergency take off bags at the dialysis stations were not zipped and appropriately cleaned after patient treatments. The bags contained disposable supplied and equipment visible from the opening of the bag and/or partially hanging out that were not discarded use. One dialysis take off bag was laying on the countertop behind the dialysis station and not hanging off the TV arm as were the other 23 and was not cleaned after the patient exited the station. Employee #2 confirmed on 11/27/2023 that the supplies in the take-off bags were contaminated and not discarded, nor were the bags appropriately disinfected after potential exposure to infectious agents as required by facility policy. Observation on 11/28/2023 revealed Employee #13 cleaning and disinfecting Station #13. Employee #13 did not disinfect the entire IV pole on the machine, the entire machine surface, the entire chair surfaces, and partially cleaned the TV arm. Employee #13 did not remove the hemostat hanging on the IV pole arms after the last patient left the station, left the dirty hemostat on the IV pole when setting up the machine with supplies for the next patient, and initiated treatment on the next patient before removing the dirty hemostats. Observation on 11/28/2023 revealed Employee #32 cleaning and disinfecting Station #21. Employee #21 did not disinfect the entire IV pole on the machine, the entire machine surface, the entire chair surfaces, and partially cleaned the TV arm and emergency take off bag. Observation on 11/28/2023 revealed residual dried blood spatter on (4) of (6) sharps containers. Employee #2 confirmed on 11/28/2023 that staff did not clean and disinfect the dialysis stations as required by facility policy. Observation on 11/28/2023 revealed visible blood more than an inch in diameter not cleaned off the floor at Station #6 after a patient’s treatment was completed and the station was set up and the next patient brought back to the station. Employee #2 confirmed on 11/28/2023 that the blood on the floor was not cleaned and the floor disinfected as required by policy.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff appropriately wore and changed PPE when entering and exiting the Isolation room which has the potential risk of infection through cross contamination of Hepatitis B to susceptible patients. Findings include: The policy titled “Hepatitis B Surveillance, Vaccination, Infection Control Measures and Isolation Guidance” requires: “...PPE...When entering the isolation room/area or station for any reason, physicians, NPPs, social workers, dietitians, and all other teammates will wear long-sleeved fluid resistant/fluid impervious gowns in addition to gloves, face shield, or mask and eye protection...PPE will be removed, gloves discarded, and hand hygiene performed immediately when leaving the room or area....” Observation on 11/27/2023 revealed Employees #10 and 32 enter and exit the Isolation room wearing the same PPE without changing it, or removing it after exiting the room with a Hepatitis B patient dialyzing. Employees #2 and 3 confirmed that staff did not follow the facility hepatitis infection control policy of donning PPE to enter the isolation room, or removing the PPE and performing hand hygiene as required.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 37489 Based on review of facility policy and procedure, medical records, and interview it was determined that the facility failed to ensure RNs and PCTs monitored, assessed, and documented abnormal findings for (6) of (6) patients during treatment (Patients #2, 4, 5, 6, 7, and 8). This deficient practice limits the interdisciplinary team (IDT) in addressing blood pressure, heart rate, and fluid management issues in the patient’s plan of care if treatment data is not documented, assessed, and addressed in the patient’s medical record. Findings include: The facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” requires: “...Patient data will be obtained and documented...Data collection includes...Measurement of Blood Pressure...Intradialytic Data Collection/Assessment...Vital signs and treatment monitoring...At a minimum, obtain and document...Blood pressure...Abnormal findings...will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician...as needed of changes in patient status...Abnormal Findings...Blood pressure: Pre-dialysis ...Systolic greater than 180 mm Hg ...Diastolic greater than or equal to 100 mm Hg ...Blood Pressure-Intradialytic...Difference of 20 mm/Hg increase or decrease from patient’s last intradialytic treatment BP reading ...Post Treatment ...Standing systolic BP greater than 140 mm Hg ...Standing diastolic BP greater than 90 mm Hg ...Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute....” Review of Patient Treatment Sheets reveals: Patient #2; 10/27/2023 1314 HR 50, No RN notification for bradycardia, or RN assessment and follow up 1330 HR 51, No RN notification for bradycardia, or RN assessment and follow up 1355 HR 52, No RN notification for bradycardia, or RN assessment and follow up 1420 HR 50, No RN notification for bradycardia, or RN assessment and follow up 1436 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1445 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1511 HR 50, No RN notification for bradycardia, or RN assessment and follow up 1532 HR 48, No RN notification for bradycardia, or RN assessment and follow up 1535 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1600 HR 46, No RN notification for bradycardia, or RN assessment and follow up 1625 HR 48, No RN notification for bradycardia, or RN assessment and follow up 1643 HR 48, No RN notification for bradycardia, or RN assessment and follow up 10/30/2023 1302 HR 51, No RN notification for bradycardia, or RN assessment and follow up 1335 HR 47, No RN notification for bradycardia, or RN assessment and follow up 1350 HR 47, No RN notification for bradycardia, or RN assessment and follow up 1352 HR 51, No RN notification for bradycardia, or RN assessment and follow up 1415 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1440 HR 51, No RN notification for bradycardia, or RN assessment and follow up 1505 HR 141, No RN notification for tachycardia, or RN assessment and follow up 1615 HR 52, No RN notification for bradycardia, or RN assessment and follow up 11/17/2023 Pretreatment nursing assessment: (heart rate) HR 49, the RN (registered nurse) documented a “regular rate and rhythm” Post treatment nursing assessment: HR 51, the RN documented a “regular rate and rhythm” The treatment sheet did not contain documentation that the RN recognized abnormal pre and post treatment bradycardia as abnormal findings, or conduct follow up assessment. Intra dialytic data: 1112 HR 50, No RN notification for bradycardia, or RN assessment and follow up 1142 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1201 HR 49, No RN notification for bradycardia, or RN assessment and follow up 1206 HR 48, No RN notification for bradycardia, or RN assessment and follow up 1227 HR 46, No RN notification for bradycardia, or RN assessment and follow up 1040-1047 BP (blood pressure) increased 24 mm Hg (133/94 to 157/95), no RN notification or follow up 1142 to 1201 BP decreased 60 mm Hg (162/99 to 102/79), no RN notification or follow up 11/21/2023 1403-1424 BP (blood pressure) increased 23 mm Hg (122/88 to 145/95) systolic without notification to the RN. 1526-1551 BP increased 20 mm Hg (129/86 to 149/99) systolic without notification to the RN. Patient # 3 11/14/2023 09:46-10:12 BP decreased 34 mm/Hg (145/83-111/54) without notification to RN. Patient # 4 06/22/2023 12:36 BP 182/115 No RN notification. 13:01 BP 181/115 No RN notification. 14:41 BP 182/118 No RN notification 14:41-15:06 BP decreased 25 mm/Hg (182/118-157/112) No RN notification. Patient #5 08/07/2023 06:53 BP 78/57 No RN notification. 07:58 BP 85/32 No RN notification. 08:09 BP 89/54 No RN notification. 08:33 BP 87/48 No RN notification. 08/14/2023 07:23-07:49 BP decreased 38 mm/Hg (126/103-88/68) No RN notification. 08/16/2023 09:16 BP 80/65. Heart Rate (HR) 40. No RN notification. 09:19 BP 54/39 . HR 125. No RN notification. 09:22 BP 43/18. HR 54. No RN notification. 09:27 HR 109. No RN notification. 0954 HR 103. No RN notification. Patient #6 08/23/2023 10:33-11:09 Vital Signs (VS) greater than 30 minutes intervals (36 minutes) 11:09-12:57 VS interval 108 minutes 12:57-13:41 VS interval 44 minutes 08/25/2023 10:50 HR 50. No RN notification. 10:50-11:15 BP decreased 22 mm/Hg (150/60-172/92). No RN notification. 08/28/2023 10:37 HR 48. No RN notification. 09/01/2023 12:27 BP 181/82. No RN notification. 09/06/2023 10:36 HR 55. No RN notification. 11:04 HR 54. BP 154/132. No RN notification. 11:06 HR 55. No RN notification. Patient #7 11/06/2023 1320 to 1346 BP decreased 28 mm Hg (142/81 to 114/59). No RN notification or follow up. 1433 to 1457 BP increased 29 mm Hg (95/62 to 134/85) No RN notification or follow up. 1522 to 1547 BP increased 28 mm Hg (136/84 to 164/90), No RN notification or follow up. 11/13/2023 Pretreatment nursing assessment BP 206/96. No RN assessment or documentation recognizing abnormal reading. 1317 to 1330 BP change greater than 20 mm Hg (206/106 to 170/94). No RN notification or follow up. 1330 to 1356 BP change greater than 20 mm Hg (170/94 to 127/101). No RN notification or follow up. 1356 to 1401 BP change greater than 20 mm Hg (127/101 to 138/68). No RN notification or follow up. 1602 to 1625 BP change greater than 20 mm Hg (157/58 to 139/115) No RN notification or follow up. Post treatment nursing assessment BP 132/108. No RN assessment or documentation recognizing abnormal reading. 11/17/2023 Post treatment BP 164/89. No RN follow up or assessment for abnormal reading documented. Patient #8 0647 BP 135/102. No RN notification or follow up for abnormal reading. Employees #1 and 3 confirmed on 11/29/2023 that PCTs did not notify RNs of abnormal readings and RNs did not acknowledge and assess patients with abnormal vital signs as required by facility policy.”