Davita Lee’s Hill Dialysis

“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: 42929 Based on four (4) infection control observations, review of facility documents and interviews with staff, it was determined that the facility staff failed to clean and disinfect contaminated surfaces as per infection control standards and the facility’s policy. Findings: Review of the Center for Disease Control and Prevention (CDC) “Checklist: Dialysis Station Routine Disinfection” states in part: “... Part A: Before Beginning Routine Disinfection of the Dialysis Station. Disconnect and takedown used blood tubing and dialyzer from the dialysis machine. Discard tubing and dialyzers in a leak-proof container. Check that there is no visible soil or blood on surfaces. Ensure that the priming bucket has been emptied. Ensure that the patient has left the dialysis station. Discard all single-use supplies. Move any reusable supplies to an area where they will be cleaned and disinfected before being stored and returned to a dialysis station. Remove gloves and perform hand hygiene. Part B: Routine Disinfection of the Dialysis station - AFTER patient has left station. Wear clean gloves. Apply disinfectant to all surfaces in the dialysis station using a wiping motion (with friction). Ensure surfaces are visibly wet with disinfectant. Allow surfaces to air-dry. Disinfect all surfaces of the emptied priming bucket. Allow the bucket to air-dry before reconnection or reuse. Keep used or potentially contaminated items away from the disinfected surfaces. Remove gloves and perform hand hygiene. Do not bring patient or clean supplies to station until these steps have been completed....” Review of facility’s policy titled “Infection Control for Dialysis Facilities” last revised April 2023 revealed “... 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 and 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).... ii. Priming containers are to be emptied prior to disinfection.... B. Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient.... 14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses....” Observation on March 10, 2025, at 10:01 AM, EMP6 failed to disinfect the outsides of the dialysis chair under the chairside tables at station #7. Observation on March 10, 2025, at 10:13 AM, EMP5 took the temperature of the patient at station #2 and returned the thermometer to the clean area without disinfecting the thermometer. Observation on March 10, 2025, at 10:26 AM, EMP6 disinfected the dialysis machine at station #4 then proceeded to bring new supplies to the dialysis station and set up the dialysis machine prior to cleaning the dialysis chair at that station. There was a blood spill on the chairside table attached to that dialysis chair. Observation on March 10, 2025, at 11:06 AM, EMP6 failed to disinfect the inside of the prime waste bucket, the right side of the dialysis machine, and the top of the IV pole. EMP6 proceeded to bring new supplies to the dialysis station and set up the dialysis machine prior to cleaning the dialysis chair at that station. EMP6 failed to disinfect the TV monitor and arm, outsides of dialysis chair under chairside table, and the sharps container. Interview on March 11, 2025, around 11:00 AM, EMP1 and EMP13 confirmed that all parts of the dialysis station should be disinfected and agreed that the entire station should be disinfected before new supplies are brought to the station.”

“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: 42929 Based on two (2) infection control observations, review of facility documents, and interview with staff, it was determined that the facility staff failed to scrub the CVC (central venous catheter) hubs for fifteen (15) seconds as per facility’s policy. Findings: Review of the facility’s policy titled “Central Venous Catheter (CVC) With Clearguard HD Antimicrobial End Caps Procedure” last revised October 2024 states in part: “... Perform a [fifteen] second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason.... 9. Clean each CVC limb/cap with a new LARGE alcohol prep pad, starting close to the exit site and finishing with the cap.... 16. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any reside, for example blood. Hold the limbs until the antiseptic has dried....” Observation on March 10, 2025, at 10:20 AM, EMP5 wiped the CVC limb with a small alcohol prep pad starting at the exit site and finishing with the cap but failed to disinfect each CVC hub by scrubbing for fifteen (15) seconds with an alcohol prep pad as per the facility’s policy. Observation on March 10, 2025, at 10:49 AM, EMP5 wiped the CVC limb with a small alcohol prep pad starting at the exit site and finishing with the cap but failed to disinfect each CVC hub by scrubbing for fifteen (15) seconds with an alcohol prep pad as per the facility’s policy. Interview on March 11, 2025, around 11:00 AM, EMP13 indicated that the CVC hubs should be scrubbed for fifteen (15) seconds as per facility’s policy.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 42929 Based on review of facility documents and interview with staff, it was determined the facility failed to provide documentation of color vision evaluation for three (3) of six (6) personnel records reviewed (EMP8, EMP9, and EMP10). Findings: Review of the facility’s document titled “Digital Teammate Files Document Guidance Checklist” states in part: “... Clinic TM [teammate] Health Folder. Onboarding Documents ... Colormetric Test. TMs that perform testing requiring color differentiation ...” During the entrance conference on March 10, 2025, around 9:00 AM, the surveyor provided EMP1 with the personnel file worksheet to be completed to include all staff working at this facility to including the medical director, social worker, dietitian, and biomed technician. On March 11, 2025, EMP1 provided the surveyor with the completed personnel worksheet. The personnel worksheet failed to include information for the facility’s biomedical technicians, medical director, social workers, and dietitians. Interview on March 11, 2025, EMP1 indicated that EMP1 did not have the personnel information for employees that were not staff members at this facility, for example the dietitian and social worker. EMP1 indicated that the covering social worker and dietitian were not staff members at this facility but were covering the patients at this facility. The surveyor again requested the personnel worksheet be completed for all employees caring for patients at this facility and requested to specifically review all documentation for the social worker. Interview on March 12, 2025, in the morning, EMP1 indicated that EMP1 only requested the information for the social worker and did not have the documentation for the other employees. On March 12, 2025, in the afternoon, the surveyor requested the updated personnel file worksheet. EMP1 indicated that it was complete with the information that EMP1 had at that time. The updated personnel file worksheet revealed no documentation of color vision evaluation for staff that perform testing requiring color differentiation, EMP8, EMP9, and EMP10.”

“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: 42929 Based on review of personnel records, review of facility document, and interview with staff, it was determined that the facility failed to provide documentation of water, acid, and bicarb periodic audits/skills checks for three (3) of three (3) personnel records reviewed (EMP2, EMP5, and EMP6). Findings: Review of facility’s document titled “Digital Teammate Files Document Guidance Checklist” states in part: “... Annual Documents. Skills Checklist, Water Skills Checklist, Acid Concentrate Mixing Skills Checklist, Bicarb Concentrate Mixing Skills Checklist ...” Review of personnel files with EMP1 on March 11, 2025, in the afternoon revealed no documentation of initial or annual water skills audits/checklists for three (3) of three (3) staff reviewed, EMP2, EMP5, and EMP6. Interview on March 12, 2025, EMP13 provided the surveyor with the facility’s policy related to timeframes for completion of competencies and indicated that the water skills should be completed annually as per the facility’s policy. Interview on March 12, 2025, at 12:07 PM, EMP1 indicated that EMP1 did not locate the water training documentation for those three (3) employees prior to the surveyor exiting the facility.”

“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: 42929 Based on review of medical records (MR), review of facility documents, and interview with staff, it was determined the facility failed to implement the initial plan of care within the latter of thirty (30) calendar days after admission to the dialysis facility or thirteen (13) outpatient hemodialysis sessions beginning with the first outpatient dialysis session, for two (2) of seven (7) patient’s medical records reviewed (EMP4 and EMP7). Findings: Review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last revised October 2024 states in part: “... 10. An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within [thirty] 30 calendar days (or [thirteen] 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. 11. After completion of the [ninety] 90 Day re-assessment, the Interdisciplinary Team will conduct an IDT meeting to make adjustments to the Plan of Care. This meeting and initiation of the updated Plan of Care must occur within 15 days of completion of re-assessment.... New Patient: Assessment within [thirty] 30 days of admission to facility ... (or within [thirteen] 13 treatments) Plan of Care: Within [thirty] 30 days of admission to facility (or within [thirteen] 13 treatments) for new patients to dialysis ... [Ninety] 90 Day: Assessment: Re-assessment initiated on Day [ninety-one] 91, completed within [thirty] 30 days. Plan of Care: Complete patient plan of care meeting within 15 days of the completion of the re-assessment and POC....” Review of medical record for patient (MR) 1 on March 11, 2025, revealed MR1 started dialysis at the facility on January 10, 2024. The patient’s initial POC was implemented on February 9, 2024. The patient’s ninety (90) day plan of care (POC) was signed by the interdisciplinary team (IDT) and the patient on August 7, 2024, and documented as finalized on August 9, 2024, greater than 90 days after the initial POC. EMP13 indicated that there was no documentation why the POC was late. Review of medical record for MR7 on March 11, 2025, revealed MR7 started dialysis at the facility on September 19, 2024. The patient’s initial POC was not completed until December 16, 2024, three (3) months later. Interview on March 11, 2025, EMP13 indicated that MR7’s initial POC was completed late and should be completed within thirty (30) days or thirteen (13) treatments of starting dialysis, and the ninety (90) day POC should be completed within ninety (90) days after the initial POC was completed.”

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 42929 Based on review of medical records, review of facility documents, and interview with staff, it was determined the facility failed to complete POCs monthly for one (1) of one (1) unstable patient’s medical record reviewed (MR4). Findings: Review of the facility’s policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” last revised October 2024 states in part: “... 7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted: ... At least monthly for unstable patients ... Monthly (unstable patients): Assessment: Monthly until patient is determined by interdisciplinary team to be stable. Plan of Care: Complete patient plan of care meeting within [fifteen] 15 days of the completion of the re-assessment and POC....” Review of medical records for MR4 on March 11, 2025, 11:45 AM revealed MR4 was documented as unstable on POC’s dated November 10, 2023, March 31, 2024, May 29, 2024, August 28, 2024, and then stable on September 25, 2024. Interview on March 11, 2025, at 11:45 AM, EMP13 indicated that MR4 was unstable from November 2023 to September 2024. EMP13 indicated that after review of the patient’s medical record, there was no reason the patient should not have POCs completed for each month during that time, and the POCs missing were just not done, for six (6) of ten (10) months, December 2023, January 2024, February 2024, April 2024, June 2024, and July 2024, that the patient was unstable.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 42929 Based on facility document review and interview with staff, it was determined that the facility failed to provide documented evidence that the facility continuously took actions that resulted in performance improvements to ensure that improvements were sustained over time. Findings: Review of facility’s policy titled “Continuous Quality Improvement Program” last revised April 2021 states in part: “... 8. Continuous monitoring of above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained. 9. Each action plan will be evaluated as to the priority with Patient Safety and Clinical Outcomes indictors considered for the highest level of priority.” Review of the facility’s “Comprehensive Report Summary” meeting date: February 21, 2025, contained the following documentation. Percentage of missed treatments (three) 3 months was given “high” priority level. It was documented that the facility had not met this goal from October 5, 2019, through January 2025. The IP (improvement plan) start date was documented as November 11, 2019, with an anticipated completion date of May 20, 2025. The process deep dive revealed to continue to review and discuss missed treatment rate in “CTM” ... Working on opening additional shifts in the facility, with no date. The last actions and interventions documented that the Tuesday, Thursday, and Saturday schedule was set to open on May 5, 2023. This facility was currently open for treatments six (6) days a week. There was no further documentation of a current analysis of root causes, evaluation of the plan, or revision of a plan since 2023. Percentage of frequency excessive interdialytic weight gain (IDWG) was given “high” priority level. It was documented that the facility had not met this goal from June 2023 through January 2025. The IP start date was documented as June 28, 2021, with an anticipated completion date of April 30, 2025. The process deep dive was last documented in May 2024. The last actions and interventions were documented in June 2024. There was no further documentation of a current analysis of root causes, evaluation of the plan, or revision of a plan since June 2024. Percentage of transplant waitlisted was given “low” priority level. It was documented that the facility had not met this goal since February 2024. The IP start date was documented as March 23, 2020, with an anticipated completion date of May 30, 2025. The process deep dive was last documented in April 2023. The last actions and interventions were documented in April 2023. There was no further documentation of a current analysis of root causes, evaluation of the plan, or revision of a plan since April 2023. Percentage of patients who received influenza vaccination was given “high” priority. It was documented that the facility had not met this goal since the influenza season started in September 2024. The IP start date was documented as September 1, 2018, with an anticipated completion date of February 28, 2025. The process deep dive and actions and interventions were last documented as begin flu vaccine when flu shots are available for 2022-2023 flu season. There was no further documentation of a current analysis of root causes, evaluation of the plan, or revision of a plan since the documentation related to 2022-2023. Percentage of phosphorus less than or equal to 5.5 was given “high” priority level. It was documented that the facility had not met this goal from June 2023 through December 2024. The IP start date was documented as March 23, 2020, with an anticipated completion date of April 30, 2025. The process deep dive was last documented in June 2024. The last actions and interventions were documented in June 2024. There was no further documentation of a current analysis of root causes, evaluation of the plan, or revision of a plan since June 2024. Percentage of PTH (parathyroid hormone) 150-600 was given “medium” priority level. It was documented that the facility had not met this goal from June 2023 through December 2024. The IP start date was documented as September 27, 2021, with an anticipated completion date of March 31, 2025. The process deep dive was last documented in June 2024. The last actions and interventions were documented in June 2023. There was no further documentation of a current analysis of root causes since June 2024, and no evaluation of the plan or revision of a plan since June 2023. Percentage of phosphorus greater than (seven) 7 was given “high” priority level. It was documented that the facility had not met this goal from June 2023 through December 2024. The IP start date was documented as October 25, 2021, with an anticipated completion date of April 30, 2025. The process deep dive was last documented in June 2024. The last actions and interventions were documented in May 2024. There was no further documentation of a current analysis of root causes since June 2024, and no evaluation of the plan or revision of a plan since May 2024. Percentage of patients with a CVC (central venous catheter) in greater than (ninety) 90 days was given “high” priority level. It was documented that the facility had not met this goal from May 2022 through January 2025. The IP start date was documented as May 16, 2022, with an anticipated completion date of May 30, 2025. The process deep dive was last documented in June 2023. There was no date for the last actions and interventions documented. There was no further documentation of a current analysis of root causes, evaluation of the plan, or revision of a plan since June 2023. Percentage of patients great than (ninety) 90 days with a CVC was given “high” priority level. It was documented that the facility had not met this goal from May 2022 through January 2025. The IP start date was documented as May 16, 2022, with an anticipated completion date of May 30, 2025. There was no date for the documentation of the process deep dive or last actions and interventions. Percentage of AVF (arteriovenous fistula) was given “high” priority level. It was documented that the facility had not met this goal from April 2020 through January 2025. The IP start date was documented as November 11, 2019, with an anticipated completion date of May 30, 2025. There was no date for the documentation of the process deep dive or last actions and interventions. The evaluation plan was last dated July 2023. Interview on March 12, 2025, at 11:30 AM, EMP1 indicated that there was no additional documentation of the root cause analysis and actions and interventions for quality improvement metrics and activities other than the Comprehensive Report Summary that was provided. EMP1 indicated that the facility has implemented interventions and activities for those metrics not meeting goals. EMP13 indicated that the facility’s expectation is that no IP can be longer than three months and the facility should document actions and interventions.”