Dialysis Care Center Merrillville LLC

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 47022 Based on observation, record review and interview, the dialysis facility failed to ensure the appropriateness of patients’ dialysis prescription, failed to notify the physician of weight removal greater than 1 kilograms from the target weight, failed to notify the physician of Patients’ signs and symptoms of hypervolemia, and failed to obtain a new target weight from the physician when a target weight was decrease greater than 1 kilograms (See V0503), failed to ensure the RN addressed systolic blood pressure greater than 200 prior to initiation of dialysis, and failed to address elevated blood pressures during hemodialysis treatment (See V0504). The cumulative effect of the systemic problems has resulted in the dialysis facility inability to ensure the provision of quality health care in a safe environment for the condition of participation 494.80 Patient Assessment.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure Patient’s prescribed dialysis time was provided, failed to ensure elevated blood pressures were reported to the RN by the PCT, and failed to complete a post dialysis assessment (See V0543), failed to ensure the necessary care and services to achieve and sustain the clinically appropriate hemoglobin (See V0547), and failed to ensure the patients arteriovenous fistula/grafts were auscultated prior to cannulation (See V0551). The cumulative effect of the systemic problems had resulted in the dialysis facility inability to ensure the provision of quality of health care in a safe environment for the condition of participation 494.90 Patient Plan of Care.”

“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: 47022 Based on observation and interview, the dialysis facility staff failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit or other public areas in 1 of 1 dialysis facility. Findings include: 1. During an observation on 10/28/2024, beginning at 8:30 AM, a tray was noted in the corner of the facility’s conference room; on the tray was a vacutainer (container used to draw blood) with tubing to a butterfly needle. The tubing contained a red substance, and a capped syringe. 2. During an interview on 10/28/2024, beginning at 8:30 AM, the Clinical Manager indicated the tray was from a lab draw of an employee on 10/26/2024 and forgot to clean up the supplies.”

“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: 51199 Based on observation, record review, and interview, the clinic failed to ensure their staff performed hand hygiene (washing hands or using hand sanitizer) per policy in 1 of 2 observations of the initiation of hemodialysis (process of filtering blood in a patient whose kidneys do not function normally) via an arteriovenous [AV] [a connection between an artery and a vein that allows blood to flow directly from one to the other] fistula / graft [dialysis access] and in 1 of 1 observation of the discontinuation of hemodialysis of hemodialysis treatment via an AV fistula / graft, in 1 of 3 observations of the discontinuation of hemodialysis via a central venous catheter [CVC] [an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium ], and in 1 of 2 dialysis treatment station cleanings observed (PCT 3). Findings include: 1. A policy revised on 07/05/2023, titled “Cannulation of an AV Fistula or AV Graft” indicated that gloves should be changed, and hand hygiene should be performed after assessing and cleansing of the AV fistula or graft site, and before cannulating patient with the needles. 2. A policy revised 04/08/2020 titled, “Hand Hygiene” indicated an alcohol-based hand rub or antimicrobial soap and water would be utilized immediately after gloves are removed, and should be performed before performing invasive procedures such as vascular access cannulation or accessing vascular catheters. 3. During an observation on 10/28/24 beginning at 10:56AM in station 6, PCT 3 located and palpated the Patient #9’s AV fistula, PCT 3 then applied antiseptic to the access site and inserted the cannulation needles; PCT 3 failed to perform hand hygiene after locating and palpating Patients’ access site and prior to needle insertion. 4. During an observation on 10/24/24 beginning at 2:36PM at Station 5, PCT 3 reinfused the extracorporeal circuit [a system that removes blood from a patient’s body, treats it, and then returns it to the patient] and then disconnected the bloodlines and removed the cannulation needles from Patients AV access. PCT 3 failed to remove their gloves and complete hand hygiene after reinfusing circuit and before removing the access needles. 5. During an observation on 10/28/24 beginning at 9:25 AM in station 12, PCT 3 reinfused Patients #19’s extracorporeal circuit, then closed the CVC clamps, removed the CVC lines, then wiped the CVC hubs; PCT 3 failed to remove their gloves and perform hand hygiene after reinfusing the circuit and before closing CVC clamps and wiping the CVC connections. 47022 6. During an observation on 10/28/2024, beginning at 10:00 AM, PCT 3 to clean Station #8 using bleach wipes; then PCT 3 removed their gloves and applied new gloves, without hand sanitizing, left Station #8, retrieved clamps, a saline bag, and tubing, returned to station #8, and hung the saline bag on the intravenous pole in the station. 7. During an interview on 10/28/2024, beginning at 12:50 PM, PCT 3 indicated hand sanitizing should occur before working on the floor, after gloves are removed, and hand washing should occur if visible blood was on their gloves.”

“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: 47022 Based on observation, record review, and interview, the clinic failed to ensure their staff decontaminated surfaces and medical equipment in accordance with standard infection control precautions in 2 of 2 dialysis station cleaning observed (PCT 2 and 3). Findings include: 1. A policy, with revision date 12/24/2021 and titled, “Cleaning and Disinfecting Dialysis Surfaces and Equipment,” indicated dialysis staff would wipe down all non-disposable items and equipment such as vascular access camps, intravenous [IV] poles with 1:100 bleach solution after every treatment before being used on another patient. The policy indicated all equipment that was to be removed from the patient treatment area would be cleaned and disinfected with bleach solution. 2. During an observation on 10/28/2024, beginning at 10:00 AM, PCT 3 brought a new saline bag, clamps and connection tubing to Station #8 and hung the saline bag and clamps on the IV pole; PCT 3 then cleansed the station chair with a bleach solution and then wiped the IV pole and hooks with the bleach solution while the new saline bag was hanging. 3. During an observation on 10/28/2024, beginning at 10:20 AM, PCT 2 began to clean Station #1, with a cloth, dampened with a bleach solution, while the clamps from the previous patient’s treatment, remained on the IV pole. PCT 2 wiped the blood pressure cuff and then hung the blood pressure cuff on the IV pole. PCT 2 left the station, returned to station with a new saline bag and hung on the IV pole as the clamps of the previous patients treatment remained on the IV pole. PCT 2 failed to remove all supplies from the previous patient and failed to decontaminated before placing new solution and supplies for the next patients treatment. 4. During an interview on 10/28/2024, beginning at 10:25 AM, PCT 2 indicated all supplies and areas of the station are to be decontaminated before new supplies are brought to the station. She indicated the IV pole needed to be cleaned again.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the clinic failed to evidence they assessed the appropriateness of the prescribed hemodialysis [HD] (a process to filter the blood of a Patient whose kidneys do not work properly) to include their patients’ estimated dry weight [EDW] (normal body weight without extra fluid) and patients target weight, to manage their patients’ volume, failed to notify the physician the targeted weight removal was greater than 1 kilogram from the prescribed target weight, failed to notify the physician of signs and symptoms of hypervolemia (fluid overload), and failed to obtain a new target weight order from the physician when a target weight was decreased by greater than 1.0 kilograms in 2 of 2 active clinical records reviewed with a documented hospitalization and complaint of shortness of breath (Patients #2 and 5). Findings include: 1. The policy with revision date 12/16/2019 and titled, “Comprehensive Assessment and Plan of Care,” indicated the comprehensive interdisciplinary assessment would include blood pressure and fluid management. 2. The policy with revision date 10/26/2020 and titled, “Fluid Management Standing Order,” indicated the patient would be within 1 kilogram (kg) of target weight post dialysis without symptoms of hypovolemia (low body fluid) or hypervolemia (overload of body fluid). The policy indicated the target weight removal was the amount of targeted volume to remove during hemodialysis treatment. The policy indicated if the targeted weight removal was greater than 1 kg different from the target weight the physician would be notified. The policy indicated if the Patient presented with signs/symptoms of hypervolemia (shortness of breath, swelling) the targeted weight removal would be adjusted based on fluid assessment, and an order would be obtained for a new target weight from the physician if the target weight was decreased by greater than 1.0 kg. The policy indicated the algorithm should be initiated when symptoms of hypervolemia occur and consultation with the physician should be documented in the medical record. 3. An undated RN job description indicated the RN would assess Patients’ response to hemodialysis treatment therapy and make appropriate adjustments and modifications to the treatment plan and target weights as prescribed by the physician. 4. The clinical record for Patient #2 included a hemodialysis prescription, dated 10/11/2024, which indicated Patient’s estimated dry weight [EDW] was 78.0 kilograms [kg.]. A. The Treatment Flowsheet, dated 10/12/2024, indicated Patient’s EDW was 78.0 kg,; Patient’s pre-treatment weight was 84.0 kg,. Patient’s target post treatment weight was altered and set to be 80.0 kg,. Patient’s post treatment weight was 80.4 kg. Patient’s blood pressure upon treatment completion was 112/79. The documentation failed to evidence the physician was notified of the treatment target weight adjustment and the prescription EDW at 78.0 was not adjusted. B. The Treatment Flowsheet dated 10/15/2024, indicated Patient’s EDW was 78.0 kg,, their pre-treatment weight was 85.3 kg.. Patients post treatment target weight was adjusted by 1.3 kg., from the 10/12/2024 target weight, and set to be 81.3 kg.. Patient’s post treatment weight was 82.2 kg. and their blood pressure was 147/77. The documentation failed to evidence the physician was notified of the treatment target weight adjustment, Patient’s signs and symptoms of hypervolemia, and theat the EDW at 78.0 was not adjusted. C. The Treatment Flowsheet dated 10/17/2024, indicated Patient’s estimated dry weight was 78.0 kg, the Patient’s weight pre-treatment was 84.9, the Patient’s treatment target weight was 83.4 kg, the post weight was 83.5 kg, the Patient complained of shortness of breath, and swelling on the preassessment and the discharge assessment indicated the Patient complained of shortness of breath, a symptom of hypervolemia. The Treatment Flowsheet indicated the Patient’s blood pressure was elevated upon treatment completion at 190/78 (normal blood pressure 120/80), a symptom of hypervolemia. The treatment target weight was adjusted by 2.1 kg from the 10/15/2024 treatment target weight. The documentation failed to evidence the physician was notified of the treatment target weight adjustment, Patient’s signs and symptoms of hypervolemia, and the prescription EDW at 78.0 was not adjusted. The documentation failed to evidence the PCT notified the RN of the elevated blood pressure post treatment of 190/78. D. An Event Detail report, received on 10/25/2024, indicated Patient #2 did not arrive for their scheduled dialysis on 10/19/24, they felt ill and had shortness of breath [SOB]; the report indicated Patient was hospitalized from 10/19/2024 to 10/21/2024 with hyperkalemia (elevated potassium blood level) and SOB. E. A hospital dialysis treatment documentation indicated Patient received hemodialysis on 10/21/2024, in the hospital with a pre dialysis weight of 90.3 kg and the post dialysis weight was 87.3 kg. F. During an interview, on 10/28/2024 beginning at 5:00 PM, the Clinical Manager indicated Patient’s EDW and targeted weight indicated a fluid problem; she indicated the EDW should have been adjusted and the physician should have been notified. 5. The clinical record for Patient #5, included a prescription, dated 10/02/2024, with a target weight of 116.5 kilograms. A. A Treatment Flowsheet dated 10/10/2024, indicated Patient’s pre treatment weight was 118.6 kgs., their target treatment weight was set to 118.6 kgs, and the post dialysis weight was 115.9 kgs. B. A Treatment Flowsheet dated 10/11/2024 indicated Patient’s pre treatment weight was 116.3 kgs., their target treatment weight was set to be 114.3 kgs. 2.2 kg. lower than the prescripted target weight; Patients post treatment weight was 117.3 kgs. The documentation failed to evidence Patients’ dry weight was adjusted by the RN, failed to evidence the physician was notified the target weight was adjusted by more than 1.0 kg., per policy. C. A Treatment Flowsheet dated 10/15/2024 indicated Patient’s pre treatment weight was 120.5 kgs., their target treatment weight was set to be 117.5 kgs; Patients post dialysis weight was 119.3 kgs. The documentation failed to evidnece the RN addressed the post weight of more than 1.5 kg., over the treatment target weight and failed to evidence the physician was notified. D. A Treatment Flowsheet dated 10/17/2024 indicated Patient’s pre treatment weight was 120.4 kgs., their target treatment weight was set to be 117.4 kgs.; Patients post dialysis weight was 118.4 kgs. Documentation failed to evidence Patient’s prescribed dry weight was adjusted, failed to evidence the RN addressed the the post weight of 1.9 kg. over the dry weight, and the physician was notified. E. An Event Detail report indicated Patient was hospitalized from 10/19/2024 to 10/22/2024 for an emergency hypertensive (high blood pressure) and with complaints of SOB. F. During an interview on 10/28/2024, beginning at 1:45 PM, the Clinical Manager indicated Patient should have been offered an extra dialysis treatment on 10/15/2024. 6. During an observation on 10/24/2024, beginning at 1:45 PM, Patient #5 was on hemodialysis treamnet and complained of dizziness and leg cramping. The Clinical Manager instructed PCT 3 to give 200 milliliters of saline; at 1:53 PM, the clinical manager instructed PCT 3 to give Patient an additional 100 milliliters of saline. A Treatment Flowsheet dated 10/24/2024, indicated Patient’s pretreatment weight was 113.2 kilograms, their dry weight was prescribed to be 116.5 kgs., the treatment target weight was set to 112.2 kilograms. The treatment flowsheet failed to evidence the Clinical Manager notified the physician of a treatment target weight adjustment from 10/17/2024 to 10/24/2024 of 5.2 kilograms. 7. During an interview on 10/28/2024, beginning at 1:25 PM, the Clinical Manager indicated the RN should review the treatment flow sheet report at the end of every day to review weight and blood pressures. The Clinical Manager indicated a systolic blood pressure greater than 160 should be reported by the PCT to the RN. 8. During an interview on 10/28/2024, beginning at 2:20 PM, the Medical Director indicated if a Patient had complaints during hemodialysis, the EDW would be adjusted by the physician; the physician indicated they audited the dry weights every 2 weeks. The MD indicated if a Patient complained of cramping and received more than 100 milliliters of saline, the physician should be notified.”

“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: 47022 Based on record review and interview, the dialysis facility failed to evidence the RN evaluated elevated blood pressures prior to initiation of hemodialysis [HD] (a process to filter the blood of a Patient whose kidneys do not work normally) and failed to evidence elevated blood pressure [BP] were addressed by the RN during hemodialysis treatment in 1 of 1 clinical records reviewed with a pre-dialysis systolic (top blood pressure number) greater than 200 (Patient #5). Findings include: 1. A Standing Order revised on 12/2018, titled, “Blood Pressure Parameters Standing Order,” indicated if systolic blood pressure (top number of blood pressure) was greater than 200, or if the diastolic blood pressure was greater than 120 the physician would be notified, the clonidine (blood pressure lowering medication) standing order would be followed, and dialysis would not be initiated. 2. A revised Clonidine standing order dated 12/2018, titled, “Physician Hemodialysis Medication Standing Orders indicated Clonidine for Hypertension (high blood pressure) greater than 200 systolic would include notifying the nephrologist (kidney doctor) before administering, give clonidine 0.1 milligrams (mg) and recheck blood pressure 30 minutes after administrating, if blood pressure remains elevated above systolic blood pressure 200 give a second dose of clonidine 0.1mg and recheck blood pressure in 30 minutes, may give a third tablet of 0.1 mg if blood pressure was not responding to the prior doses of clonidine, reassess the patient’s blood pressure in 30 minutes and notify the nephrologist if the Patient’s systolic blood pressure remained greater than 200 after administration of 3 clonidine tablets. 3. Patient #5’s clinical record review evidenced the following: A. The HD Treatment Flowsheet, dated 10/05/2024, indicated hemodialysis [HD] treatment was started at 10:24 AM and evidenced Patients’ BP was 207/108 at 10:24 AM; the documentation failed to evidence the PCT notified the RN 1) At 1:54 PM, Patients BP was 203/95 with RN notification documented 2) At 2:26 PM, Patients BP was document as 215/99 3) Post HD treatment assessment documented Patients BP was 219/111 sitting and 222/99 standing 4) Documentation indicated clonidine 0.1mg was given at 2:41 PM and Patient was discharged from clinic at 2:48 PM. 5) The record failed to evidnec RN 3 addressed Patients’ elevated BP, after notification from PCT, failed to evidence the physician was notified prior to initiation of dialysis at 10:24 AM, and failed to evidence RN 3 followed the clonidine standing order protocol. B. The HD Treatment Flowsheet, dated 10/08/2024, indicated HD was started at 10:10 AM and evidenced Patients’ BP was 248/129 1) Documentation at 10:26 AM indicated a blood pressure of 250/132 and clonidine 0.2mg was given 2) Patients BP at 11:10 AM was 208/78 3) Patients’ BP at 12:10 PM was 209/98 4) Documentation failed to evidence RN 1 notified the physician of the elevated BP prior to initiation of hemodialysis, failed to evidence RN 1 followed the clonidine standing order protocol, and failed to evidence RN 1 obtained an order for the Clonidine 0.2 mg. administered. C. The HD Treatment Flowsheet, dated 10/10/2024, indicated HD began 10:11 AM and evidenced Patients’ BP was 191/90 1) At 12:41 PM the BP was 200/106 with RN 4 notification documented 2) At 2:11 PM, documentation indicated the HD treatment was completed and the BP was 203/95. The documentation failed to evidnece the RN was notified of teh elevated BP 3) Documentation failed to evidence RN 4 implemented the clonidine standing order protocol and failed to evidence PCT 3 notified the RN of the elevated BP prior to discharge. E. An Event Detail report indicated Patient was hospitalized from 10/19/2024 to 10/22/2024 for an emergency hypertensive (high blood pressure) and with complaints of SOB. 4. During an interview on 10/28/2024, beginning at 1:45 PM, the Clinical Manager indicated the PCT should notify the RN of elevated BP, the Clonidine should have been given for systolic BP greater than 200 prior to initiation of hemodialysis, indicated Patient should not be started on HD if the systolic BP was greater than 200. The Clinical Manager indicated if the Clonidine 0.2mg was ordered by the physician, outside of the parameters, there should be documentation of the physician notification and the order with prescribed dose. 5. During an interview on 10/28/2024, beginning at 1:25 PM, the Clinical Manager indicated a systolic BP greater than 160 should be reported by the PCT to the RN.”

“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: 47022 Based on observation, record review and interview, the dialysis facility failed to ensure the dialysis prescribed hemodialysis [HD] (process to filter the blood of a patient whose kidneys do not work normally) time was provided to the Patient as ordered in 1of 1 Patient interviewed with complaints of incorrect treatment times provided (Patient #3), failed to evidence blood pressures [BP] greater than 160 systolic (top blood pressure number) were reported to the RN in 2 of 2 clinical records reviewed with a documented complaint (Patient #3 and 4), failed to evidence vital sign documentation was completed every 30 minutes in 1of 1 clinical record reviewed of a discharged /transfered Patient (Patient #4), and failed to complete a post dialysis assessment in 1 of 1 Patient observation with physical complaint while on the treatment floor on 10/28/2024 (Patient #19). Findings include: 1. A revised policy dated 12/16/2019, titled, “Comprehensive Assessment and Plan of Care,” indicated the comprehensive patient plan of care would include maintaining the prescribed dose of dialysis to meet dialysis adequacy. 2. An undated RN job description indicated the RN would assess the Patients’ response to hemodialysis treatment therapy and make appropriate adjustments and modifications to the treatment plan as prescribed by the physician. 3. An undated PCT job description indicated the PCT would enter prescribed treatment into the dialysis machine, monitoring vital signs during treatment, and report abnormal findings or change in Patient status to the RN. 4. The clinical record for Patient #3 included a review of: A. A Treatment Flowsheet, dated 10/09/2024, that indicated the HD treatment duration prescribed was to be 3 hours and 30 minutes. The documented treatment initiation was 10:53 AM and the treatment ended at 2:00 PM, for a total of 3 hours and 7 minutes of HD. The documentation failed to evidence the reason for a shortened HD treatment. B. A Treatment Flowsheet, dated 10/14/2024, indicated HD remained prescribed for 3 hours and 30 minutes. The documented treatment initiation was 11:13 AM and the treatment end time was 2:22 PM, for a total of 3 hours and 9 minutes. The documentation failed to evidence the reason for a shortened treatment time. An elevated blood pressure of 190/62 was documented by PCT 4 at 11:43 AM; the documentation failed to evidence the PCT notified the RN. C. A Treatment Flowsheet, dated 10/16/2024, indicated HD treatment was started at 10:27 AM. A BP of 184/62 was documented by PCT 4 at 11:27 AM; the documentation failed to evidence the PCT notified the RN. D. A Treatment Flowsheet, dated 10/28/2024, indicated HD treatment was completed at 2:43 PM with a BP of 183/69 and a post assessment BP of 179/71; the documentation failed to evidence the RN was notified of the elevated BP’s. The documented discharge time from the clinic was 2:50 PM. E. During an interview on 10/28/2024, beginning at 5:30 PM, the Clinical Manager indicated the prescribed treatment time was manually entered into the HD machine by the PCTs and Patient did not receive the correct prescription time. F. During an interview on 10/28/2024, beginning at 1:25 PM, the Clinical Manager indicated PCTs should notify the nurse of systolic BP reater than 160 during HD. G. During an interview on 10/28/2024, beginning at 12:50 PM, PCT 3 indicated BP greater than 160/90 should be reported to the RN during hemodialysis. 5. A Treatment Flowsheet, dated 10/07/2024, for Patient #4 indicated their HD treatment was initiated at 3:44 PM, at 4:48 PM, their BP was elevated at 161/101. Documentation failed to evidence PCT 4 notified the RN. The documentation failed to evidence a BP was assessed until 6:33 PM and was 164/98. The flowsheet failed to evidence the Patient’s vital signs were assess every 30 minutes from 4:48 PM to 6:33 PM. During an interview on 10/28/2024, beginning at 12:50 PM, PCT 3 indicated a Patient should have vitals signs and assessment documented by the PCT every 30 minutes during HD. 6. During an observation on 10/28/2024, beginning at 9:05 AM, Patient #19 was observed wincing, eyes closed, holding head when approached the Patient indicated he/she got headaches during dialysis, had a headache and would take Tylenol (pain reliever) and had not received Tylenol yet. At 9:15 AM, PCT 3 was observed disconnecting Patients’ central venous catheter (dialysis access) from HD; Patient was observed exiting the dialysis floor at 9:25 AM. Observation failed to evidence the Clinical Manager /RN assessed Patient prior to discharge. During the observation the Clinical Manager /RN was on the other side of the dialysis floor at Station #9. During an interview on 10/28/2024, beginning at 1:25 PM, Clinical Manager/ RN indicated that post HD assessments are not always completed and indicated they did not complete a post assessment on Patient #19. A Treatment Flowsheet dated 10/28/2024 included documentation by the Clinical Manager/ RN of a discharge assessment that indicated Patient was alert and oriented, had no pain, no edema, no change in skin status, no shortness of breath, no gastrointestinal problem, and lungs sounds were clear and documented at 12:39 PM. During an interview on 10/29/2024, beginning at 1:15 PM, the Clinical Manager/ RN indicated that on 10/28/2024, she did not conduct a post assessment on Patient #19 prior to discharge; she indicated she saw Patient from across the room and should not have documented an assessment was completed on 10/28/2024, as it was not completed.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 47022 Based on record review and interview, the dialysis facility failed to provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin (blood count) in 2 of 4 Patients clinical records reviewed that received Venofer (iron medication) and Epogen (medication used to increase red blood cell production) (Patient #5 and #13). Findings include: 1. The clinical record for Patient #5 included a Medication Order, dated 10/11/2024, for Venofer 100 milligrams to be administered intravenously [IV] push with every hemodialysis [HD] treatment, with an end date of 11/03/2024. The record included a Medication Order, dated 10/11/2024, for Epogen 10,000 units IV push with every HD treatment; the order did not have an end date. A Treatment Flowsheet, dated 10/24/2024, for Patient #5 failed to evidence documentation Patient received Venofer or Epogen on 10/24/2024. During an interview, on 10/28/2024 beginning at 1:45 PM, the Clinical Manager indicated Patient should have received the Venofer and Epogen on 10/24/2024, as ordered; she indicated the RN forgot to give to the medications. 2. The clinical record for Patient # 13 included a Medication Order, dated 09/25/2024, for Epogen 8,000 units to be administered with every HD treatment; the order did not have an end date. The record included a Medication Order, dated 10/06/2024, for Venofer 100 milligrams to be administered every 7 days, on Tuesdays, without an end date. The HD treatment sheet, dated 10/15/2024 [a tuesday] failed to evidence epogen was administered as ordered. The HD Treatment Flowsheet, dated Tuesday 10/22/2024, failed to evidence Venofer was administered. The HD treatment flowsheet, dated 10/24/2024, failed to evidence Epogen or Venofer was administered. During an interview, on 10/28/2024 beginning at 2:10 PM, the Clinical Manager indicated Patient did not receive the Venofer or Epogen as was ordered.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 47022 Based on observation, record review and interview, the dialysis facility staff failed to auscultate (listen) to the arteriovenous fistula (AVF) (dialysis access) / arteriovenous graft (AVG) (dialysis access) prior to cannulation (needle insertion) of the site to receive hemodialysis (a process to filter the blood of a Patient whose kidneys do not work normally) in 3 of 4 observations of a AVF /AVG site initiation (PCT 2 and 3). Findings include: 1. A revised policy dated 03/08/2019, titled, “Assessing an Internal (AVF/AVG) Vascular Access,” indicated the hemodialysis access would be assessed before each dialysis cannulation. The policy indicated the AVF/AVG site would be auscultated for changes in the bruit (a sound heard through a stethoscope) from the previous treatment that could indicate potential clotting. The policy indicated if a bruit was not present the AVF/AVG should not be cannulated. 2. An undated PCT Job Description indicted the PCT would perform vascular access evaluation pretreatment. 3. During an observation on 10/25/2024, beginning at 3:15 PM, Patient #16 arrived to Station #3, PCT 2 palpated (touched) the AVF site and cleaned the right arm AVF with alcohol pads. PCT 2 cannulated the AVF site and failed to auscultate the AVF with a stethoscope prior to cannulation. 4. During an observation on 10/28/2024, beginning at 10:30 AM, Patient #10 arrived to station #8, PCT 3 palpated the AVF site and cleaned the right arm AVF with alcohol pads. PCT 3 cannulated the AVF site and failed to auscultate the AVF with a stethoscope prior to cannulation; neither PCT 3 nor Station #8 had a visible stethoscope. 5. During an observation on 10/28/2024, beginning at 10:47 AM, Patient #9 arrived to station #6, PCT 3 palpated the AVF site and cleaned the left arm AVF with alcohol pads. PCT 3 cannulated the AVF site and failed to auscultate the AVF with a stethoscope prior to cannulation, PCT 3 and Station #6 did not have a visible stethoscope. 6. During an interview on 10/28/2024, beginning at 12:15 PM, PCT 2 indicated an AVF/AVG site assessment should include listening for a bruit with a stethoscope prior to cannulation. 7. During an interview on 10/28/2024, beginning at 12:50 PM, PCT 3 indicated an AVF/AVG site assessment should include listening for a bruit with a stethoscope prior to cannulation but probably didn’t listen for a bruit today.”

“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: 47022 Based on record review and interview, the dialysis facility failed to ensure evidenced continuous monitoring of Hepatitis B (liver infection) immunizations and performance improvement were tracked to ensure improvements were sustained in 1 of 1 dialysis facility. Findings include: A policy, dated 07/15/2022 and titled, “Hepatitis B Vaccination,” indicated if the Hepatitis B surface antibody was less than 10 (susceptible) the patient should receive a booster dose of the Hepatitis B vaccine. A September 2024 QAPI (quality assessment performance improvment) document for the labs reviewed for August 2024 indicated 35% of their patients had a Hepatits B surface antibody greater than 10 (immune), 8% of their patients were in a Hepatitis B vaccine series, 30% of their patients declined the Hepatitis B vaccine, and 2% of their patients were non-converters (not immune to Hepatitis B after vaccine). The documentation failed to evidence 15 [25%] of their 60 patients were monitored in August. During an interview on 10/29/2024, beginning at 2:20 PM, the Corporate Clinical Manager indicated they were not aware of why their QAPI did not evidence monitoring of every patient. She indicated they would need to audit as to why 14 patient’s were not included / monitored. She indicated QAPI had not yet reviewed the September 2024 Hepatitis B labs. During an interview, on 10/30/2024 beginning at 9:20 AM, the Clinical Manager indicated she audited the facility’s Hepatitis B vaccine monitoring on 10/29/2024 and determined 30 of their current 58 patients have declined a Hepatitis B vaccine. The October QAPI report of the Hepatitis B labs for September 2024, were provided for review on 10/30/2024; the report indicated 33% of their patients were immune to Hepatitis B, 8% were in a Hepatitis B vaccine series, 50% of their patients declined the Hepatitis B vaccine, and 3% of their patients were nonconverters. The facilities September and October 2024 Hepatitis B vaccine reports failed to evidence the facility’s percentage, of patients accepting a vaccine or were immune to Hepatitis B, improved. The documentation failed to include 6 % of the patients were tracked in October of 2024.”

“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: 47022 Based on observation, record review, and interview, the dialysis facility failed to maintain complete and accurate records in 2 of 6 active clinical records reviewed (Patient #3 and 5) and in 1 of 2 patients observed on the incenter treatment floor that verbalized pain with their hemodialysis [HD] (Patient #19) and 1 of 3 arteriovenous fistula access observed (Patient #16). Findings include: 1. During an observation on 10/24/2024, beginning at 1:45 PM, Patient #5 was receiving hemodialysis [HD] in Station #8, Patient complained of cramping to right foot. At the station, the Clinical Manager instructed PCT 3 to give Patient 200 milliliters of saline. PCT 3 hung a 1000 milliliter bag labeled saline. Patient continued to complain of cramping and dizziness and the Clinical Manager indicated to PCT 3 to give an addition 100 milliliters of fluid. At 2:00 PM Patient’s symptoms had subsided and PCT 3 discontinued the needles from the arteriovenous graft (dialysis access). The saline bag had approximately 300 milliliters remaining after Patient was disconnected. A review of the Treatment Flowsheet dated 10/24/2024 indicated at 2:17 PM Patient was discharged and 250 milliliters of saline was administered; the post assessment documented the total normal saline administered was zero. The documentation failed to evidence the amount of saline administered by PCT 3, as directed by the clinical manager. During an interview on 10/28/2024, beginning at 12:50 PM, PCT 3 indicated he/she had given the Patient 300 milliliters of saline, and the Clinical Manager/floor RN had given the Patient 200 milliliters of saline. During an interview on 10/28/2024, beginning at 1:45 PM, the Clinical Manager/ RN indicated Patient received 350 milliliters of saline on 10/24/2024 and the PCT should have entered the correct amount of saline into the post assessment for the total saline given during treatment and did not. A Treatment Flowsheet dated 10/24/2024 indicated Patient’s dry weight was 116.5 kilograms. Patients 10/24/2024 weight was 113.2 kilograms, with a treatment target weight entered of 112.2 kilograms; Patients post weight at discharge was documented 102.9 kilograms. During an interview on 10/28/2024, beginning at 1:25 PM, the Clinical Manager indicated the post weight was incorrect, probably was 112.9 kilograms, and indicated weights should be evaluated during chart review at the end of each treatment day to evaluate for adjustments needed. 2. The clinical record for Patient # 3 evidenced the following: A Treatment Flowsheet, dated 10/16/2024, indicated Patient’s HD duration time was prescribed to be for 3 hours and 30 minutes; the HD began at 10:27 AM and ended at 2:27 PM, documentation indicated a 4 hour HD treatment time. The Post Assessment dialyze time indicated Patient’s dialyzed time was 3 hours and 30 minutes. A Treatment Flowsheet, dated 10/23/2024, indicated Patient’s HD duration time remained prescribed at 3 hours and 30 minutes; the HD start time was 10:17 AM and treatment end time was documented as 2:20 PM, indicated a 4 hour and 3 minute HD treatment time. The Post Assessment dialyze time indicated Patient’s dialyzed time was 3 hours and 30 minutes. During an interview on 10/28/2024, beginning at 5:30 PM, the Clinical Manager indicated the treatment times were documented incorrectly, was a documentation error. 3. During an observation on 10/28/2024, beginning at 9:05 AM, Patient #19 was observed wincing, eyes closed, holding head when approached Patient indicated he/she developed headaches during HD, had a headache and would take Tylenol (pain reliever) and had not received yet. During an observation on 10/28/2024, beginning at 9:15 AM, PCT 3 was observed disconnecting Patient from HD; Patient was observed exiting the dialysis floor at 9:25 AM. During the observation, the PCT failed to notify the RN of Patient’s complaints; during the observation it was observed the RN / Clinical Manager failed to assess the Patient prior to discharge. During the observation on 10/28/2024, the Clinical Manager/floor RN was on the other side of the dialysis floor at Station #9. During an interview on 10/28/2024, beginning at 1:25 PM, Clinical Manager/floor RN on 10/28/2024 indicated that post assessments are not always completed, indicated she was not notified Patient #19 had complaints of headaches prior to discharge and she relayed she did not complete a post assessment on Patient #19. The 10/28/2024 Treatment Flowsheet included documentation, by the Clinical Manager/floor RN on the same day at 12:39 PM, a discharge assessment that indicated Patient was alert and oriented, had no pain, no edema, no change in skin status, no shortness of breath, no gastrointestinal problem, and lungs sounds were clear. During an interview on 10/29/2024, beginning at 1:15 PM, the Clinical Manager/floor RN indicated they did not she did not conduct a post assessment on Patient #19 on 10/28/2024, prior to discharge. The clinical manager indicated they saw Patient being discharged from across the room and should not have documented an assessment that was not conducted. 4. During an observation on 10/25/2024, beginning at 3:15 PM, Patient #16 arrived to Station #3, PCT 2 palpated (touched) the aeteriovenous fistula [AVF] site and cleaned the right arm AVF with alcohol pads. PCT 2 cannulated the AVF site and failed to auscultate the AVF with a stethoscope prior to cannulation. 5. A review of the Treatment Flowsheet for Patient #16, dated 10/25/2024, indicated the AVF was auscultated for the bruit during assessment and was present. 6. During an interview on 10/28/2024, beginning at 12:15 PM, PCT 2 indicated an AVF/AVG site assessment should include listening for a bruit with a stethoscope prior to cannulation.”

“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: 47022 Based on observation, record review and interview, the dialysis facility failed to ensure the bleach solutions were prepared and labeled per the facility’s policy to minimize the transmission of infectious agents for 1 of 1 facility (Day 1 08/05/2024 of 2 Observation Days). Findings include: 1. A revised policy dated 12/20/2022, titled, “Preparing Bleach Solutions,” indicated the use of a 1:100 dilution of bleach to decontaminate equipment after each dialysis treatment, and use of a 1:10 dilution of bleach for cleaning a greater than 10 milliliter spills of blood. The policy indicated the bleach solutions would be stored in labeled containers. The policy indicated the procedure to prepare 1:10 bleach solution would include mixing 1 part bleach with 9 parts water, and to prepare 1:100 bleach solution would include mixing 1 part bleach to 99 parts water. The policy indicated to pour measured amount of bleach into the measured amount of water to mix the bleach solution and to label the container with the strength of the solution. 2. During an observation on 08/05/2024, beginning at 8:35 AM, 2 containers were noted near the clean sink of the east wall of the facility, on one of the containers the 1:10 was circled and on the other container the 1:100 was circled. During the observation no instructions to prepare the bleach solutions were visible, both containers had solution only in them and were at 2 different fluid levels. 3. During an interview on 08/05/2024, starting at 9:00 AM, Patient Care Technician (PCT) 3 indicated both of the containers contained 1:100 bleach solution. PCT 3 indicated 10 milliliters of bleach was put in each container and water was filled to the plastic container ridge line, no visible markings were on the container. PCT 3 indicated the amount of water mixed with the bleach was not measured and one container was for cleaning dialysis stations and one container was for the used forceps disinfection. 4. During an observation and interview on 08/05/2024, starting at 12:40 PM, the Clinical Manager indicated there were not bleach mixing solutions instructions posted on the dialysis facility’s floor and the PCT’s would know the mixing solution instructions from training on the policy during orientation. During the observation PCT 3 indicated to the Clinical Manager that both containers next to each other were 1:100 bleach solution, and he/she did not measure amount of water added to the bleach and filled water to the container ridge line. The Clinical Manager indicated the bleach solutions were not labeled correctly and not made correctly, both containers were emptied and the Clinical Manager instructed PCT 3 on the correct bleach solution mixing instructions. The Clinical Manager indicated one container should be labeled 1:10 bleach solution and the other container should be labeled 1:100 bleach solution.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. 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 as 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 This Standard is not met as evidenced by: 47022 Based on observation, record review and interview, the dialysis facility failed to ensure the initiation of hemodialysis (process of filtering the blood of a person whose kidneys are not working properly) to a patient with a central venous catheter (CVC)(a catheter placed into a large vein) was performed per the facility’s policy in 1 of 2 dialysis initiations observed of a patient with a central venous catheter (Patient #14). Findings include: 1. A revised policy dated 08/25/2023, titled, “Initiating Dialysis Treatment with a Central Venous Catheter ...” indicated the initiation of hemodialysis treatment using a central venous catheter would be performed using aseptic technique per the dialysis policy and procedures to ensure patient safety. The policy indicated a 15-30 second 70% alcohol scrub would be performed on the CVC hubs (connectors to CVC) with each connection during initiation of treatment. 2. During an observation on 08/05/2024, beginning at 10:50 AM, for Patient #14 at Station #10 Patient Care Technician 3 (PCT) was observed cleansing the Patient’s CVC blue hub with an alcohol swab for 5 seconds and the CVC red hub was cleansed for 7 seconds with an alcohol swab and syringes were then observed being inserted into the red and blue hubs. 3. During an interview on 08/05/2024, beginning at 11:10 AM, PCT 3 indicated he/she did not do a time count for wiping the Patient’s CVC hubs with alcohol swabs and would just swab the lines with alcohol and insert the syringes. 4. During an interview on 08/05/2024, beginning at 4:20 PM, the Clinical Manager indicated he/she would have to look up the facility’s policy to know how long the CVC hubs were to be cleansed prior to initiation of hemodialysis. 5. During an interview on 08/06/2024, beginning at 10:38 AM, PCT 4 indicated the CVC hubs should be cleansed with an alcohol swab for at least 15 seconds prior to initiation of hemodialysis.”

“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: 47022 Based on record review and interview, the dialysis facility failed to ensure the hemodialysis (process of cleaning blood of a person whose kidneys are not working normally) machines were maintained and operated in accordance with the manufacturer’s recommendations in 14 of 14 hemodialysis Baxter AK 98 hemodialysis machines for 1 of 1 facility. Findings include: 1. A Policy dated 08/13/2019 titled, “Preventative Maintenance Schedule for Equipment,” indicated preventive maintenance schedules would be in accordance with the manufacturer’s recommendations for equipment used to perform a patient treatment. 2. A Baxter Direction for Use indicated an authorized service technician would carry out preventative maintenance at least every other year, and how often depended on the environment the dialysis machine was in. 3. A Baxter Dialysis Products and Equipment Purchase Agreement dated 08/05/2022 indicated performance of scheduled preventative maintenance procedures was the responsibility of the purchaser and was not covered by the AK 98 Equipment warranty however, if the purchaser opted to receive the extended warranty the AK 98 equipment warranty would be lengthened to incorporate the extended warranty after the initial 12 months of warranty had expired, and the extended warranty included one preventative maintenance check after the initial 12 months of warranty. 4. A Service Report dated 08/16/2022 indicated hemodialysis machine Baxter AK 98 serial #AK062851 was installed. A Service Report dated 12/19/2022 indicated a field repair was performed on serial #AK062851. A Service Report dated 01/06/2023 indicated a field repair was performed on serial #AK062851. A Service Report dated 01/27/2023 indicated a field repair was performed on serial #AK062851. A Service Report dated 02/03/2023 indicated a field repair was performed on serial # AK062851. A Service Report dated 02/01/2024 indicated a field repair was performed on serial #AK062851 with operating hours of 4039. A Service Report dated 07/08/2024 indicated a field repair was performed on serial #AK062851. 5. A Test Date Report dated 08/18/2022, indicated the hemodialysis machine Baxter AK 98 Serial #AK062835 was installed. A Service Report dated 02/29/2024 indicated a field repair was performed on serial #AK062835 with operating hours at 5040. A Service report dated 04/19/2024 indicated a field repair was performed on serial #AK062835 with operating hours at 5545. 6. A Test Date Report dated 08/18/2022, indicated the hemodialysis machine Baxter AK 98 Serial #AK062848 was installed. A Service Report dated 11/28/2023 indicated a field repair was performed on serial # AK062848 with operating hours at 3271. A Service Report dated 02/14/2024 indicated a field repair was performed on serial #AK062848 with operating hours at 3965. 7. A review of the hemodialysis machines failed to evidence preventative maintenance had been scheduled, failed to evidence preventative maintenance would be completed per the manufacturer’s directions for use of every other year, and failed to evidence a new contract had been completed to include preventative maintenance. 8. During an interview on 08/06/2024, beginning at 11:30 AM, the Biomed Tech indicated the hemodialysis machines Baxter AK 98 were purchased in August of 2022 and preventative maintenance was due in August 2024. The Biomed Tech indicated the preventative maintenance could be completed only by the Baxter techs per contract, and preventative maintenace had not been scheduled yet with Baxter and there was not a new contract signed with Baxter and the dialysis facility. 9. During an interview on 08/08/2024, beginning at 11:00 AM, the Biomed Tech indicated the hemodialysis machines’ preventative maintenance had to be scheduled and 2 to 4 hemodialysis machines per week would be completed until the 14 machines at the facility were completed.”

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by: 47022 Based on record review and interview the dialysis facility failed to evidence the plan of care was revised or updated per the facility’s policy for an unstable patient in 1 of 1 unstable patient clinical records reviewed. (Patient #1). Findings include: A revised policy dated 12/16/2019, titled, “Comprehensive Assessment and Plan of Care,” indicated an unstable patient must be reassessed and a new plan of care completed and reviewed monthly until the patient was deemed to be stable. A Plan of Care dated 05/30/2024 with an effective date of 05/13/2024 indicated Patient #1 was unstable due to ineffective medication regimen related to pain control, recent hospitalization, noncompliance with taking medication, and noncompliance to diet and treatment. The Plan of Care indicated the next plan of care meeting was projected to be done on 06/30/2024. The clinical record failed to include documentation the plan of care meeting or update was completed on or after 06/30/2024. During an interview on 08/08/2024, beginning at 12:55 PM, the Clinical Manager indicated the unstable patient should have had an updated plan of care every 30 days and an updated plan of care was not completed on or after 06/30/2024. During an interview on 08/08/2024, beginning at 1:30 PM, Social Worker 1 indicated the plan of care meeting should have been scheduled monthly for an unstable patient and had not been completed.”

“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: 47022 Based on record review and interview, the dialysis facility failed to ensure the quality assessment and performance improvement (QAPI) program tracked quality indicators that reflected the process of care and facility operations for Hepatitis B (a liver infection caused by a virus), and Kidney (organ that regulates fluid and excretes urine) Transplantation; and failed to evidence the facility had a process to identify patients that were eligible for transplant to provide education and tracking in 1 of 1 dialysis facility quality assessment and performance improvement program. Findings include: 1. A revised policy dated 04/23/2021, titled, “Quality Assessment and Performance Improvement Policy,” indicated each in center dialysis facility would maintain and demonstrate evidence of its QAPI program. The policy indicated the dialysis facility would monitor its performance, take actions that result in performance improvements, and track performance to ensure sustained performance. 2. A revised policy dated 05/29/2019, titled, “Hepatitis B Screening and Surveillance,” indicated the dialysis facility wound ensure physician orders are obtained for hepatitis B vaccination for those patients determined to be hepatitis B susceptible. 3. An End Stage Renal Disease Application and Survey and Certification Report (CMS_3427) completed on 08/05/2024 indicated in center hemodialysis patient census was 58. 4. A Dialysis Facility Report for Fiscal Year 2024 indicated the 2022 facility’s kidney transplant wait list was 0.5% which was 16% lower than the national adjusted percentage. A QAPI Transplant Report for kidney transplantation indicated for April 2024 the current census was 48, the area for number of transplant education to patients, transplant evaluation in process, patient’s ineligible and patient refused transplant are blank with 4% of patients on the wait list that are less than 75 years old (patients less than 75 years old are eligible for kidney transplant, patients older than 75 years old are not eligible). The May 2024 Transplant Report indicated 46 was the current census, 8% of patients received transplant education, 7% of patients had transplant evaluations in process, 24% of patients were ineligible, 7% of patients refused transplant with 9% of patients on the wait list that are less than 75 years old. The June 2024 Transplant Report indicated 52 was the current census, 10% patients received transplant education, 6% of patients had transplant evaluations in process, 21% of patients were ineligible, 6% of patients refused, 6% of patients on the wait list that are less than 75 years old. For April 2024, 4% of patients were tracked out of a census of 48, for May 2024 tracking occurred for 57% of patients out of a census of 46, and for June 2024 52% of patients were tracked out of a census of 52. During an interview on 08/08/2024, beginning at 1:30 PM, Social Worker 1 indicated he/she was responsible for manually entering the transplant QAPI information. Social Worker 1 indicated all active in center hemodialysis patients should have been included on the QAPI monthly data and they were not, and he/she does not know why all patients were not included on the transplant QAPI documentation. 5. A QAPI hepatitis B vaccination report for April 2024 indicated the number of hepatitis B patients with antibodies greater than 10 (protected from hepatitis B) was 31% of 48, the number of patients in the series for hepatitis B vaccines was 3, 33% of 48 patients declined the hepatitis B vaccine, and 0 of 48 patients converted (did not change from being immunized to hepatitis B to being susceptible). The May 2024 QAPI hepatis B vaccination report indicated 33% of 46 patients had antibodies for hepatitis B, 3 patients were in the series of the hepatitis vaccine, 35% of 46 patients declined the vaccine and 0 of 46 converted. The June 2024 QAPI hepatitis B vaccination report indicated 26% of 58 patients had antibodies greater than 10, 3 patients were in the series of the hepatitis vaccine, 28% of 58 patients declined the hepatitis B vaccine and 0 of 58 converted. For April 2024 70% of 48 patients were tracked for hepatitis B, for May 2024 74% of 46 patients were tracked for hepatitis B, and for June 2024 59% of 58 patients were tracked for Hepatitis B. During an interview on 08/08/2024, beginning at 12:55 PM, the Clinical Manager indicated 22 patients were not being tracked for Hepatitis B but should have been included for QAPI.”

“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: 47022 Based on record review and interview, the dialysis facility failed to take actions that resulted in performance improvement and track performance to ensure the improvements were sustained over time in 1 of 1 facility quality assessment performance improvement (QAPI) project for Hepatitis B (liver infection caused by a virus) and kidney (organ that regulates fluid and excretes urine) transplant. Findings include: 1. A revised policy dated 04/23/2021, titled, “Quality Assessment and Performance Improvement,” (QAPI) indicated the dialysis facility would take action that resulted in performance improvement and track performance to ensure sustained performance. The policy indicated the QAPI would develop and implement action plans and evaluate and revise plans that resulted in improvements in care. 2. A QAPI Transplant Report indicated patient kidney transplant tracking for April 2024 was 70% of 48 patients, for May 2024 was 57% of 46 patients, and for June 2024 was 52% of 52 patients. A QAPI Transplant Report indicated patients on the transplant wait list that were 75 years old or under (eligible for transplant) for April 2024 was 5%, for May was 5%, and for June 2024 was 7%. A QAPI Transplant Report indicated for May 2024 11% of patients that were eligible for transplant were on the wait list, and for June 2024 7% of patients that were eligible for for transplant were on the wait list. A QAPI Transplant Report for April, May and June 2024 indicated the goal for transplant would be 25% of eligible patients 75 years old and under would be on the transplant wait list. The QAPI Transplant report for April, May and June 2024 failed to evidence patients eligible for transplant were tracked and performance improvement was sustained. During an interview on 08/08/2024, beginning at 12:55 PM, the social worker indicated the transplant QAPI evaluation should have included tracking of all patients but did not and did not know why all patients were not being tracked. 3. A QAPI hepatitis B vaccination report indicated the percentage of patients tracked for the Hepatitis B vaccine for April 2024 was 70%, for May 2024 was 74% and for June 2024 was 59%. A QAPI hepatitis B vaccination report indicated a low number of patients received the Hepatitis B series, and failed to track all patients to identify the number of patients that required more education regarding the risk of not receiving the Hepatitis B vaccine series or the facility’s interventions to increase the patients protected by a Hepatitis B series vaccine. A review of the End Stage Renal Disease Survey Data Worksheet completed on 08/05/2024 indicated 13 of the current 58 incenter hemodialysis (process toclean the blood of a person whose kidneys don’t work normally) patients had received a complete series of the Hepatitis B vaccine. During an interview on 08/08/2024, beginning at 9:35 AM, the Clinical Manager indicated eduation to patients regarding the Hepatitis vaccine series was done yearly. During an interview on 08/08/2024, beginning at 12:55 PM, the Clinical Manager indicated 22 patients were not being tracked for Hepatitis B but should have been included for QAPI.”