Davita Dialysis of Warren County

“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: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure 3 (Patient Care Technicians [PCTs] #6, #7, and #8) of 5 staff members performed hand hygiene per policy during patient care. The findings included: A facility policy titled, “Infection Control for Dialysis Facilities,” with a revision date of April 2023, indicated, “All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, e. after interacting with wall boxes (i.e., plugging/unplugging acid/bicarb lines from dialysis machine, changing acid types, when exchanging a dialysis machine), f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.” A facility policy titled, “AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose,” with a revision date of October 2022, indicated that staff should “Locate and palpate the needle cannulation sites prior to skin preparation.” Further review revealed, “Do not palpate insertion site once area has been prepped.” The policy indicated the staff should then, “Remove gloves, perform hand hygiene and put on clean gloves prior to cannulation.” On 03/18/2025 at 10:01 AM, PCT #8 was observed performing discontinuation of dialysis treatment with a central venous catheter (CVC) for the patient at station #4. The PCT removed the venous bloodline from the CVC lumen and attached it to the dialysis machine. The PCT then changed their gloves and flushed the venous lumen of the CVC. The PCT failed to perform hand hygiene when changing gloves. During an interview on 03/18/2025 at 11:24 AM, PCT #8 confirmed they were trained to perform hand hygiene when changing gloves and stated she could not think of a reason why she failed to do it then. On 03/18/2025 at 10:06 AM, PCT #6 was observed performing discontinuation of dialysis treatment with an arteriovenous fistula or graft (AVF or AVG) in treatment station #6. After reinfusing the patient’s blood, the PCT disconnected the bloodlines from the cannulation needles and connected the lines to the dialysis machine. The PCT then took off one glove, got a glove from a glove box in the treatment station, placed it on the chairside tray for the patient to use, then applied a glove to the hand that did not have a glove. The PCT did not properly remove gloves and perform hand hygiene after touching the dialysis machine and prior to removing the cannulation needles. During an interview on 03/18/2025 at 12:15 PM, PCT #6 stated that hand hygiene and glove changes should be done when going from the machine to the patient. PCT #6 indicated that he should perform hand hygiene after every glove change, but did not always do so. PCT #6 also indicated that both gloves should be removed so hand hygiene could be performed. PCT #6 confirmed that was how he was trained to perform hand hygiene. PCT #6 stated that was not done properly during the observation because he was rushing, as he had three patients whose treatment was ending at the same time and all needed to come off the machines. PCT #6 indicated that he tried to keep up with it, but often due to patient scheduling and the order the patients came in, they were coming off of treatment at the same time. On 03/18/2025 at 10:33 AM, PCT #7 was observed initiating dialysis for a patient with an AVF at station #3. The PCT applied antiseptic to the access site, palpated the access site, and then cannulated the access site. The PCT failed to perform hand hygiene prior to cannulating and failed to reapply antiseptic to the patient’s access prior to cannulation. During an interview on 03/18/2025 at 12:26 PM, PCT #7 confirmed an access site should not be palpated after an antiseptic was applied and that gloves should be changed and hand hygiene performed prior to cannulation of the access site. The PCT stated, “It completely slipped my mind.” During an interview on 03/20/2025 at 8:45 AM, the Facility Administrator confirmed it was their expectation for hand hygiene to be performed when changing gloves and prior to AVF cannulation. During an interview on 03/21/2025 at 9:53 AM, the Medical Director confirmed it was their expectation that hand hygiene be performed per facility policy, including prior to cannulating a patient’s access site.”

“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: 50873 Based on observation, interview, and facility document and policy review, the facility failed to administer parenteral medications with aseptic technique for 2 out of 3 observations of medication administration. The findings included: A facility policy titled, “Preparation and Administration of Parenteral Medications (Non-ESA, Non-Parsabiv),” with a most recent revision date of April 2024, indicated, “If the medication is in a vial, remove the vial cap, and clean vial stopper with an alcohol prep pad.” During an infection control observation on 03/18/2025 at 11:40 AM, Registered Nurse (RN) #3 withdrew Venofer (an iron supplement) from a single dose vial into a syringe without first disinfecting the stopper. The medication was taken to a patient at dialysis treatment station #10 and administered. During an infection control observation on 03/18/2025 at 11:52 AM, RN #3 withdrew Venofer (an iron supplement) from a single dose vial into a syringe without first disinfecting the stopper. The medication was taken to a patient at dialysis treatment station #10 and administered. A facility document titled “Nurse In-Center Annual Procedural Skills Verification Checklist” for RN #3 indicated RN #3 demonstrated competency in “Cleans vial stopper with an alcohol prep pad after removing the vial cap” on 03/10/2025. During an interview on 03/20/2025 at 8:45 AM, the Facility Administrator confirmed it was their expectation that the stopper of a single dose vial be cleaned with an alcohol pad prior to withdrawing the medication. During an interview on 03/21/2025 at 9:53 AM, the Medical Director confirmed it was their expectation for staff to clean the stopper of a medication vial prior to withdrawing the medication.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 50873 Based on record review, interview, and facility policy review, the facility failed to develop and implement an individualized plan of care that addressed changes in a patient’s condition per facility policies for 1 (Patient #6) out of 2 unstable patients sampled. The findings included: A facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” with a most recent revision date of October 2024, indicated, “Subsequent interdisciplinary re-assessment should be completed within the 30 days following the initiation of the re-assessment. The Plan of Care following re-assessments must be completed within 15 days of completing the re-assessment. This process would occur monthly for unstable patients and annually for stable patients.” A “Patient Plan of Care” for Patient #6, dated 01/22/2025, indicated that the patient’s status was deemed to be “unstable.” The reason listed was “concurrent conditions.” During an interview on 03/19/2025 at 10:00 AM, Registered Nurse (RN) #1 confirmed there was no evidence of a 30-day reassessment or that the plan of care had been updated to address Patient #6’s unstable status. RN #1 stated that was because the patient had not been to the clinic since the plan of care meeting on 01/22/2025. The RN confirmed it was expected that a follow-up assessment and updated plan of care be done within a month for unstable patients. During an interview on 03/19/2025 at 11:14 AM, the Regional Home Program Manager (RHPM) confirmed that the comprehensive assessment should have been filled out when it was due with the information that the patient had not been in clinic. The RHPM confirmed that the re-assessment would have been due within 30 days. During an interview on 03/21/2025 at 9:53 AM, the Medical Director (MD) confirmed it was their expectation that care plans and comprehensive assessments be updated on unstable patients every 30 days. The MD stated that the IDT regularly discussed Patient #6, but confirmed that the comprehensive assessment and plan of care updates were not completed per policy.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 50873 Based on record review, interview, and facility policy review, the facility failed to monitor patient fluid status by reporting out-of-range vital signs and blood flow rates as ordered to a registered nurse (RN) per policy for 3 (Patients #3, #4, and #5) of 8 patients in the record review sample. The findings included: A facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” with a revision date of April 2024, indicated, “If the dialysis prescription is not being met (including the dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.” Further review revealed “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary.” Further review revealed that abnormal findings included “ANY changes in patient conditions or concerns of patient well-being.” Further review revealed that abnormal findings also included “Systolic [blood pressure, the top number of a blood pressure reading] greater than 180 mm/Hg [millimeters of mercury] or less than 90 mm/Hg. Diastolic [blood pressure, the bottom number of a blood pressure reading] greater than or equal to 100 mm/Hg or less than 50 mm/Hg.” Further review revealed that abnormal findings also included “Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute [bpm] or greater than 100 beats per minute and/or an irregular heart beat.” 1. Review of a “Treatment Details Report” for Patient #3, dated 03/05/2025, revealed that at 5:45 AM, Patient Care Technician (PCT) #8 documented lowering the blood flow rate for the patient from 400 ml/hr (milliliters per hour) to 350 ml/hr due to the patient’s complaint of needle pain. There was no evidence PCT #8 notified an RN. Review of a “Treatment Details Report” for Patient #3, dated 03/07/2025 revealed that at 6:50 AM, PCT #12 obtained a blood pressure (BP) reading of 141/103 mmHg; at 7:19 AM, PCT #12 obtained a BP reading of 88/69 mmHg; at 7:40 AM, PCT #12 obtained a BP reading of 182/119 mmHg; at 7:48 AM, PCT #12 obtained a BP reading of 156/111 mmHg; at 8:18 AM, PCT #12 obtained a BP reading of 152/134 mmHg; and at 9:11 AM, PCT #12 obtained a BP reading of 157/102 mmHg. There was no evidence PCT #12 notified an RN. Review of a “Treatment Details Report” for Patient #3, dated 03/10/2025, revealed that at 6:21 AM, PCT #8 obtained a BP reading of 142/109 mmHg; at 7:00 AM, PCT #8 obtained a BP reading of 140/102 mmHg; and at 7:22 AM, PCT #8 obtained a BP reading of 77/55 mmHg. There was no evidence PCT #8 notified an RN. Review of a “Treatment Details Report” for Patient #3, dated 03/12/2025, revealed that at 6:12 AM, PCT #8 documented lowering the blood flow rate for the patient from 400ml/hr to 350ml/hr. There was no evidence PCT #8 notified an RN. Review of a “Treatment Details Report” for Patient #3, dated 03/12/2025, revealed that at 5:55 AM, PCT #8 obtained a BP reading of 139/105 mmHg and, at 8:28 AM, PCT #8 obtained a BP reading of 149/104 mmHg. There was no evidence PCT #8 notified an RN. Review of a “Treatment Details Report” for Patient #3, dated 03/14/2025, revealed that at 7:33 AM, PCT #7 obtained a heart rate reading of 46 beats per minute (bpm). There was no evidence PCT #7 notified an RN. 2. Review of a “Treatment Details Report” for Patient #4, dated 03/04/2025, revealed that at 6:46 AM, Patient Care Technician (PCT) #9 documented that the patient was “not feeling well.” There was no evidence PCT #9 notified an RN. 3. Review of a “Treatment Details Report” for Patient #5, dated 03/05/2025, revealed that at 6:01 AM, Patient Care Technician (PCT) #7 obtained a BP reading of 134/107 mmHg. There was no evidence PCT #7 notified an RN. Review of a “Treatment Details Report” for Patient #5, dated 03/06/2025, revealed that at 11:08 AM, PCT #9 obtained a BP reading of 136/105 mmHg; at 11:37 AM, PCT #9 obtained a BP reading of 144/100 mmHg; at 12:15 PM, PCT #10 obtained a BP reading of 142/117 mmHg; and at 1:37 PM, PCT #6 obtained a BP reading of 141/119 mmHg. There was no evidence PCT #9 notified an RN. Review of a “Treatment Details Report” for Patient #5, dated 03/10/2025, revealed that at 5:53 AM, PCT #6 obtained a BP reading of 167/128 mmHg; at 6:24 AM, PCT #6 obtained a BP reading of 155/125 mmHg; at 6:54 AM, PCT #6 obtained a BP reading of 170/136 mmHg; at 7:54 AM, PCT #6 obtained a BP reading of 166/130 mmHg; and at 8:23 AM, PCT #6 obtained a BP reading of 177/118 mmHg. There was no evidence PCT #6 notified an RN. Review of a “Treatment Details Report” for Patient #5, dated 03/12/2025, revealed that at 5:46 AM, PCT #6 obtained a BP reading of 148/112 mmHg; at 6:16 AM, PCT #6 obtained a BP reading of 151/112 mmHg; at 6:46 AM, PCT #6 obtained a BP reading of 148/107 mmHg; at 7:16 AM, PCT #6 obtained a BP reading of 150/113 mmHg; and at 7:46 AM, PCT #6 obtained a BP reading of 133/103 mmHg. There was no evidence PCT #6 notified an RN. Review of a “Treatment Details Report” for Patient #5, dated 03/15/2025, revealed that at 11:42 AM, PCT #10 obtained a BP reading of 136/102 mmHg and, at 1:13 PM, PCT #6 obtained a BP reading of 140/103 mmHg. There was no evidence that PCT #6 or PCT #10 notified an RN. During an interview on 03/20/2025 at 11:36 AM, PCT #6 stated that as a PCT they would notify the RN for any major changes in blood pressure; out-of-range vital signs such as systolic blood pressure readings below 100 or above 160, diastolic blood pressure readings below 60 or above 90, or heart rates below 60 or above 90; any access issues; if a patient “looks off;” missing central venous catheter dressings on entrance to the clinic; any patient injuries or potential infections; patient complaints like nausea, headache, vomiting, lightheadedness, and cramping; or if unable to run the treatment at the prescribed blood flow rate. PCT #6 stated that when the PCTs notify the RN, they should document the RN notification, what the problem was, and any interventions implemented. During an interview on 03/20/2025 at 12:20 PM, RN #2 stated that the PCTs should report nausea, vomiting, or headache; if a patient had a fall; if something was out of the ordinary; diastolic blood pressure readings above 100 or below 50, systolic blood pressure readings above 200 or below 100, heart rates below 40 or above 100; and if the patient was unable to run at the prescribed blood flow rate. RN #2 stated that she was unaware if there were any issues with PCT documentation and stated that “for sure they [the PCTs] are coming and telling me.” RN #2 stated that she usually asked the PCT to recheck the vital signs, and then she would come assess the patient. RN #2 stated that they did not always document at the time of the occurrence because sometimes there were other patient needs at the same time. During an interview on 03/18/2025 at 2:10 PM, the Facility Administrator (FA) confirmed the PCTs should notify the RN of systolic blood pressures greater than 180 and less than 90, diastolic blood pressures greater than 100 or less than 50, and heart rates greater than 100 or less than 60. The FA stated that the PCT should document they notified the RN. During an interview on 03/18/2025 at 3:40 PM, the FA confirmed their expectation was notification of an RN by a PCT when they were unable to achieve the prescribed blood flow rate and that they should document they notified the RN. During an interview on 03/19/2025 at 1:45 PM, the FA confirmed their expectation was notification of an RN by a PCT of any patient complaints or changes in the patient’s condition and that the notification of the RN should be documented. During an interview on 03/21/2025 at 9:53 AM, the Medical Director confirmed it was their expectation that the RNs be notified by the PCTs of any out-of-range vital signs, anything having to do with the patient’s access, any deviation from the dialysis prescription, any patient complaints or symptoms, or as otherwise stated per policy.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 50873 Based on interview and facility document and policy review, the Quality Assurance Performance Improvement (QAPI) program failed to track, trend, or analyze quality indicator information, with a potential negative impact for all 57 patients who received dialysis treatment at the facility. The findings included: A facility policy titled, “Continuous Quality Improvement Program,” with a revision date of April 2021, indicated that “the facility will measure, analyze, and track quality indicators or other aspects of performance.” Further review revealed, “Mortality - review of deaths” must be included in the review. A facility document “Mortality Dashboard” for the time period from February 2024 through January 2025 included information the facility was tracking regarding mortality. Information covered included causes of deaths such as cardiac, infection, gastrointestinal (GI), other deaths, cause of death not available, late entry deaths, recorded deaths, the total number of deaths, deaths less than 90 days first date of dialysis ever (FDoDE) and the gross mortality rate. The only categories with entries included: other deaths, cause of death not available, recorded deaths, late entry deaths, total deaths, and deaths less than 90 days after FDoDE. During a concurrent document review and interview on 03/21/2025 at 12:23 PM, the Facility Administrator (FA) stated that the “Mortality Prior Month’s Reporting” from January 2025, which included information from January 2024 - December 2024, was where trending, analysis, and action plans would be documented for the prior 12 months. The FA confirmed that since the document had no data available, there was nothing to review. The FA also confirmed that the document was the only place the information would have been. During an interview on 03/20/2025 at 2:33 PM, the FA confirmed that the facility was not tracking, trending, or analyzing potential contributing factors to patient deaths, such as missed treatments, relevant laboratory values, or ultrafiltration rates. The FA stated that deaths were discussed during QAPI, but those discussions were not documented. The FA stated that if there were multiple deaths in a month, the interdisciplinary team would look further to see if there were trends. The FA stated that in January of 2025 there were three deaths, and analysis of the deaths was verbal. The FA stated that there were no trends identified in the meeting, and the verbal analysis of patient deaths was not documented. The FA said no trends were identified so no action plans were implemented. During an interview on 03/21/2025 at 9:53 AM, the Medical Director confirmed their expectation was to analyze and identify trends for all required metrics, including mortality and contributing factors.”