Fmc - Liberty Dialysis - Lafayette II

“CFC-CARE AT HOME CFR(s): 494.100 This Condition is not met as evidenced by: 51751 Based on record review and interview the facility failed to ensure home visits were completed for 2 of 2 home patients reviewed (Patient #9, 10) (See V0589), failed to ensure home medication administration training was completed and documented for 1 of 1 Home hemodialysis (HHD) patient reviewed (Patient #10) (see V0582), and failed to ensure home treatment records were reviewed for 1 of 1 HHD patient reviewed, (Patient #10) (see V0587). The cumulative effect of these systemic problems resulted in the ESRD’s inability to ensure the provision of quality health care in a safe environment for the Conditions for Coverage 42 CFR 494.100 Care at Home with the potential to impact all 24 current home dialysis patients receiving ESRD services from this provider.”

“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: 51751 Based on observation, record review, and interview, the facility staff failed to follow adequate hand hygiene and glove changes to prevent the spread of communicable diseases during 2 of 2 observations. (PCT 4, RN 5) Findings include: 1. According to the “Hand Hygiene” policy (11/06/2023, version 8) all staff must complete hand hygiene using alcohol-based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients and immediately after removing gloves. 2. On 06/24/2025 at 9:56 AM, PCT 4 went from cleaning station 13 to providing patient care at station 14. They removed their gloves but did not perform hand hygiene before putting on clean gloves to care for the patient. During an interview on 06/24/2025 at 10:15 AM, PCT 4 indicated that hand hygiene should be completed between patients and machines, between stations, and between glove changes 3. On 06/27/2025 at 10:56 AM, RN 5 moved from station 25 to station 26. They removed their gloves but failed to perform hand hygiene before putting on new clean gloves. During an interview on 06/27/2024 at 11:20 AM, RN 5 indicated that hand hygiene should be completed between each patient and station. 4. During an interview on 06/27/2025 at 2:18 PM, RN 2 indicated that hand hygiene should be completed prior to applying gloves and after removing gloves and after touching the machine and/or patient. 5. During an interview on 06/27/2025 at 2:39 PM, PCT 8 indicated hand hygiene should be completed when moving between patient and machine, when moving from station to station, and when removing/changing gloves.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure an unstable plan of care (POC) was completed for 1 of 1 Home Hemodialysis (HHD) patient reviewed. (Patient #10) Findings Include: A policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” (07/03/2023, Version 6) indicated unstable patients must be reassessed by the interdisciplinary team (IDT) monthly. Monthly reassessment and any POC updates related to the reason the patient is considered unstable must be documented until the issues have been resolved or the IDT, including the patient, determines that the condition is chronic. Documents titled, “Plan of Care” for Patient #10 dated 03/26/2025, 04/24/2025, and 06/19/2025 were reviewed. The POC dated 03/26/2025 indicated an unstable status related to poor nutrition status, unmanaged anemia, and inadequate dialysis. The POC dated 04/24/2025 indicated a stable status. The POC dated 06/19/2025 indicated an unstable status related to poor nutrition, unmanaged anemia, inadequate dialysis. During an interview on 06/27/2025 at 8:51 AM, RN 1 indicated that an unstable POC is to be completed monthly until deemed stable. Patient #10 has been deemed unstable for several months. She was unaware that the POC dated 04/24/2025 was marked stable and indicated this was an error and Patient #10 should have been marked as unstable and a May POC should have been completed.”

“H-IDT OVERSEES HOME TRAINING CFR(s): 494.100(a) The interdisciplinary team must oversee training of the home dialysis patient, the designated caregiver, or self-dialysis patient before the initiation of home dialysis or self-dialysis (as defined in §494.10) and when the home dialysis caregiver or home dialysis modality changes. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure training of home administration of Venofer (medication used to treat anemia) for 1 of 1 Home Hemodialysis (HHD) patient. (Patient #10) Findings Include: A policy titled, “Home Therapy Venofer Administration” (05/01/2023, Version 4) indicated the home therapies nurse will administer intravenous Venofer to the home hemodialysis patient as ordered by the physician or per algorithm in a monitored setting such as a home therapies program clinic. Dosing and administration of Venofer for HHD patients in the home setting by the home therapies nurse, patient and/or care partner are provided in the CMAB Venofer Algorithm and Venofer Administration for HHD using NxStage policies. These policies were not provided upon request. A document titled, “Patient Transfer” for Patient #10, admission date 04/29/2024, indicated an order for Venofer, self-administer at home, 100 milligrams intravenous push during dialysis three times a week with a start date of 02/24/2025 and end date of 02/23/2026. A review of Patient #10’s treatment sheets dated 04/30/2025 - 06/17/2025 failed to document the home administration of Venofer. During an interview on 06/27/2025 at 8:51 AM, RN 1 indicated being aware that Patient #10 has not been documenting the administration of Venofer in the home and is unsure whether the patient is getting this prescribed medication. She indicated that the medication is not given in the facility due to the order being for home administration only. Education has been provided to Patient #10, but the issue is not resolving. RN 1 indicated a home visit to address this issue has not been completed. A policy for Venofer home administration was requested. During an interview on 06/27/2025 at 10:12 AM, a blank Venofer administration record for January and February was provided for Patient #10. RN 1 indicated she was unsure why this was provided as Patient #10 would not use these forms to document Venofer administration, he/she would document administration via the patient hub on the IPAD. RN 1 was notified that home administration Venofer training records for Patient #10 were requested three times and not provided. She agreed that the document presented three times to surveyors does not include training for Venofer.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure Home Hemodialysis (HHD) records were reviewed for 1 of 1 HHD patients reviewed. (Patient #10) Findings Include: 1. A policy titled, “Patient Monitoring During Hemodialysis Treatment” (02/07/2022, Version 2) indicated vital sign and safety check monitoring frequency will be determined by the home therapy staff and physician be documented as a physician’s order. Frequency shall be reviewed periodically and reassessed when changes in the patient’s condition and/or clinical stability occur. Monitoring frequency shall not exceed hourly intervals for HHD patients with the exception of nocturnal HHD. 2. A policy titled, “Home Therapies Patient Treatment Record Keeping” (09/05/2023, Version 2) indicated Patients and/or care partners will be taught to complete daily record of home dialysis treatments, home medication administration, and educated on importance of maintaining complete and accurate records. Home treatment records will be reviewed by the home therapy RN to identify trends, errors or omissions, and other issues or concerns. 3. A document titled, “Clinical Record View Report” for Patient #10 indicated an order for Home Hemodialysis using NxStage 5 times a week, Monday, Tuesday, Thursday, Friday, and Saturday for 3 hours and 10 minutes. 4.A record review of treatment records dated 04/30/2025 - 06/17/2025 for Patient #10 were reviewed and evidenced the following. 04/30/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/02/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/03/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/07/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/09/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/13/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/20/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/21/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/23/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 05/27/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. Incomplete treatment information between 10:43 PM - 12:13 AM indicating Central Venous Catheter (CVC) pressures, ultrafiltration rate/volume, dialysate rate/volume. 05/29/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete bloodline connector clip use, HHD maintenance information. 20-minute treatment documented from 12:37 AM - 12:57 AM. 06/16/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete CVC access pressure documentation, incomplete dialysate and ultrafiltration rate & volume documentation, incomplete bloodline connector clip use, HHD maintenance information. 06/17/2025: Incomplete pre-intra-post blood pressures/pulse rates/temperature, incomplete CVC access pressure documentation, incomplete dialysate and ultrafiltration rate & volume documentation, incomplete bloodline connector clip use, HHD maintenance information. 5. Missed treatments include the following: 3 missed treatments 05/04/2025 - 05/10/2025 4 missed treatments 05/11/2025 - 05/17/2025 2 missed treatments 05/18/2025 - 05/24/2025 3 missed treatments 05/25/2025 - 05/31/2025 5 missed treatments 06/01/2025 - 06/07/2025 5 missed treatments 06/08/2025 - 06/14/2025 3 missed treatments 06/15/2025 - 06/21/2025 6. During an interview on 06/26/2025 at 12:55 PM, RN 1 indicated that Patient #10 has been non-compliant with completing treatments as ordered and/or not documenting treatment data consistently. She was unaware Patient #10 was not documenting the use of a bloodline connector (device used to prevent separation of blood lines during dialysis) for the Central Venous Catheter. The maintenance section of the flow sheet had not been completed by the patient to include cleaning the blood leak detector, changing the PAK, flushing the drain line, replacing filters, and testing sensors. She was also aware of the inconsistent documentation of vital signs, rates/volumes, and access pressures indicating Patient #10’s lack of documentation has been an ongoing issue. Vitals signs are to be documented every 30 minutes of treatment as well as pre and post treatments. Patient #10 documents via an IPAD during treatment but has intermittent Wi-Fi service issues resulting in the facility being unable to review some of his/her treatment information. The plan was for the patient to bring his/her IPAD into the facility so that treatment data could be downloaded but has not been done. RN1 indicated that home visits for Patient #10 have not been completed to address any of these concerns. The review of home documents are completed in the Patient Care Hub, and she would provide this information to the surveyors. No further information was received.”

“H-MONITOR HOME ADAPT;HOME VISIT=POC CFR(s): 494.100(c)(1)(i) Services include, but are not limited to, the following: (i) Periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure home visits were completed for 2 of 2 home patients reviewed. (Patient #9, 10) Findings Include: 1. A policy titled, “Home Visits for Home Dialysis Patients” (07/03/2024, Version 4) indicated a home visit is recommended annually to ensure the continued safety of the home environment, using the Patient Home Visit Checklist and/or the Patient Home Environment Evaluation. A home visit shall be conducted whenever a problem is identified with either patient health or equipment that could be related to the patient’s home treatment. The number, timing and frequency of home visits will be based on individual patient need as indicated in the patient’s plan of care. 2. A document titled, “Patient Transfer” dated 06/26/2025 indicated an admission date of 04/29/2024 for Patient #10. A document titled, “Patient Home Environment Evaluation” dated 04/23/2024 indicated an initial home visit was completed by a home nurse to assess the home environment prior to the start of home hemodialysis treatment for Patient #10. No further home visits were provided. Documents titled, “Plan of Care” dated 03/26/2025, 04/24/2025, and 06/19/2025 failed to include the number, timing, and frequency home visits should occur for Patient #10. During an interview on 06/26/2025 at 12:55 PM, RN 1 indicated that Patient #10 has ongoing concerns regarding treatment adherence, documentation of treatments to include HHD safety checks, blood pressures, weights, and medication administration in the home. Patient #10 has been deemed unstable as of March 2025, and a patient non-adherent contract has been initiated. During an interview on 06/27/2025 at 8:51 AM, RN 1 indicated Patient #10 has not been documenting Venofer (intravenous medication used to treat anemia) administration, the use of blood connector clip (device used to prevent the separation of dialysis lines during treatment), or dialysis machine maintenance. He/she is not meeting Kt/v (measurement of how well dialysis is working) month to month due to shortened/skipped treatments. RN 1 indicated that home visits are to be completed annually with exceptions for additional home visits due after a hospitalization stay and identified patient and/or caretaker concerns. 3. A document titled, “Patient Transfer” dated 06/26/2025 indicated an admission date of 09/26/2023 for Patient #9. A document titled, “RN Home Visit - Initial and Skills Validation” dated 10/26/2023 indicated an initial home visit was completed by a home nurse to assess the start at home treatment for Patient #9. No further home visits were provided. During an interview on 06/27/2025 at 8:51 AM, RN 1 indicated that home visits are to be completed annually. Exceptions requiring additional home visits include post hospitalizations and patient/caregiver concerns or issues identified. A home visit to address Patient #9’s incomplete documentation of treatment records has not been completed. RN 1 agreed that the treatment sheet dated 03/30/2025 - 06/15/2025 intermittently failed to document daily weights, blood pressures, pulses, temperatures, amount of fluid pulled each exchange, drain color, clarity of fluid, fibrin present, and daily exit site care.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 51751 Based on record review and interview, the facility failed to ensure Tuberculosis (TB) testing was administered upon hire for 4 of 6 personnel files reviewed. (PCT 3, 9, 10, and CM) Findings include: 1. According to the “Medical Evaluation Requirements for New Hires/ Rehires” policy (06/09/2021, version 2), an Employee Baseline Tuberculosis (TB) assessment Form and TB risk Assessment Questionnaire must be completed by all applicable new hires. A TB skin test is required upon hire using the two-step tuberculin skin test (TST) method. If a new employee has a documented baseline TST result within the previous 12 months, a single TST can be administered as this additional TST represents the second stage of the two-step testing, If an employee provides Interferon-Gamma Release Assay (IGRA) results, these results can be accepted upon hire. 2. A personnel record review for PCT 3, date of hire 12/23/2024, evidenced a one-step TST administered by the facility on 12/09/2024. The facility failed to administer a second step TST or provide evidence that PCT 3 had a test in the previous 12 months. 3. A personnel record review for PCT 9, date of hire 03/13/2025, failed to evidence an initial two-step TST upon hire, a TST within the past 12 months, or an IGRA negative result excluding the diagnosis of TB. 4. A personnel record review for PCT 10, date of hire 04/07/2025, failed to evidence an initial two-step TST upon hire, a TST within the past 12 months, or an IGRA negative result excluding the diagnosis of TB. 5. A personnel record review for the CM, date of hire 05/27/2025, failed to evidence an initial two-step TST upon hire, a TST within the past 12 months, or an IGRA negative result excluding the diagnosis of TB. 6. During an interview on 06/27/2025 at 12:52 PM, the CM indicated that she did not receive a TB test when she was rehired, she was given a risk assessment since the area is considered low risk. 7. During an interview on 06/27/2025 at 2:18 PM, RN 2 indicated that TB testing is required upon hire, but she would have to review the policy to know the exact requirements. 8. During an interview on 06/27/2025 at 2:39 PM, PCT 8 indicated that a two-step TST is administered upon hire.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 51751 Based on observation, record review, and interview, the medical director failed to ensure staff followed policy and procedures to include expired supply monitoring for 1 of 1 facility reviewed. Findings include: 1. According to the “Storage of Supplies” policy (04/05/2021, version 2), supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date. 2. During an observation of the in-center treatment floor on 06/23/2025 at 9:51 AM, 4 25-gauge x 5/8-inch safety needles found in the medication storage cabinet at the second nurses station expired 01/31/2025. 3. During an observation of the in-center treatment floor on 06/23/2025 at 10:00 AM, 99 red top lab tubes were found in the supply cart expired 05/31/2025. 4. During an observation of the crash cart on 06/23/2025 at 10:04 AM, a standard nasal canula found expired 06/09/2022, 2 7ft oxygen tubing expired 08/20/2024, and 1 7ft oxygen tubing expired 3/11/2025. 5. During an observation of the in-center treatment floor on 06/23/2025 at 10:20 AM, 44 25-gauge x 5/8-inch safety needles found in the medication storage cabinet in the third nurses station expired 01/31/2025. 6. During an observation of the Home Department on 06/23/2025 at 11:18 AM, 1 bottle of Residual Chlorine reagent test strips (strips used to check chlorine levels) were found at the dirty sink and expired 03/31/2025. 7. During an interview on 06/23/2025 at 9:54 AM, RN 3 indicated she was unsure who oversaw checking for expired supplies. 8. During an interview on 06/23/2025 at 11:22 AM, PCT 1 indicated that everyone oversees monitoring of expired supplies and supplies should be checked by staff prior to using. 9. During an interview on 06/27/2025 at 2:18 PM, RN 2 indicated that all staff are held responsible for monitoring for expired supplies. 10. During an interview on 06/27/2025 at 2:39 PM, PCT 8 indicated that she does the supply ordering and tries to monitor supplies monthly for expiration but overall, it’s everyone’s responsibility.”

“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: 51751 Based on record review and interview, the facility failed to obtain the patient’s early termination of treatment documentation in 3 of 8 records reviewed. (Patient #3, 6, 8) Findings include: 1. A policy titled, “Early Termination or Arriving Late for Treatment” (06/18/2025, Version 4) indicated, the RN will evaluate the patient and discuss the reasons for requesting to terminate treatment early. The RN must document the rationale and reinforce the consequences of not receiving the entire prescribed treatment. The RN is responsible to notify the provider, and document on the “AMA” or Against Medical Advice form. 2. A clinical record review for Patient #3 indicated a physician ordered treatment time of 4 hours. A treatment sheet dated 06/07/2025 for Patient #3 indicated a treatment time of 2 hours and 57 minutes. The facility failed to complete the AMA document requiring patient education, patient signature, and staff signature. A treatment sheet dated 06/19/2025 for Patient #3 indicated a treatment time of 3 hours and 10 minutes. The facility failed to complete the AMA document requiring patient education, patient signature, and staff signature. A treatment sheet dated 06/21/2025 for Patient #3 indicated a treatment time of 3 hours and 5 minutes. The facility failed to complete the AMA document requiring patient education, patient signature, and staff signature. 3. A clinical record review for Patient #6 indicated a physician ordered treatment time of 3 hours and 15 minutes. A treatment sheet dated 06/11/2025 for Patient #6 indicated a treatment time of 2 hours and 14 minutes. The facility failed to complete the AMA document requiring patient education and both patient and staff signatures. A treatment sheet dated 06/16/2025 for Patient #6 indicated a treatment time of 2 hours and 54 minutes. The facility failed to complete the AMA document requiring patient education and both patient and staff signatures. A treatment sheet dated 06/21/2025 for Patient #6 indicated a treatment time of 2 hours and 5 minutes. The facility failed to complete the AMA document requiring patient education and both patient and staff signatures. 4. A clinical record review for Patient #8 indicated a physician ordered treatment time of 3 hours and 15 minutes. A treatment sheet dated 06/02/2025 for Patient #8 indicated a treatment time of 2 hours and 31 minutes. The facility failed to complete the AMA document requiring patient education and both patient and staff signatures. A treatment sheet dated 06/09/2025 for Patient #8 indicated a treatment time of 2 hours and 16 minutes. The facility failed to complete the AMA document requiring patient education and both patient and staff signatures. A treatment sheet dated 06/23/2025 for Patient #8 indicated a treatment time of 2 hours and 20 minutes. The facility failed to complete the AMA document requiring patient education and both patient and staff signatures. 5. During an interview on 06/26/2025 at 9:46 AM, the CM indicated the expectation regarding shortened treatments by patients is to educate the patient and ensure the patient signs the AMA document. If the patient refuses to sign the document, two staff members are to sign, documenting refusal by patient. Due to inconsistent staffing, AMA’s may not be completed or documented. 6. During an interview on 06/27/2025 at 2:18 PM, RN 2 indicated that staff are to educate patient on terminating treatment early and an AMA document must be signed if a patient shortens treatment. If the patient refuses to sign the document, two staff members must sign the document. 7. During an interview on 06/27/2025 at 2:39 PM, PCT 8 indicated the patient is educated on shortening treatment, the nurse is notified, and the patient signs the AMA document. If the patient refuses to sign the document, then two staff members must sign.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the End Stage Renal Disease (ESRD) facility failed to ensure all items taken into the in-center hemodialysis (ICHD) station were disposed of, dedicated as single-patient use only, or cleaned and disinfected before being taken to a common clean area for 1 of 3 periods of treatment floor observations performed on 02/05/24 (Patient #44). Findings include: The review of facility policy #47806 titled “Cleaning and Disinfecting the Dialysis Station,” dated 9/05/23, indicated all non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or an EPA-registered disinfectant before being removed from the dialysis station. During observations of the ICHD treatment floor on 02/05/24 between 2:05 PM to 3:50 PM, Patient Care Technician (PCT) 14 was observed in Station #6 with Patient #44 beginning at 2:50 PM. The technician directed Patient #44 to stand at the side of his/her treatment chair to obtain a post-treatment standing blood pressure. While Patient stood, PCT 14 left the station, obtained a biohazard bin from the nurse’s station, and brought the biohazard bin into Station #6. PCT 14 then disconnected Patient’s dialysis tubing from the dialysis machine and placed the tubing into the biohazard bin. The technician walked Patient #44 to the scale, returned to Station #6 to enter Patient’s post-treatment weight, then took the biohazard bin to the outside of Station #4, the facility’s isolation room. PCT 14 failed to clean the biohazard bin prior to removing it from Station #6. During an interview with the Administrator and Alternate Administrator on 02/06/24 beginning at 3:45 PM, the Alternate Administrator reported the biohazard bin should not be brought into the ICHD station.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the End Stage Renal Disease (ESRD) failed to ensure the dialysate pH and conductivity for all in-center hemodialysis (ICHD) patients was verified according to facility policy for 1 of 2 dialysate pH and conductivity verifications observed (Patient #46). Findings include: The review of facility policy #25912 titled “Checking Conductivity and pH of Final Dialysate,” dated 04/11/22, indicated the Potential of Hydrogen (pH, the measurement which indicates the level of acidity or alkalinity in a solution) and conductivity (measurement of the amount of sodium in dialysate) must be tested prior to each patient’s dialysis treatment. For ICHD patients, 2 staff members were to verify the pH and conductivity prior to beginning the patient’s treatment. During an observation on 02/05/24 beginning at 3:23 PM at Station #4, Patient Care Technician (PCT) 14 was observed preparing the dialysis machine for Patient #46’s ICHD treatment. The technician obtained a dialysate sample from the dialysis machine, took the sample to a dirty sink used to test dialysate, and obtained the sample’s pH and conductivity using a D6 meter. PCT 14 returned to Station #14, performed site care and connected the dialysis tubing to Patient’s central venous catheter (long IV placed into a large vein), Registered Nurse (RN) 1 entered the station to verify Patient’s dialysis settings, and Patient #46’s treatment was initiated. During an interview with PCT 14 on 02/05/24 beginning at 5:12 PM, the technician reported he/she did not have another employee verify the pH and/or conductivity for Patient #46 prior to initiating Patient’s dialysis. During an interview with the Administrator and Alternate Administrator on 02/06/24 beginning at 3:45 PM, the Alternate Administrator reported 2 employees should verify the dialysate pH and conductivity prior to initiating a patient’s treatment.”

“PR-INFORMED OF INTERNAL GRIEVANCE PROCESS CFR(s): 494.70(a)(14) The patient has the right to- (14) Be informed of the facility’s internal grievance process; This Standard is not met as evidenced by: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) failed to follow its interval grievance process and ensure all patients were not retaliated against after reporting a grievance for 4 of 13 complaints reviewed (Patients #33, 37, and 61), which had the potential to affect all facility patients. Findings include: 1. The review of the facility policy titled “Patient Grievance Procedure,” dated 4/04/14, indicated the clinic manager was to meet with the complainant within 5 business days to “acknowledge, investigate and address the grievance.” The medical social worker (MSW) and other staff could assist with “assessing and resolving” grievances “as appropriate.” The clinic manager was to inform the complainant “when a resolution is attained.” 2. The review of the facility’s grievance log indicated Patient #37 reported a grievance to MSW 1 on 12/06/23. The patient reported Patient Care Technician (PCT) 5’s behavior on the in-center hemodialysis (ICHD) treatment floor, stating the technician was “running around fast and complaining all the time.” Patient #37 reported PCT 5 was “way too rough” when he/she cannulated Patient and caused Patient pain. Patient #37 reported PCT 5 told Patient that the procedure “didn’t hurt that bad.” Patient requested PCT 5 no longer work with him/her. The documented grievance resolution indicated PCT 5 was re-educated on cannulation policies and procedures. The review of the facility’s grievance log indicated Patient #37 reported a second grievance to MSW 1 on 01/08/24 regarding care provided by PCT 5. The patient reported the technician was continuing to cannulate him/her and questioned if MSW 1 had reported the previous grievance to the clinic manager. Patient #37 reported after he/she reported the initial grievance on 12/06/23, PCT 5 approached the patient and asked, “why don’t you want me to stick you, what’s wrong with me?” The patient reported after he/she was confronted by PCT 5, the patient did not feel comfortable telling the technician no, and PCT 5 cannulated the patient. Patient #37 reported he/she now had a “red bruise that hurts and won’t go away.” MSW 1 documented he/she informed PCT 5 that Patient #37 requested he/she no longer perform their cannulation. The review of the facility’s grievance log indicated Patient #33’s family member reported a grievance to MSW 1 on 12/06/23. The family member reported Patient #33 had been started on a new medication without the family member’s permission, as the family member was the patient’s medical power of attorney and Patient had short term memory loss. The grievance log failed to evidence an investigation was conducted by the facility and the grievance’s resolution. The review of the facility’s grievance log indicated Patient #61 reported a grievance to PCT 3 on 01/15/24. Patient reported he/she was not notified of a change to his/her ICHD treatment time. The grievance log failed to evidence an investigation was conducted by the facility and the grievance’s resolution. During an interview with the Administrator and Alternate Administrator on 12/07/24 beginning at 3:25 PM, the Alternate Administrator reported he/she was unsure which employee documented the resolution to Patient #37’s grievance on 12/06/23, but it was usually documented by MSW 1. The Alternate Administrator reported he/she met with PCT 5 after Patient #37’s second complaint and reeducated the employee on the appropriateness of speaking with a patient after a grievance was filed against him/her. The Alternate Administrator reported the facility was a “no retaliation company.” When queried on where the re-education was documented, Alternate Administrator reported this was not documented within the grievance log nor the employee’s personnel file. The Alternate Administrator was unsure of the reason there was no resolution documented for the grievances involving Patients #33 and #61. 3. During an interview with MSW Manager 2 on 02/07/24 beginning at 2:10 PM, the manager reported MSW 1 was unavailable for interview. MSW Manager 2 initially reported MSW 1 was responsible for taking grievances, investigating, and documenting a resolution, then later in the interview stated it was the clinic manager’s responsibility for investigating and documenting the grievance resolution.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) facility failed to ensure the advanced care provider providing ESRD care addressed all patient concerns for 1 of 1 in-center hemodialysis patient records reviewed of a patient reporting potential side effects of blood pressure medication (Patient #48). Findings include: The review of the medical journal article titled “Erectile dysfunction in hemodialysis: A systematic review,” dated 12/06/12 and obtained from www.ncbi.nlm.nih.gov, indicated the prevalence of erectile dysfunction (ED, the inability to obtain and/or maintain an erection) among male ESRD patients was between “20% - 87.7%”. The journal article indicated the use of antihypertensive medications (lower blood pressure) in ESRD patients was a potential cause of ED, as several of these medications were “known to cause sexual problems or exacerbate existing problems.” The review of Patient #48’s clinical record indicated the patient’s current medications included the following medications used to treat an elevated blood pressure and/or heart rate: a. Minoxidil, which was entered into the record on 09/22/22 b. Hydralazine, which was entered into the record on 09/22/22 c. Clonidine, which was entered into the record on 09/22/22 d. Carvedilol, which was entered into the record on 09/22/22 e. Amlodipine, which was entered into the record on 11/03/22 f. Lisinopril, which was entered into the record on 03/26/20 Patient #48’s clinical record included a plan of care last updated 01/26/24. The plan of care indicated the goal “achieve BP [blood pressure] control as specified by the patient’s physician” was marked as met on 11/21/23. The record included a Provider Rounding Note, dated 12/14/23, by Physician Assistant (PA) 3. The note indicated Patient #48 reported ED to PA 3 during the rounding visit. In response to the patient’s report, PA 3 documented the facility would “reevaluate” the patient’s blood pressure medications. The record included Provider Rounding Notes dated 12/16/23 and 01/30/24 by ESRD Physician 2 and notes dated 12/19/24, 01/27/24, and 02/01/24 by PA 3. The provider rounding notes failed to evidence the ESRD advanced care practitioners followed up with Patient #48 regarding his/her reported ED nor did the advanced care practitioners attempt to adjust or discontinue Patient #48’s antihypertensive medication(s) as indicated during the note on 12/14/23. During an interview with Patient #48 on 02/06/24 beginning at 8:20 AM, Patient reported he/she had reported issues with ED to PA 3 “before Christmas” and asked the physician assistant to speak with ESRD Physician 2, however Patient had not heard anything further regarding his complaint. Patient reported since reporting this issue, he/she had seen the physician assistant on the treatment floor and PA 3 had “smiled and waved” but did not speak with the patient. Patient #48 reported because he/she did not hear anything further from PA 3 nor ESRD Physician 2 regarding his/her ED, Patient stopped his/her blood pressure medications and the issues with ED resolved; Patient could not recall which medications he/she stopped. During an interview with PA 3 on 02/07/24 beginning at 11:58 AM, the PA reported the facility was “in process” of weaning Patient #48’s blood pressure medication, however no adjustments had been made. When queried on the reason no adjustment had been made to Patient #48’s medication(s), the physician assistant reported when he/she rounded on Patient after the initial report of ED, Patient #48 was “generally” doing well and had no complaints. PA 3 also reported he/she wanted to discuss with Patient #48 the “process” of weaning medications and monitor Patient’s blood pressure and heart rate, but this had not yet occurred. PA 3 thought he/she discussed Patient’s ED and potential to wean the blood pressure medication(s) with ESRD Physician 2. During an interview with ESRD Physician 2 on 02/07/24 beginning at 12:49 PM, the physician reported he/she did not recall Patient #48 nor PA 3 reporting issues with ED. The physician stated he/she would not adjust a patient’s blood pressure medication for a complaint of ED unless the patient “persistently or consistently” complained of this issue.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 42617 Based on observation, record review, and interview, the End Stage Renal Disease (ESRD) facility failed to ensure staff followed its mitigation policy and procedures for in-center hemodialysis patients identified as having bed bugs (See V111), failed to ensure all staff followed hand hygiene and personal protective equipment (PPE) policies and best practices (See V113), failed to ensure all in-center hemodialysis (ICHD) hand washing sinks had soap available and a supply of paper towels protected from contamination (See V114), failed to ensure all staff followed facility procedures and best practices when disinfecting the dialysis station after ICHD treatment (See V122), failed to ensure all staff performing direct patient care received a 2-step tuberculosis (TB, an infectious respiratory disease) test upon hire (See V142), and failed to ensure all staff cleaned the top of a medication vial prior to drawing up medications (See V143). The scope of the finding evidenced Liberty Dialysis Lafayette II was unable to provide adequate infection control measures, which resulted in Liberty Dialysis Lafayette II being found out of compliance with Condition for Compliance 494.30 Infection control.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 42617 Based on observation, record review, and interview, the End Stage Renal Disease (ESRD) facility failed to ensure a test for total chlorine of the in-center hemodialysis (ICHD) product water was performed and documented, according to facility policy, prior to the first patient treatment and every 4 hours afterwards by staff previously tested for color blindness (see tag V196). The scope and severity of the findings evidenced Liberty Dialysis Lafayette II was unable to ensure ICHD product water being used for hemodialysis was within total chlorine limits, which resulted in Liberty Dialysis Lafayette II being found of out of compliance with Condition for Compliance 42 CFR 494.40 Water and dialysate quality.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) facility failed to ensure the patient’s estimated dry weight was adjusted per facility algotiyhim, failed to ensure the in-center hemodialysis (ICHD) patients’ vital signs were obtained according to the facility, failed to ensure the Registered Nurse (RN) and/or MD was notified for blood pressure or heart rate being out of parameters, and failed to ensure the RN re-assessed a patient’s abnormal lung sounds (See V543); failed to administer medications for the treatment of anemia (a condition where the number of red blood cells is decreased) according to its anemia management protocol (See V547), failed to ensure the patient signed the completed plan of care (See V556); and failed to ensure the unstable patient’s plan of care was updated according to facility policy (See V559). The scope and severity of the findings evidenced Liberty Dialysis Lafayette II was unable implement and maintain the patient’s plan of care, which resulted in Liberty Dialysis Lafayette II being found out of compliance with Condition for Coverage 42 CFR 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: 42617 Based on observation, record review, and interview, the End Stage Renal Dialysis (ESRD) facility failed to follow its mitigation policies and procedures for in-center hemodialysis patients identified as having bed bugs, which had the potential to affect all facility patients and staff, for 1 of 1 observation of a patient identified with bed bags. Findings include: 1. A review of the policy titled “Bed Bug Control Policy,” revised 12/22, indicated when a patient was identified as having bed bugs, the facility would place the patient in a “dialysis chair away from other patients to mitigate the risk of transferring bed bugs to others.” 2. During an observation of the in-center hemodialysis treatment floor on 12/18/23 at 11:33 AM, Patient #6 was observed receiving treatment at Station #11, which was positioned next to the entrance/exit to the treatment pod. Patient #30 was observed receiving treatment at Station #10, which was the station directly to the left of Station #11. 3. During an interview with Registered Nurse 1 on 12/18/23 beginning at 4:10 PM, the nurse reported Patient #6 had bed bugs. 4. During an interview with the Administrator and Interim Clinic Manager 3 on 12/21/23 beginning at 4:49 PM, the Administrator reported the facility had moved Patient #6 from the “middle” of the treatment pod to the “outer row.” The Administrator and Interim Clinic Manager 3 were unable to state a reason for repositioning Patient #6 in the station directly next to the treatment pod’s entrance and exit.”

“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: 42617 Based on observation, record review, and interview, the End Stage Renal Disease (ESRD) facility failed to ensure all staff followed hand hygiene and personal protective equipment (PPE) policies and best practices for 8 of 12 employees observed providing direct patient care (Registered Nurse (RN) 1, RN 2, RN 3, Patient Care Technician (PCT) 2, PCT 4, PCT 5, Medical Director, Home Therapy Nurse 5). Findings include: 1. A review of facility policy #47664 titled “Hand Hygiene,” dated 11/06/23, indicated hand hygiene should be performed before and after direct contact with patients, when entering and leaving the treatment area, and immediately after removing gloves. The policy also indicated when performing hand hygiene by washing hands with soap and water, the procedure should last “40 - 60 seconds.” 2. A review of facility policy #47663 titled “Personal Protective Equipment,” dated 11/06/23, indicated staff should wear PPE including a “full-face shield ... fluid-resistant gowns, and gloves” when there was a potential for exposure to blood or other potentially infectious materials. 3. A review of facility policy #45640 titled “Termination of Treatment Using a Central Venous Catheter [CVC] and Optiflux Single Use Ebeam Dialyzer,” dated 02/07/22, indicated when preparing to disconnect a patient’s CVC from dialysis, the employee should perform hand hygiene, don gloves, and “ensure that a clean under pad is below the catheter ....” 4. During an in-center hemodialysis (ICHD) observation on 12/18/23 beginning at 11:55 AM at Station #2, Registered Nurse (RN) 2 was observed disconnecting Patient #12’s dialysis lines from their central venous catheter. The nurse placed a clean field under the patient’s CVC ports with ungloved hands. 5. During an ICHD observation on 12/18/23 at 12:33 PM, Patient Care Technician (PCT) 4 was observed leaving Station #11, removed their gloves and performed hand hygiene, adjusted their hair, donned new gloves, then entered Station #4. The PCT failed to perform hand hygiene prior to donning gloves. 6. During an ICHD observation on 12/18/23 at 2:32 PM, RN 1 was observed leaving Station #17, removed their gloves and performed hand hygiene, obtained supplies, adjusted their hair, then donned new gloves and re-entered Station #17. The nurse failed to perform hand hygiene prior to donning gloves. 7. During an ICHD observation on 12/18/23 at 2:34 PM at Station #16, PCT 2 was holding pressure to Patient #15’s arteriovenous fistula site after decannulating. RN 2 entered Station #16 to speak with PCT 2 without a gown or face shield. The nurse left the station, obtained supplies, and returned to Station #16 with a gown over their torso but the sleeves of the gown hanging down by their side. RN 2 put their arms in the gown’s sleeves while in Station #16. 8. During an ICHD observation on 12/18/23 at 2:50 PM at Station #9, PCT 4 was observed leaving the station, removing their gloves, repositioned their face shield, then performed hand hygiene. The technician failed to perform hand hygiene immediately after removing their gloves. 9. During an ICHD observation on 12/18/23 at 3:35 PM, PCT 4 was observed leaving Station #13, removed their gloves, performed hand hygiene, repositioned their pants, donned gloves, then entered Station #10. The technician failed to perform hand hygiene prior to donning new gloves. 10. During an ICHD observation on 12/19/23 at 1:22 PM, RN 3 was observed washing their hands at a handwashing station. The nurse scrubbed their hands for 15 seconds. 11. During an ICHD observation on 12/19/23 at 1:40 PM at Station #3, PCT 2 was observed removing their gown and gloves in the station. 12. During an ICHD observation on 12/19/23 at 1:48 PM at Station #9, PCT 5 was observed providing patient care without a face shield. 13. During a home peritoneal dialysis (PD) clinic visit observation with Patient #9 on 12/21/23 beginning at 1:55 PM, Home Therapy Nurse 5 was observed washing their hands prior to drawing the patient’s blood. The nurse applied soap, scrubbed their hands for 2 seconds, then scrubbed their hands under running water for 13 seconds. Later during the clinic visit, the Medical Director was observed washing their hands prior to their assessment of Patient #9. The physician scrubbed their hands for 4 seconds. 14. During an interview with the Administrator and Interim Clinic Manager 3 on 12/19/23 beginning at 4:46 PM, the clinic manager reported staff should wear a gown, mask, and face shield in an ICHD station and should not remove their gown or mask while in the station. The clinic manager also reported staff should wear gloves when placing a barrier under a CVC. 15. During an interview with the Administrator and Interim Clinic Manager 3 on 12/21/23 at 4:15 PM, the administrative staff indicated when washing hands, staff should scrub their hands with soap for the duration of the “happy birthday” song. During a follow-up interview with the Administrator and Interim Clinic Manager 3 on 12/21/23 beginning at 4:49 PM, the Administrator reported the facility’s policy did not state staff have to perform hand hygiene after touching their hair or pants. The Administrator also reported staff should wash their hands for 40-60 seconds.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the End Stage Renal Disease (ESRD) facility failed to ensure all in-center hemodialysis (ICHD) hand washing sinks had soap available and a supply of paper towels protected from contamination, which had the potential to affect all ICHD patients and employees. Findings include: 1. A review of the facility policy #47664 titled “Hand Hygiene,” dated 11/06/2023, indicated “soap and a supply of paper towels protected from contamination” should be available at every hand washing sink. 2. During an observation of the ICHD treatment floor on 12/18/2023 at 12:50 PM, a hand washing station was observed with no soap available. During an interview with Patient Care Technician (PCT) 1 on 12/18/23 at 12:51 PM, the technician confirmed the sink observed was a handwashing station and did not have soap available. 3. During an observation of the ICHD treatment floor on 12/18/2023 at 12:53 PM, a hand washing station was observed with a roll of paper towels sitting on the counter next to the sink. The paper towel dispenser next to the sink was empty. 4. During an observation on the ICHD treatment floor on 12/19/2023 at 2:08 PM, a hand washing station was observed with a roll of paper towels sitting on the counter next to the sink. The paper towel dispenser next to the sink was empty. 5. During an interview with the Alternate Administrator on 12/22/2023 beginning at 3:50 PM, the Alternate Administrator stated paper towels should be stored “off to the side” of the handwashing sink. The Alternate Administrator was unsure how the facility would prevent contamination of the paper towels when they were sitting on the counter.”

“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: 42617 Based on observation, record review, and interview, the End Stage Renal Dialysis (ESRD) facility failed to ensure all staff followed facility procedures and best practices when disinfecting the dialysis station after in-center hemodialysis treatment for 2 of 3 station cleaning observations (Patient Care Technician (PCT) 2, 3). Findings include: 1. A review of the facility policy #47806 titled “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, indicated when disinfecting a dialysis station, staff should open the side panels of a treatment chair to access all surfaces. The policy also indicated staff should allow all surfaces to air dry. 2. During an observation on 12/18/23 beginning at 3:07 PM, Patient Care Technician (PCT) 2 was observed disinfecting Station #17 after the patient had left treatment. The technician opened the sides of the treatment chair, wiped the sides with a bleach wipe, then immediately closed the sides. PCT 2 failed to allow the chair sides to dry prior to closing. 3. During an observation on 12/19/23 beginning at 1:10 PM, PCT 3 was observed cleaning Station #20 after the patient had left treatment. The technician used the same bleach wipe to clean the dialysis machine and the treatment chair. When cleaning the treatment chair, PCT 3 opened the chair’s side panels, wiped them with a bleach wipe, then immediately closed the sides. PCT 3 failed to change bleach wipes in between cleaning the dialysis machine and treatment chair and failed to allow the chair’s side panels to dry prior to closing. During an interview with PCT 3 on 12/20/23 beginning at 9:45 AM, the technician reported when disinfecting the dialysis machine and IV pole to the treatment chair, he/she would flip the bleach wipe over but not change wipes. 4. During an interview with the Administrator and Interim Clinic Manager 3 on 12/21/23 beginning at 4:15 PM, the clinic manager reported when disinfecting a dialysis station, the clinic manager reported staff should use a separate bleach wipe when moving from the dialysis machine to the treatment chair. During a follow up interview with the Administrator and Interim Clinic Manager 3 on 12/21/23 beginning at 4:49 PM, the Administrator reported when disinfecting a dialysis station, the treatment chair’s side panels should be left open long enough to dry.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) failed to ensure all staff performing direct patient care received a 2-step tuberculosis (TB, an infectious respiratory disease) test upon hire for 5 of 8 employees hired in 2023, which had the potential to affect all in-center hemodialysis patients (Employees A, C, D, E, F). Findings include: 1. A review of facility policy titled “Employee Tuberculosis Testing,” dated 04/05/21, indicated a Tuberculosis Risk Assessment Employee Questionnaire (TB-RAQ) and a two-step tuberculin skin test (TST, a screening test for TB, which is done by injecting an inactive form of TB under the skin on 2 separate occasions and assessed for a reaction) would be performed on hire. 2. A review of the facility’s personnel files evidenced the following: a. Employee E’s hire date was 03/06/23. A TB-RAQ was completed on 12/19/23. The file failed to evidence a two-step TST was completed upon hire. b. Employee D’s hire date was 04/03/23. An “Employee Tuberculosis Baseline Risk Assessment” was completed on 12/18/23. The file failed to evidence a two-step TST was completed upon hire. c. Employee F’s hire date was 05/01/23. The employee’s first TST was administered on 05/03/23 and read on 05/05/23. The file failed to evidence a second TST was completed. d. Employee A’s hire date was 05/30/23. A TB-RAQ was completed on 12/19/23. The file failed to evidence a two-step TST was completed upon hire. e. Employee C’s hire date was 07/24/23. A TB-RAQ was completed on 12/18/23. The file failed to evidence a two-step TST was completed upon hire. 3. During an interview with the Alternate Administrator on 12/28/23 beginning at 2:02 PM, the Alternate Administrator reported the facility was classified as “low risk” for TB infections, therefore new employees were to complete a TB-RAQ upon hire. The Alternate Administrator reported when compiling the personnel files for the survey, he/she could not find of evidence the TB screening questionnaire was completed upon hire for Employee A, C, D, E, and F. The Alternate Administrator also reported the facility had not adapted a national standard for TB screening of employees.”

“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: 42617 Based on observation, record review, and interview, the End Stage Renal Disease (ESRD) facility failed to ensure all staff cleaned the top of a medication vial prior to drawing up medications for 1 of 1 observations of facility staff preparing and administering intravenous (IV) medications (Registered Nurse (RN) 2). Findings include: A review of facility procedure #47577 titled “Medication Preparation and Administration Procedure,” dated 09/05/23, indicated when drawing up a medication from a vial, staff should remove the protective cap from the vial and “wipe [the] rubber stopper with [an] alcohol prep pad ....” During an observation on 12/19/23 beginning at 1:33 PM, Registered Nurse (RN) 2 was observed preparing the intravenous (IV) medications Hectoral (medication used to treat an overactive parathyroid gland) and Benadryl (medication used to treat itching) for Patient #7. The nurse failed to wipe top of the medication vials prior to injecting a needle to draw up the medication. During an interview with RN 2 on 12/19/23 beginning at 4:15 PM, the nurse reported the Hectoral medication vial used for Patient #7 was a multi-use vial and the Benadryl medication vial used for Patient #7 was a single use vial. The nurse stated they had opened the Benadryl vial earlier in the day but had not used it. The nurse reported the top of the medication vial should be cleaned prior to drawing up the medication. During an interview with the Administrator and Interim Clinic Manager 3 on 12/19/23 beginning at 4:46 PM, the clinic manager reported staff should wipe the top of a medication vial with an alcohol pad prior to drawing up the medication.”

“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: 42617 Based on observation, record review, and interview, the End Stage Renal Disease (ESRD) facility failed to ensure a test for total chlorine of the in-center hemodialysis (ICHD) product water was performed and documented, according to facility policy, prior to the first patient treatment and every 4 hours afterwards by staff tested for color blindness, which had the potential to affect all in-center hemodialysis patients. Findings include: 1. A review of the policy titled “Color Blindness Testing,” dated 01/23/19, indicated direct patient care positions “require the ability to interpret or distinguish color when performing water and/or other quality tests ... People who suffer from color blindness, may not be able to distinguish between certain colors used in water” testing. The policy indicated color blindness testing should be performed on all staff working in a direct patient care position. 2. A review of procedure titled “Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips Procedure,” dated 04/05/21, indicated when performing a total chlorine test, staff would dip the test strip in the sample water, remove the strip, then wait 20 seconds prior to reading the result to allow the test strip color to develop. The results would then be documented in an “electronic documentation system or approved paper log.” 3. During an ICHD treatment floor observation on 12/19/23 beginning at 2:52 PM, Patient Care Technician (PCT) 5 and Registered Nurse (RN) 3 were observed performing a total chlorine test of the ICHD product water. The employees read the results of the test 12 seconds after removing the test strip from the sample. During an interview with the Administrator and Interim Clinic Manager 3 on 12/19/23 beginning at 4:46 PM, the clinic manager reported staff should wait 20 seconds to read the results after removing the strip from the product sample. 4. A review of the facility’s personnel files evidenced the following: a. PCT 1’s hire date was 03/06/23. A color blindness test was completed on 12/18/23. b. PCT 5’s hire date was 03/06/23. A color blindness test was completed on 12/19/23. c. PCT 2’s hire date was 04/03/23. A color blindness test was completed on 12/18/23. d. RN 3’s hire date was 05/30/23. A color blindness test was completed on 12/19/23. e. PCT 7’s hire date was 07/24/23. A color blindness test was completed on 12/18/23. During an interview with the Alternate Administrator on 12/28/23 beginning at 2:02 PM, the Alternate Administrator reported a color blindness test should be done on hire for all staff performing direct patient care. The Alternate Administrator reported when compiling the personnel files for the survey, he/she could not find a color blindness test was completed on hire for RN 3 nor PCTs 1, 2, 5, 7. 5. During the entrance conference on 12/24/23, the administrator relayed the incenter of the clinic was open Monday through Saturday to provide hemodialysis treatments, opened at 5 AM each day, and that they provide dialysis and close at 5 PM on Tuesdays, Thursdays, and Saturdays and close at 10 PM on Mondays, Wednesdays and Fridays. A review of the facility’s ICHD total chlorine testing logs for 10/01/23 - 12/21/23 evidenced the following: a. On 10/17/23, facility staff logged the first total chlorine test at 12:00 PM. A review of Patient #2’s treatment summary from 10/17/23 indicated Patient began their hemodialysis treatment at 5:03 AM and ended at 8:48 AM; RN 3 first logged they confirmed chlorine tests at 12:00 PM. During an interview with Interim Clinic Manager 3 on 12/21/23 at 11:04 PM, the clinic manager reported Patient #2 was the first patient to begin ICHD treatment on 11/04/23. b. On 11/01/23, RN 3 logged they confirmed the total chlorine test at 8:06 AM. c. On 11/02/23, RN 3 logged they completed the total chlorine test at 4:45 AM and 11:58 AM. d. On 11/03/23, RN 3 logged they confirmed the total chlorine test at 8:07 AM. e. On 11/04/23, total chlorine tests were logged at 7:10 AM and 11:27 AM, which was 4 hours and 17 minutes in between tests. RN 3 logged they confirmed the test at 7:10 AM. f. On 11/07/23, RN 3 logged they confirmed the total chlorine test at 4:46 AM and 2:37 PM. g. On 11/09/23, RN 3 logged they completed the total chlorine test at 8:30 AM and confirmed the test at 12:30 PM. h. On 11/16/23, RN 3 logged he/she confirmed the total chlorine test at 7:50 AM and 11:16 AM. i. On 11/17/23, PCT 2 logged he/she confirmed the total chlorine test at 4:44 AM, 8:08 AM, and 11:24 AM. j. On 11/18/23, PCT 2 logged he/she completed the total chlorine test at 4:45 AM, 8:30 AM, and 12:20 PM. RN 3 logged he/she confirmed the test at 4:45 AM and 8:30 AM. k. On 11/19/23, PCT 2 logged he/she confirmed the total chlorine test at 4:40 AM. l. On 11/20/23, PCT 2 logged he/she confirmed the total chlorine test at 4:30 AM, 8:00 AM, and 11:45 AM. PCT 1 logged he/she completed the test at 3:23 PM. m. On 11/22/23, RN 3 logged he/she completed the total chlorine test at 2:45 PM. n. On 11/24/23, RN 3 logged he/she confirmed the total chlorine test at 4:51 PM. o. On 11/25/23, RN 3 logged he/she confirmed the total chlorine test at 4:42 AM and completed the test at 2:45 PM. p. On 11/28/23, RN 3 logged he/she completed the total chlorine test at 5:12 AM, 8:28 AM, and 11:57 PM. q. On 11/30/23, PCT logged they confirmed the total chlorine test at 4:50 AM, 8:12 AM, and 2:58 PM. RN 3 logged they completed the test at 11:30 AM. r. On 12/02/23, RN 3 logged he/she confirmed the total chlorine test at 4:45 AM. PCT 2 documented he/she confirmed the total chlorine test results at 2:48 PM. s. On 12/05/23, PCT 2 logged he/she completed the total chlorine test 4:47 AM and 8:15 AM. t. On 12/07/23, RN 3 logged he/she confirmed the total chlorine test at 4:40 AM and completed the test at 11:22 AM. u. On 12/08/23, PCT 7 logged he/she completed the total chlorine test at 2:39 PM. v. On 12/09/23, RN 3 logged he/she completed the total chlorine test and PCT 7 logged he/she confirmed the test at 8:10 AM, 11:28 AM, and 2:58 PM. w. On 12/12/23, RN 3 logged he/she confirmed the total chlorine test at 8:16 AM and 11:30 AM and completed the test at 2:56 PM. x. On 12/13/23, PCT 7 logged he/she confirmed the total chlorine test at 8:06 AM. RN 3 logged he/she confirmed the test at 2:53 PM. y. On 12/14/23, PCT 2 logged he/she confirmed the total chlorine test at 8:00 AM and completed the test at 2:47 PM. RN 3 logged he/she confirmed the test at 2:47 PM. z. On 12/15/23, RN 3 logged he/she confirmed the total chlorine test at 8:07 AM and 2:47 PM. PCT 7 logged he/she confirmed the test at 11:25 AM. aa. On 12/16/23, PCT 2 logged he/she confirmed the total chlorine test at 4:42 PM, RN 3 logged he/she completed the test at 8:15 AM and 3:20 PM, and PCT 7 logged he/she confirmed the test at 8:15 AM and 3:20 PM. 6. During an interview with BioMed Technician 1 on 12/19/23 beginning at 9:53 AM, the technician reported the ICHD product water should be tested for total chlorine every 4 hours. During a follow-up interview with BioMed Technician 1 on 12/21/23 beginning at 1:35 PM, the technician reported when staff were unable to enter the total chlorine test results in TMS they were to document on a paper log then enter the result into TMS at a later date.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to ensure expired medical supplies were removed, all sharps were stored safely, and any medication or solution drawn up and not immediately used was labeled, which had the potential to affect all facility patients. Findings include: 1. A review of a facility policy titled “Storage of Supplies,” dated 04/05/21, indicated supplies should be stored “in a manner that does not present a safety hazard.” The policy also indicated staff should dispose of supplies that had reached the expiration date. 2. During an observation of one of two facility supply rooms on 12/19/23 beginning at 9:00 AM, the following expired items were observed and available for patient care use: a. 2 boxes of isolation gowns expired 05/20/22 b. 1 box of XL isolation gowns expired 06/08/23 c. 1 box of M isolation gowns expired 06/08/23 d. 2 bottles of hand sanitizer, one expired 07/23 and one expired 11/23 3. During an interview with Patient Care Technician (PCT) 3 on 12/19/23 beginning at 9:15 AM, the technician reported he/she was responsible for maintaining the supply rooms and discarding expired products. PCT 3 reported they were unaware the observed isolation gowns had expired. 4. During an observation on the ICHD treatment floor on 12/19/23 beginning at 11:40 AM, the surveyor observed the following, a. 3 suture removal kits expired 04/30/23 b. 1 recirculation connector expired 06/30/22 c. 1 unlabeled open bottle of ExSept disinfectant d. 1 gold laboratory tube expired 10/31/23 e. 2 unopened bottles of 2.0 K+ (potassium) and 2.25 Ca++ (calcium) dialysate expired 08/31/22 f. 4 unopened bottles of 2.0 K+ and 2.25 Ca++ dialysate expired 11/30/23 g. 1 opened bottle of 2.0 K+ and 3.0 Ca++ dialysate, expired 11/30/23 and labeled as opened on 12/18/23 During an interview with PCT 3 on 12/19/23 beginning at 12:45 PM, the technician confirmed the bottles of dialysate observed were expired. h. The following supplies were observed in an unlocked drawer: 1) 1 stick kit with a fistula needle expired 07/25/23 2) 1 uncapped syringe filled with an unlabeled medication/solution 3) 1 capped syringe filled with an unlabeled medication/solution 5. During an interview with PCT 5 on 12/19/23 beginning at 11:46 AM, the technician reported syringes stored in a supply drawer should be capped and labeled with the solution/medication.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) facility failed to ensure staff documented dialysis access site checks according to facility policy for 3 of 5 complete records reviewed as part of the complaint investigation regarding the facility’s operating status on 11/04/23 (Patients #2, 3, and 4). Findings include: 1. A review of facility policy #45284 titled “Patient Assessment and Monitoring,” dated 05/01/23, indicated safety checks should be documented at least every 45 minutes during treatment. 2. A review of Patient #2’s clinical record evidenced the following: a. On 11/02/23, PCT documented Patient’s access check at 5:16 AM. The flowsheet indicated Patient’s next access check was not documented again until 7:32 AM, which was 2 hours and 16 minutes after the previous check. b. On 11/18/23, PCT 1 documented Patient’s access check at 5:29 AM. The flowsheet indicated Patient’s next access check was not documented again until 7:36 AM, which was 2 hours and 7 minutes after the previous check. Later during treatment, Patient’s access check was documented at 8:02 AM. The flowsheet indicated Patient’s access site was not rechecked until 9:28 AM, which was 1 hour and 26 minutes after the previous check. c. On 12/07/23, PCT 5 documented Patient’s access check at 8:03 AM. The flowsheet indicated Patient’s next access check was not documented again until 9:21 AM when Patient’s treatment had ended. This was 1 hour and 18 minutes after the previous check. d. On 12/16/23, PCT 3 documented Patient’s access check at 7:33 AM. The flowsheet indicated Patient’s next access check was not documented until 8:32 AM, which was 59 minutes after the previous check. 3. A review of Patient #3’s clinical record evidenced the following: a. On 11/04/23, RN 3 documented Patient ‘s access check at 9:33 AM. The flowsheet indicated Patient’s next access check was not documented again until 10:35 AM, which was 1 hour and 2 minutes after the previous check. Later during the treatment, RN 3 documented Patient’s access check at 11:04 AM. The flowsheet indicated Patient’s next access check was not documented again until 12:02 PM, which was 58 minutes after the previous check. After 12:02 PM, the flowsheet also indicated Patient’s next access check was not documented until 1:06 PM, which was 1 hour and 4 minutes after the previous check. b. On 11/09/23, PCT 1 documented Patient’s access check at 8:31 AM. The flowsheet indicated Patient’s next access check was not documented again until 10:36 AM, at which time Patient requested to end treatment early. This was 2 hours and 4 minutes after the previous check. c. On 12/02/23, PCT 1 documented Patient’s access check at 9:31 AM. The flowsheet indicated Patient’s treatment ended at 10:30 AM. The flowsheet failed to evidence staff documented any further access checks after 9:31 AM. 4. A review of Patient #4’s clinical record evidenced the following: a. On 11/25/23, PCT 5 documented Patient’s access check at 10:36 AM. The flowsheet indicated Patient ‘s next access check was not documented again until 12:01 PM, which was 1 hour and 24 minutes after the previous check. b. On 12/07/23, PCT 1 documented Patient’s access check at 9:57 AM. The flowsheet indicated Patient’s next access check was not documented again until 11:02 AM, which was 1 hour and 5 minutes after the previous check. 5. During an interview with the Administrator on 12/15/23 beginning at 1:20 PM, the Administrator reported staff should document access site checks every 30 minutes.”

“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: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) facility failed to ensure Patient’s estimated dry weight was adjusted per facility algorithm for 2 of 3 records reviewed of an in-center hemodialysis patient with a change in weight after hospitalization (Patients #1, 4), failed to ensure the ICHD patients’ vital signs were obtained according to the facility policy for 3 of 7 ICHD records reviewed (Patients #2, 3, and 4), failed to ensure the Registered Nurse and/or MD was notified for blood pressure or heart rate readings being out of parameters for 3 of 7 ICHD records reviewed (Patients #1, 4, and 5), and failed to ensure the RN re-assessed a patient’s abnormal lung sounds for 1 of 7 ICHD records reviewed (Patient #6). Findings include: 1. A review of facility policy #45265 titled “Nursing Supervision and Delegation,” dated 11/06/23, indicated the Patient Care Technician (PCT) should notify the on-duty Registered Nurse (RN) of the following: a. A systolic (the top number on the blood pressure (BP) reading) greater than 180 or less than 100 b. A diastolic (the bottom number on the BP reading greater than 100 2. A review of facility policy #45284 titled “Patient Assessment and Monitoring,” dated 05/01/23, indicated pre-treatment, staff should obtain the patient’s weight and compare to the patient’s estimated dry weight (EDW, the physician-ordered weight the patient was to reach at the end of dialysis treatment). During treatment, the patient’s BP and heart rate (HR) should be documented at minimum every 45 minutes. The patient’s BP should be rechecked “after a drop that requires interventions such as administering normal saline. After treatment, staff should “ensure vital signs and overall condition are stable for discharge” and the RN would re-assess the patient’s lung sounds “as indicated.” All findings were to be documented in the patient’s record. 3. A review of facility policy #45286 titled “Determination of Pulse [Heart] Rate,” dated 02/07/22, indicated the in-center hemodialysis (ICHD) patients’ heart rates should be obtained “every 30 minutes or more” during hemodialysis, a new onset heart rate below 60 (beats per minute) or above 100 required notification of the on-duty nurse, and a new heart rate less than 50 or above 120 required notification of the patient’s physician. 4. A review of the facility policy titled “CMAB Recommended Volume Evaluation and Management Algorithm Version 2.0,” dated 04/11/19, indicated if the in-center hemodialysis patient’s pre-treatment weight was 1.0 kilogram (kg) or more below the patient’s EDW, staff were to evaluate for signs and symptoms of dehydration or fluid overload. If the patient had no signs or symptoms of dehydration or fluid overload, staff were to consult the patient’s physician for a new EDW. If the patient was exhibiting signs of dehydration or fluid overload, the EDW was to be adjusted at the end of each dialysis session. 5. A review of Patient #1’s clinical record indicated Patient’s dialysis prescription included an EDW of 78.0 kg. The record indicated Patient was admitted to a local hospital from 10/21/23 - 11/02/23. Patient #1 missed their treatment on 11/04/23 due to the facility not opening at its scheduled time. On 11/07/23, Patient had their first ICHD treatment after hospitalization; Patient’s pre-treatment weight was 77.10 kg. Corporate Employee 4, a nurse, documented Patient’s weight was to be decreased by 0.5 kg at their next treatment per the facility’s algorithm. The record evidenced the following: a. On 11/09/23 (Patient’s next treatment after 11/07/23), Patient’s pre-treatment weight was 77.7 kg. At 5:26 AM, the Alternate Administrator documented Patient reported shortness of breath the night prior (11/08/23), the physician was notified, and Patient would be monitored for “treatment tolerance.” Patient’s treatment was started on 5:28 AM and Patient Care Technician (PCT) 9 documented at 7:55 AM Patient #1 reported lightheadedness and blurry vision. Patient’s ultrafiltration (fluid removal) was turned off at that time and was not resumed. At 8:33 AM, PCT 9 documented Patient’s blood pressure was 92/73 and heart rate was 144. Patient’s post-treatment heart rate was 146 and weight was 77.8 kg. The record failed to evidence Patient’s physician was notified Patient #1 did not tolerate treatment or of Patient’s post-treatment elevated heart rate. b. On 11/25/23, PCT 1 documented Patient’s BP was 69/54 and HR was 157. The record failed to evidence the technician notified the on-duty RN of Patient’s abnormal vital signs. c. On 12/02/23, Patient’s pre-treatment weight was 91.4 kg, which was 3.6 kg over the previous treatment’s (12/01/23) weight and 12.6 kg over Patient’s EDW. At 5:20 AM, RN 6 documented Patient had shortness of breath at rest, 4+ edema (swelling, assessed on a scale of severity from 1+ to 4+) to their sacrum, ankles, and lower legs, ascites (swelling to the abdomen), and facial edema. The flowsheet indicated Patient #1 was started on treatment at 5:25 AM and at 5:50 AM, Patient reported his/her shortness of breath had worsened. Patient’s physician was contacted at this time and Patient was sent to a local emergency department for evaluation. 6. A review of Patient #2’s clinical record evidenced the following: a. On 11/02/23, PCT 10 documented Patient’s vital signs at 5:16 AM. The flowsheet failed to evidence Patient’s vital signs were not rechecked until 7:32 AM, 2 hours and 16 minutes after the previous check. b. On 11/18/23, PCT 1 documented Patient’s vital signs at 5:29 AM. The flowsheet failed to evidence Patient’s vital signs were not rechecked until 7:36 AM, 2 hours and 7 minutes after the previous check. Later during treatment, Patient’s vital signs were documented at 8:02 AM. The flowsheet indicated Patient’s vital signs were not rechecked until 9:28 AM, 1 hour and 26 minutes after the previous check. c. On 12/07/23, PCT 5 documented Patient’s vital signs at 8:03 AM, at which time Patient’s blood pressure was 91/58. The flowsheet indicated Patient’s vital signs were not rechecked until 9:21 AM when Patient’s treatment had ended. This was 1 hour and 18 minutes after the previous check. d. On 12/16/23, PCT 3 documented Patient’s vital signs at 7:33 AM. The flowsheet indicated Patient’s vital signs were not rechecked until 8:32 AM, which was 59 minutes after the previous check. 7. A review of Patient #3’s clinical record evidenced the following: a. On 11/04/23, RN 3 documented Patient’s vital signs at 9:33 AM. The flowsheet failed to evidence Patient’s vital signs were not rechecked until 10:35 AM, 1 hour and 2 minutes after the previous check. Later during the treatment, RN 3 documented Patient’s vital signs at 11:04 AM, including a blood pressure of 92/48. The flowsheet failed to evidence Patient’s vital signs were not rechecked until 12:02 PM, 58 minutes after the previous check. After 12:02 PM, The flowsheet failed to evidence Patient’s vital signs were not rechecked until 1:06 PM, an hour and 4 minutes after the previous check. b. On 11/09/23, PCT 1 documented Patient’s vital signs at 8:31 AM. The flowsheet failed to evidence Patient’s vital signs were not rechecked until 10:35 AM, 2 hours and 4 minutes after the previous check, at which time Patient requested to end treatment early due to feeling lightheaded. c. On 12/02/23, PCT 1 documented Patient’s vital signs at 9:31 AM. The flowsheet failed to evidence Patient’s vital signs were not rechecked until after Patient’s treatment ended at 10:30 AM, 59 minutes after the previous check. 8. A review of Patient #4’s clinical record indicated Patient’s dialysis prescription included an EDW of 82.5. The record evidenced the following: a. On 11/25/23 at 10:36 AM, PCT 5 documented Patient’s BP was 80/56 and HR was 103. The flowsheet failed to evidence Patient’s vital signs were not rechecked until 12:01 PM, 1 hour 24 minutes after the previous check. At 1:05 PM, PCT 5 documented Patient’s BP was 98/66. At 1:32 PM, PCT 5 documented Patient’s BP was 170/47. The flowsheet failed to evidence the technician notified the RN of the abnormal BP or HR or a significant change in BP and failed to evidence Patient’s vital signs were assessed per policy. b.The record indicated Patient #4 was hospitalized for acute respiratory failure from 11/30/23 - 12/03/23. Patient’s first treatment post hospitalization was 12/05/23. The treatment flowsheet for 12/05/23 indicated Patient #4’s pre-treatment weight was 81.0 kg, which was 1.5 kg below their EDW. The flowsheet indicated Patient’s treatment began at 9:52 AM and RN 3 documented Patient’s blood pressure was 163/144 at 9:56 AM. RN 3 documented at 9:55 AM Patient’s breath sounds were decreased and Patient had 2+ edema to both ankles and feet. The flowsheet indicated PCT 7 documented Patient’s vital signs at 10:37 AM, after which Patient #4’s vital signs were not documented again until 11:32 AM, 55 minutes after the last check. The flowsheet failed to evidence Patient’s EDW was adjusted per facility algorithm nor Patient’s physician was notified Patient’s weight was below EDW after hospitalization. c. On 12/07/23, PCT 1 documented Patient’s vital signs at 9:57 AM. The flowsheet indicated Patient’s vital signs were not rechecked until 11:02 AM, which was 1 hour and 5 minutes after the previous check. d. On 12/09/23, Patient’s pre-treatment weight was 81.4, which was 1.1 kg below Patient’s ordered EDW. The flowsheet failed to evidence Patient’s EDW was adjusted per facility algorithm nor Patient’s physician was notified Patient’s weight was below their EDW prior to treatment. e. During an interview with Patient #4 on 12/14/23 beginning at 2:40 PM, Patient reported he/she was recently hospitalized and had lost weight during the hospitalization. Patient #4 reported since returning to the facility, his/her EDW had not been adjusted to reflect their new weight, and the facility had not taken off any fluid. f. During an interview with Other Physician 1 on 12/14/23 beginning at 4:01 PM, the physician reported the ICHD staff should notify the physician if a patient’s pre-treatment weight was “0.5 - 1.0” kgs below their EDW. 9. A review of Patient #5’s clinical record evidenced a dialysis treamtnet flowsheet dated 12/15/23, in which PCT 6 documented Patient’s BP was 171/107 at 5:34 PM. The flowsheet failed to evidence the PCT notified the on-duty RN of the elevated BP. 10. A review of Patient #6’s clinical record evidenced the following: On 12/06/23 at 7:51 AM, RN 1 documented Patient had wheezy lung sounds and 2+ edema to both ankles. The flowsheet indicated Patient’s treatment ended at 11:52 AM and tehir post treatment sitting BP was 162/107, and standing BP was 174/98. RN 1 noted Patient’s high BP and documented he/she instructed Patient #6 to “take BP medications upon arrival at home.” The flowsheet failed to evidence the nurse re-assessed Patient’s lung sounds prior to leaving treatment. The record indicated Patient #6 was hospitalized at a local hospital on 12/08/23 for pneumonia and sepsis (a complication of an infection which would be life-threatening). During an interview with RN 1 on 12/27/2023 with RN 1 and the Alternate Administrator, RN1 reported if a patient had abnormal symptoms during their nurse assessment, including wheezy lung sounds, the nurse would re-assess for the abnormal symptom(s) prior to Patient leaving and would document the re-assessment. 11. During an interview with the Administrator and Alternate Administrator on 12/15/23 beginning at 1:20 PM, the Administrator reported in-center hemodialysis patients should have vital signs documented every 45 minutes and the PCT should notify the RN on-duty of a heart rate above 100. The Alternate Administrator reported the RN should notify Patient’s physician of a heart rate above 120.”

“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: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) facility failed to administer medications for the treatment of anemia (a condition where the number of red blood cells is decreased) according to its anemia management protocol for 1 of 4 in-center hemodialysis records reviewed for anemia management (Patient #6). Findings include: 1. A review of the facility policy titled “Corporate MAB Recommended Anemia Algorithm - Mircera IVP [IV push] Administration (In Center Only) Version 4.0,” revised 09/07/17, indicated Mircera (an erythropoiesis-stimulating agent (ESA) medication used to treat anemia) would be dosed according to the patient’s hemoglobin level (blood test used to assess the number of red blood cells). The policy indicated Mircera was generally to be administered every 2 weeks and dose changes were to be made every 28 days. The policy also indicated if a patient’s maintenance dose was 100 micrograms (mcg) every 2 weeks and there was a rapid rise in the patient’s hemoglobin, the patient’s dose was to decrease to 75 mcg every 2 weeks. 2. A review of Patient #6’s clinical record indicated the patient had orders to administer Mircera according to the facility’s in-center anemia algorithm. The record indicated 100 mcg of Mircera was administered on 11/21/23, the patient’s hemoglobin was 9.8 on 11/21/23, and the hemoglobin increased to 11.0 on 11/29/23. The record included an “Anemia Algorithm Dose Change Assessment,” documented on 12/02/23 by Corporate Registered Nurse (RN) 1, which indicated the patient’s Mircera dose was to decrease from 100 mcg to 75 mcg every 2 weeks. The record failed to evidence the patient received a dose of Mircera until 12/20/23, which was 15 days after the dose was due (12/05/23). The record also indicated the patient’s hemoglobin had decreased to 8.4 on 12/20/23. 3. During an interview with RN 1 and the Alternate Administrator on 12/22/23 beginning at 2:45 PM, the Alternate Administrator reported Corporate RN 1 and Corporate Employee 2 were responsible for adjusting the facility patients’ Mircera doses. 4. During an interview with the Alternate Administrator on 12/27/23 at 1:25 PM, the Alternate Administrator reported a dose of Mircera should have been administered to Patient #6 on 12/06/23.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) facility failed to ensure the patient signed the completed their plan of care for 2 of 7 in-center hemodialysis (ICHD) records reviewed (Patient #1 and 4). Findings include: 1. A review of facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 07/03/23, indicated the patient must sign the plan of care to acknowledge the information in the plan. 2. A review of Patient #1’s clinical record indicated the patient’s admission date was 12/30/20. The record indicated on 02/09/23, Patient declined to attend their annual plan of care meeting and the nurse was to review the plan of care with Patient after the meeting. The record indicated a plan of care meeting was held with the interdisciplinary team (IDT) on 02/28/23. The record failed to evidence the IDT obtained Patient’s signature on the completed plan of care nor why there was no signature. 3. A review of Patient #4’s clinical record indicated the patient’s admission date was 02/23/23. The record indicated on 03/16/23, Patient declined to attend their annual plan of care meeting and the nurse was to review the plan of care with Patient after the meeting. The record indicated a plan of care meeting was held with the interdisciplinary team (IDT) on 03/21/23. The record failed to evidence the IDT obtained Patient’s signature on the completed plan of care nor why there was no signature. 4. During an interview with the Alternate Administrator on 12/22/23 beginning at 10:46 AM, the Alternate Administrator reported when a patient declined to attend the plan of care meeting, the nurse was to review the completed plan of care with the patient and obtain the patient’s signature at that time.”

“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: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) facility failed to ensure the unstable patient’s plan of care was updated according to facility policy for 1 of 1 record reviewed of an unstable home peritoneal dialysis patient (Patient #8). Findings include: A review of facility policy #45283 titled “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 07/03/23, indicated unstable patients were to be reassessed by the interdisciplinary team (IDT) monthly. The policy also indicated any updates to the plan of care were to be documented “until the issues have been resolved.” A review of Patient #8’s clinical record indicated the patient’s admission date was 05/16/2023 and the patient’s modality was home peritoneal dialysis. The record indicated the facility’s IDT held a plan of care meeting on 10/17/23 due to the patient’s status changing from “stable” to “unstable.” The plan of care indicated Patient #8 was classified as unstable due to “concurrent poor nutrition status, unmanaged anemia and inadequate dialysis” and the next meeting was to be held in 30 days (11/16/23). The record failed to evidence the patient’s plan of care had been updated after the 10/17/23 meeting. During an interview with Social Worker (MSW) 1 on 12/27/23 beginning at 3:35 PM, the social worker reported Patient #8 was still classified as “unstable” and confirmed the patient’s last plan of care meeting was 10/17/23. MSW 1 reported the patient’s care plan had not been updated since October due to the patient missing appointments in the clinic. The social worker reported the facility was able to update unstable in-center hemodialysis patients’ plans of care without the patient being present at the meeting. During an interview with Home Therapy Nurse 5 on 12/27/23 beginning at 4:05 PM, the nurse reported the patient missed multiple clinic visits and did not return phone calls, therefore the IDT was unable to update the patient’s assessment. The nurse reported the patient assessment needed to be updated in order to update the patient’s plan of care. During an interview with Area Home Therapy Lead 5 on 12/27/23 beginning at 5:27 PM, the nurse reported the facility would an unstable home therapy patient’s plan of care was to be updated every 30 days. Area Home Therapy Lead 5 also stated if the IDT was unable to perform the patient assessment, the plan of care could not be updated, and the plan of care meeting would be rescheduled for the following month. Area Home Therapy Lead 5 reported staff should document the reason the plan of care was not updated within the clinical record.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the End Stage Renal Dialysis (ESRD) facility failed to ensure the interdisciplinary team noted trends of the patient not following their dialysis prescription when reviewing home dialysis treatment flowsheets for 1 of 2 records reviewed of patients with home peritoneal dialysis (Patient #9). Findings include: 1. A review of the facility job description for “Staff Home Therapy RN,” dated 09/06/19, indicated the nurse was responsible for assessing the patients’ “response to home dialysis treatment therapy” and document “any treatment related data.” 2. A review of the Baxter peritoneal dialysis (PD) machine’s manual titled “Amia Automated PD System Patient Guide” indicated at the end of the dialysis treatment cycle, the machine would complete a “Night Drain,” where the fluid which filled the patient’s peritoneum would empty back into the machine. The manual indicated if the patient had met certain conditions, he/she had the option to select “Smart Drain,” which would bypass the Night Drain. The manual indicated the Smart Drain would stop the current drain and add 1-2 cycles to the patient’s treatment, which would reduce the patient’s fill volume per cycle. 3. A review of Patient #9’s clinical record indicated the patient was admitted on 11/08/22 and his/her dialysis modality was home peritoneal dialysis. The record indicated the patient’s dialysis prescription included 4 cycles per treatment, 2500 milliliters (ml) per fill, with a total of 10,000 ml fill per treatment. Review of the patient’s treatment flowsheets from 10/23/23 - 11/16/23 evidenced the following: a. On 10/26/23, the patient’s 4th cycle fill volume was 2,319 ml and the total fill volume for the treatment was 9,819 ml. b. On 10/27/23, the patient’s 4th cycle fill volume was 2,319 ml and the total fill volume for the treatment was 9,790 ml. c. On 10/28/23, the patient’s 4th cycle fill volume was 2,370 ml and the total fill volume for the treatment was 9,870 ml. d. On 10/29/23, the patient’s 4th cycle fill volume was 2,320 ml and the total fill volume for the treatment was 9,820 ml. e. On 10/30/23, the patient’s 4th cycle fill volume was 2,304 ml and the total fill volume for the treatment was 9,804 ml. f. On 10/31/23, the patient’s 4th cycle fill volume was 2,258 ml and the total fill volume for the treatment was 9,761 ml. g. On 11/01/23, the patient’s 4th cycle fill volume was 2,278 ml and the total fill volume for the treatment was 9,782 ml. h. On 11/02/23, the patient’s 4th cycle fill volume was 2,338 ml and the total fill volume for the treatment was 9,837 ml. i. On 11/03/23, the patient’s 4th cycle fill volume was 2,332 ml and the total fill volume for the treatment was 9,832 ml. j. On 11/04/23, the patient’s 4th cycle fill volume was 2,345 ml and the total fill volume for the treatment was 9,844 ml. k. On 11/05/23, the patient’s 4th cycle fill volume was 2,343 ml and the total fill volume for the treatment was 9,841 ml. l. On 11/06/23, the patient’s 4th cycle fill volume was 2,347 ml and the total fill volume for the treatment was 9,846 ml. m. On 11/07/23, the patient’s 4th cycle fill volume was 2,345 ml and the total fill volume for the treatment was 9,845 ml. n. On 11/08/23, the patient’s 4th cycle fill volume was 2,239 ml and the total fill volume for the treatment was 9,739 ml. o. On 11/09/23, the patient’s 4th cycle fill volume was 2,340 ml and the total fill volume for the treatment was 9,839 ml. p. On 11/10/23, the patient’s 4th cycle fill volume was 2,322 ml and the total fill volume for the treatment was 9,822 ml. q. On 11/11/23, the patient’s 4th cycle fill volume was 2,294 ml and the total fill volume for the treatment was 9,794 ml. r. On 11/12/23. the patient’s 4th cycle fill volume was 2,283 ml and the total fill volume for the treatment was 9,782 ml. s. On 11/13/23, the patient’s 4th cycle fill volume was 2,299 ml and the total fill volume for the treatment was 9,799 ml. t. On 11/14/23, the patient’s 4th cycle fill volume was 2,350 ml and the total fill volume for the treatment was 9,850 ml. u. On 11/15/23, the patient’s 4th cycle fill volume was 2,343 ml and the total fill volume for the treatment was 9,841 ml. v. On 11/16/23, the patient’s 4th cycle fill volume was 2,392 ml and the total fill volume for the treatment was 9,892 ml. The record indicated Patient #9 was seen in the facility’s home therapy clinic by the interdisciplinary team (IDT), including the Medical Director and Home Therapy Nurse 5. The RN documented Patient #9’s dialysis adequacy was not being met and the patient’s dialysis prescription was modified to a fill volume of 2,700 ml per cycle for 4 cycles. The record failed to evidence the home therapy nurse nor medical director noted the patient was not meeting their fill volume during the 4th fill cycle nor total treatment fill volume on the above dates. The record evidenced: w. On 12/04/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were between 1,799 -1,800 ml. x. On 12/06/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were between 1,799 -1,800 ml. y. On 12/07/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were between 1,800 - 1,801 ml. z. On 12/09/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were between 1,799 -1,800 ml. aa. On 12/10/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were between 2,024-2,026 ml. bb. On 12/11/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were between 2,025-2,026 ml. cc. On 12/13/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were between 2,025-2,026 ml. dd. On 12/14/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were between 2,024-2,025 ml. ee. On 12/18/23, the patient had 5 cycles and the fill volume for the 3rd - 5th cycles were 1,800 ml. During a home peritoneal dialysis clinic visit observation with Patient #9 on 12/21/23 beginning at 1:55 PM, the facility’s IDT, including the Medical Director, Home Therapy Nurse 5, Social Worker 1, and Dietitian 1, met with the patient. The Medical Director informed the patient he/she was not meeting their dialysis adequacy and the patient’s dialysis prescription was modified to a fill volume of 3,000 per cycle for 4 cycles. During the clinic visit, the IDT failed to note and/or discuss the patient’s frequent use of the “Smart Button,” which altered the patient’s treatment and led to the patient not meeting their fill volume per cycle as ordered. During an interview with Home Therapy Nurse 4 and Area Home Therapy Lead 5 on 12/27/23 beginning at 4:45 PM, Home Therapy Nurse 4 reported the if the patient pushed the “Smart Button,” the peritoneal dialysis machine would increase the number of the patient’s treatment cycles and decrease the amount of fill volume per cycle. Area Home Therapy Lead 5 reported this was a “safety feature” and would decrease the patient’s risk for overfilling their abdomen with fluid.”

“H-MONITOR H20 /DIALYSATE INC ON SITE EVAL CFR(s): 494.100(c)(1)(v) Services include, but are not limited to, the following: (v) Monitoring of the quality of water and dialysate used by home hemodialysis patients including conducting an onsite evaluation This Standard is not met as evidenced by: 42617 Based on record review and interview, the End Stage Renal Disease (ESRD) facility failed to document a review all home hemodialysis patients’ chemical testing of source water and note any abnormalities for 1 of 1 home hemodialysis patients with a documented high level of arsenic in their source water (Patient #32). Findings include: A review of facility policy #47326 titled “NxStage PureFlor SL: Testing for Water Quality - Chemical,” date 09/05/23, defined “source water” as the water used to supply the NxStage hemodialysis machine. The policy indicated the source water arsenic limit per NxStage was 0.01 and the source water arsenic limit per Fresenius Kidney Care (FKC, corporate owner of the facility) was 0.04. When the patient’s source water test results exceeded the NxStage limits but not the FKC limits, the policy indicated the patient’s source water was to be tested semi-annually instead of annually. A review of Patient #32’s record indicated the patient’s admission date was 06/19/18 and the patient was receiving home hemodialysis. The patient’s tap water was tested on 09/05/23 with an arsenic level result of 0.017. The patient’s tap water was tested again on 09/19/23 with an arsenic level result of 0.017. The record failed to evidence the facility reviewed the patient’s repeat tap water test results and noted the 09/19/23 elevated arsenic levels. During an interview with Area Home Therapy Lead 5 on 12/21/23 beginning at 11:45 AM, the employee reported Patient #32’s abnormally arsenic levels were identified by the facility on 12/18/23. Area Home Therapy Lead 5 also reported the home therapy nurse was responsible for reviewing the home hemodialysis patients’ chemical test results”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 42617 Based on observation, record review, and interview, the Medical Director failed to ensure all policies and procedures were followed by staff for 2 of 3 observations of staff performing cannulation of an arteriovenous (AV) fistula (Patient Care Technicians (PCT) 1, 4), 1 of 3 observations of staff performing central venous catheter exit site care (PCT 3), and 1 of 1 observations of staff performing a peritoneal dialysis (PD) site dressing change (Home Therapy Nurse 5). Findings include: 1. A review of facility policy #47664 titled “Hand Hygiene,” dated 11/06/23, indicated staff should perform hand hygiene after contact with non-intact skin and wound dressings. 2. A review of facility policy #45178 titled “Access Assessment and Cannulation,” dated 07/05/2022, indicated when disinfecting the fistula cannulation site with a 70% alcohol pad, staff should clean the site for 30 seconds and allow to dry prior to cannulation. 3. A review of facility policy #45611 titled “Routine Peritoneal Catheter Exit Site Care,” dated 05/02/22, indicated when cleaning a PD exit site, staff should start close to the catheter and move outward in a circular motion, in order to move bacteria away from the exit site. 4. During an in-center hemodialysis (ICHD) observation on 12/18/23 beginning at 12:22 PM at Station #11, PCT 4 initiated Patient #14’s dialysis by accessing an AV fistula. PCT 4 was observed cleaning the patient’s first cannulation site using a 70% alcohol wipe for 12 seconds. During an interview with PCT 4 on 12/18/23 beginning at 4:35 PM, the technician reported each AV fistula cannulation site should be cleaned for 30 seconds with a 70% alcohol wipe prior to cannulation. 5. During an ICHD observation on 12/18/2023 beginning at 3:18 PM at Station #7, PCT 3 cleaned Patient #17’s central venous catheter (CVC) exit site, applied a new dressing, then began to initiate dialysis using the CVC. The technician failed to change gloves and perform hand hygiene in between changing the patient’s CVC dressing and initiating dialysis. During an interview with PCT 3 on 12/20/23 beginning at 9:45 AM, the technician reported after performing CVC exit site care, he/she would change their gloves and perform hand hygiene prior to initiating dialysis. 6. During an ICHD observation on 12/20/23 beginning at 9:27 AM at Station #3, PCT 1 initiated Patient #21’s dialysis by accessing an AV fistula. PCT 1 was observed cleaning the patient’s first and second cannulation sites using a 70% alcohol wipe for 5 seconds. During an interview with PCT 1 on 12/20/23 beginning at 10:45 AM, the technician reported each AV fistula cannulation site should be cleaned for 30 seconds with a 70% alcohol wipe prior to cannulation. 7. During an observation of a home therapy clinic visit with Patient #9, a home PD patient, Home Therapy Nurse 5 was observed changing the patient’s PD catheter site dressing. The nurse used a disinfectant-soaked gauze pad to wipe from the catheter exit site outward in a straight line for a total of 3 times. Home Therapy Nurse 5 then turned the gauze pad over and wiped from the exit site outward in a straight line again. During an interview with Home Therapy Nurse 5 on 12/21/23 beginning at 4:20 PM, the nurse reported when changing a PD catheter dressing, the exit site should be cleaned in circular motions from the exit site outward to “take the germs out.” The nurse reported he/she did not cleanse Patient #9’s PD exit site in circular motions as they were assessing the site for the presence of proud flesh (excessive granulation tissue abnormally formed in a wound bed). 8. During an interview with the Administrator, Alternate Administrator, and Interim Clinic Manager 3 on 12/21/23 beginning at 4:15 PM, Interim Clinic Manager 3 reported staff should clean an AV fistula site for 30 seconds prior to cannulation. The clinic manager also reported staff should change gloves in between performing CVC site care and initiating dialysis.”