Fmc - Indianapolis-East

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to ensure emergency equipment was safe for use and was checked for expiration dates, and the Emergency Cart had been locked for 1 of 1 Emergency Carts observed. Findings include: 1. A review of a dated 07/07/2025, Fresenius Kidney Care policy titled “Emergency Medication, Equipment, and Supplies” indicated but was not limited to, “Emergency Cart ...The emergency cart must be: ... Checked monthly or after use for contents, expiration dates ... The following minimum emergency supplies and equipment must be on the premises at all times, clean, functional, accessible and immediately available: Automated External Defibrillator (AED) ... The emergency cart must be: Locked when not in use ... “ 2. During an observation on 07/28/2025 at 8:30 AM, the Emergency Cart supplies, and equipment were reviewed. The Emergency Cart had been left unlocked and contained an AED with 1 package of pads with an expiration date of 06/24/2025. During an interview on 07/28/2025 at 8:35 AM, PCT 1 confirmed the AED pads had expired. PCT 1 further communicated the floor RNs were to check the Emergency Cart every morning and to ensure items were not expired and document in the computer system. 3. During an interview on 07/28/2025 at 8:41 AM, RN 1 indicated the crash cart should had been checked monthly by the floor RN and remained locked.”

“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: 44232 Based on record review and interview, the facility failed to ensure the PCT had notified a RN of a blood pressure (BP) not within parameters for 2 (Patients: #1,and 12) of 3 records reviewed with documented abnormal blood pressures during their dialysis treatment and failed to ensure direct patient care staff monitored the patients during their dialysis treatment within the timelines to ensure patient safety in 10 of 15 records reviewed. (Patients: #1, 4, 5, 7, 8, 9, 10, 11, 12, and 15) Findings Include: 1. A review of a Fresenius Kidney Care policy dated 05/01/2023, titled “Patient Assessment and Monitoring” indicated but was not limited to, “ ... monitoring patient during treatment ... Blood Pressure.... Report to the nurse: Systolic [top number] blood pressure greater than 180 mm/Hg [millimeters of Mercury]. Diastolic [bottom number] blood pressure greater than 100 mm/Hg. Blood pressure less than or equal to 100 mm/Hg systolic....” 2. A review of a Fresenius Kidney Care policy dated 09/05/2023, titled “Patient Monitoring and Safety Checks During Hemodialysis Treatment” indicated but was not limited to “ ... Patients must be under continual observation ... Monitor and document pressure and pulse rate every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations ... Patient Monitoring includes: ... Blood pressure, pulse, respirations ... “ 3. A review of the clinical record for Patient #1 was reviewed. 8 treatment records dated 07/02/2025 through 07/26/2025 evidenced the following: Treatment sheet dated 07/14/2025, a blood pressure reading of 206/92 and pulse 76 at 5:04 AM by PCT 1. PCT 1 documented the next blood pressure reading 220/109 and pulse 73 at 5:32 AM. There was no evidence the RN was notified of systolic blood pressures greater than 180 mm/Hg. During an interview on 07/28/2025 at 12:00 PM PCT 1 communicated patient safety, blood pressure and pulse checks were to be completed every 30 minutes along with notifying the RN of abnormal findings. 4. A review of the clinical record for Patient #4 was reviewed. 10 treatment records dated 07/04/2025 through 07/25/2025 evidenced the following: Treatment sheet dated 07/07/2025, a blood pressure and pulse check at 7:31 AM by PCT 4. PCT 4 completed the next blood pressure and pulse check at 8:02 AM. LPN 2 completed a blood pressure and pulse check at 9:03AM, and PCT 4 completed the next blood pressure and pulse check at 10:03 AM. During an interview on 07/28/2025 at 1:45 PM, PCT 4 communicated the process for monitoring patients during dialysis treatment to include safety checks, blood pressure, and pulse verification and documentation, every 30 minutes. 5. A review of the clinical record for Patient #5 was reviewed. 10 treatment records dated 07/05/2025 through 07/26/2025 evidenced the following: Treatment sheet dated 07/05/2025, a blood pressure and pulse check at 11:30 AM by PCT 15. PCT 15 completed the next blood pressure and pulse check at 1:08 PM. Treatment sheet dated 07/10/2025, a blood pressure and pulse check at 9:07 AM by PCT 4. RN 6 completed the next blood pressure and pulse check at 10:01 AM. Treatment sheet dated 07/22/2025, a blood pressure and pulse check at 9:21 AM by RN 4. LPN 2 completed the next blood pressure and pulse check at 11:38 AM. 6. A review of the clinical record for Patient #7 was reviewed. 10 treatment records dated 07/05/2025 through 07/26/2025 evidenced the following: Treatment sheet dated 07/05/2025, a blood pressure and pulse check at 9:31 AM by PCT 5. RN 5 completed the next blood pressure and pulse check at 10:31 AM. Treatment sheet dated 07/12/2025, a blood pressure and pulse check at 8:32 AM by PCT 6. PCT 6 completed the next blood pressure and pulse check at 9:33 AM. Treatment sheet dated 07/19/2025, a blood pressure and pulse check at 9:00 AM by PCT 6. PCT 9 completed the next blood pressure and pulse check at 10:31 AM. 7. A review of the clinical record for Patient #8 was reviewed. 10 treatment records dated 07/04/2025 through 07/25/2025 evidenced the following: Treatment sheet dated 07/04/2025, a blood pressure and pulse check at 8:32 AM by PCT 11. PCT 11 completed the next blood pressure and pulse check at 9:32 AM. Treatment sheet dated 07/16/2025, a blood pressure and pulse check at 7:31 AM by PCT 12. PCT 12 completed the next blood pressure and pulse check at 8:30 AM. Treatment sheet dated 07/17/2025, a blood pressure and pulse check at 11:03 AM by PCT 13. PCT 13 completed the next blood pressure and pulse check at 12:02 PM. Treatment sheet dated 07/21/2025, a blood pressure and pulse check at 8:35 AM by PCT 11. PCT 4 completed the next blood pressure and pulse check at 10:46 AM. Treatment sheet dated 07/23/2025, a blood pressure and pulse check at 7:33 AM by PCT 2. PCT 11 completed the next blood pressure and pulse check at 8:34 AM. PCT 11 completed the next blood pressure and pulse check at 9:44 AM. 8. A review of the clinical record for Patient #9 was reviewed. 10 treatment records dated 07/04/2025 through 07/26/2025 evidenced the following: Treatment sheet dated 07/22/2025, a blood pressure and pulse check at 12:03 PM by PCT 2. RN 3 completed the next blood pressure and pulse check at 12:59 PM. Treatment sheet dated 07/26/2025, a blood pressure and pulse check at 2:29 PM by PCT 3. PCT 3 completed the next blood pressure and pulse check at 3:23 PM. 9. A review of the clinical record for Patient #10 was reviewed. 12 treatment records dated 06/30/2025 through 07/25/2025 evidenced the following: Treatment sheet dated 06/30/2025, a blood pressure and pulse check at 10:34 AM by PCT 9. PCT 5 completed the next blood pressure and pulse check at 11:33 AM. Treatment sheet dated 07/04/2025, a blood pressure and pulse check at 1:32 PM by PCT 10. PCT 7 completed the next blood pressure and pulse check at 2:31 PM. Treatment sheet dated 07/16/2025, a blood pressure and pulse check at 2:03 PM by PCT 10. LPN 2 completed the next blood pressure and pulse check at 2:57 PM. 10. A review of the clinical record for Patient #11 was reviewed. 10 treatment records dated 07/02/2025 through 07/25/2025 evidenced the following: Treatment sheet dated 07/04/2025, a blood pressure and pulse check at 9:25 AM by PCT 2. PCT 2 completed the next blood pressure and pulse check at 10:24 AM. PCT 2 completed the next blood pressure and pulse check at 12:08 PM. Treatment sheet dated 07/18/2025, a blood pressure and pulse check at 9:31 AM by PCT 1. PCT 1 completed the next blood pressure and pulse check at 10:30 AM. PCT 1 completed the next blood pressure and pulse check at 11:36 AM, and then again at 12:21 PM. Treatment sheet dated 07/25/2025, a blood pressure and pulse check at 11:32 AM by LPN 2. LPN 2 completed the next blood pressure and pulse check at 12:41 PM. 11. A review of the clinical record for Patient #12 was reviewed. 6 treatment records dated 07/07/2025 through 07/21/2025 evidenced the following: Treatment sheet dated 07/07/2025, a blood pressure reading of 87/26 and pulse 59 at 1:50 PM by PCT 7. PCT 7 documented the next blood pressure reading 93/75 and pulse 55 at 2:11 PM. PCT 7 completed the next blood pressure reading 107/44 and pulse 62 at 3:32 PM. There was no evidence the RN was notified of systolic blood pressures less than 100 mm/Hg. Treatment sheet dated 07/11/2025, a blood pressure and pulse check at 2:35 PM by PCT 5. PCT 5 completed the next blood pressure and pulse check at 3:32 PM. PCT 1 completed the next blood pressure and pulse check at 11:36 AM, and again at 12:21 PM. Treatment sheet dated 07/21/2025, a blood pressure and pulse check at 2:03 PM by PCT 5. PCT 2 completed the next blood pressure and pulse check at 3:11 PM. 12. A review of the clinical record for Patient #15 was reviewed. 10 treatment records dated 06/28/52025 through 07/26/2025 evidenced the following: Treatment sheet dated 07/01/2025, a blood pressure and pulse check at 9:03 AM by PCT 13. PCT 13 completed the next blood pressure and pulse check at 10:02 AM. Treatment sheet dated 07/05/2025, a blood pressure and pulse check at 8:33 AM by PCT 11. PCT 14 completed the next blood pressure and pulse check at 9:32 AM. Treatment sheet dated 07/08/2025, a blood pressure and pulse check at 9:02 AM by PCT 13. PCT 13 completed the next blood pressure and pulse check at 11:07 AM. Treatment sheet dated 07/22/2025, a blood pressure and pulse check at 9:02 AM by LPN 1. PCT 13 completed the next blood pressure and pulse check at 11:07 AM. Treatment sheet dated 07/26/2025, a blood pressure and pulse check at 7:02 AM by PCT 13. PCT 13 completed the next blood pressure and pulse check at 8:05 AM. During an interview on 07/30/2025, at 2:20 PM, RN 3 and RN 4 communicated safety checks to include blood pressure and pulse were to be completed every 30 minutes by direct care staff. RN 4 further indicated episodes of marked hypertension a blood pressure above 180/100 mm/Hg or hypotension a systolic blood pressures less than 100 mm/Hg were to be reported to the nursing staff for further investigation and treatment.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure the staff instructed the patients on the proper use of hand hygiene after holding their access with a gloved hand during 3 of 4 post-dialysis observations. (Employees: PCT 3 (3 times)) (Patients: #11, 19, and 25) Findings Include: 1. A review of a Fresenius Kidney Care policy dated 11/06/2023, “Hand Hygiene,” indicated but was not limited to, “Purpose: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross-contamination. Responsibility: All staff, patients ... Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content ... Hand Hygiene: Patients: Patients should perform hand hygiene if able, prior to and after each dialysis treatment ... “ 2. On 03/17/2025 at 9:25 AM, two signs, one in English and the other in Spanish, were reviewed on the wall above the scale of the treatment area entrance. The signs stated, “Germs are all around you. Stay healthy, wash your hands.” During an interview on 03/17/2025 at 12:45 PM, when queried regarding infection control practices with gloves and hand hygiene, PCT 2 confirmed anytime gloves are removed hand hygiene should have been completed for staff or patients. 3. During an observation on 03/17/2025 at 2:25 PM, PCT 3 was observed assisting Patient #25 after the patient held their left vascular access site with a right gloved hand at Station #23. The patient obtained their weight, provided the weight slip to PCT 3, and left the treatment area. Patient #25 was not instructed or offered hand hygiene prior to leaving the treatment floor. 4. During an observation on 03/17/2025 at 3:05 PM, PCT 3 was observed assisting Patient #11 after the patient held their left vascular access site with a right gloved hand at Station #26. The PCT removed Patient #11’s glove and assisted the patient to the scale and their wheelchair after obtaining Patient #11’s weight. Patient #11 was not instructed or offered hand hygiene prior to leaving the treatment floor. During an interview on 03/18/2025 at 12:10 PM, PCT 6 indicated after the patients held their access with a gloved hand post-dialysis treatment, they were to be offered hand sanitizer. 5. During an observation on 03/18/2025 at 12:15 PM, PCT 3 was observed assisting Patient #19 after the patient held their left vascular access site with a right gloved hand at Station #7. The patient obtained their weight, provided the weight slip to PCT 3, and left the treatment area. Patient #19 was not instructed or offered hand hygiene prior to leaving the treatment floor. During an interview on 03/18/2025 at 12:30 PM, when queried regarding infection control practices regarding hand hygiene for patients post dialysis treatment, PCT 3 indicated the patients were to wash their hands, or we were to offer hand sanitizer. PCT 3 further stated, “I used to. We need to get back into that practice. We need to get better at that.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to ensure the proper storage of supplies without risk of exposure to contaminants in 2 of 3 observations. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 05/05/2021, titled “General Cleanliness and Infection Control Guidelines,” indicated but was not limited to, “ ... The purpose of this policy is to provide guidance for the FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors ... Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station ... “ 2. On 03/17/2025 at 9:30 AM, signs on the wall box shelves surrounding the treatment area were reviewed. The signs stated, “No items on back counter.” 3. On 03/17/2025 at 9:30 AM, during the Flash Tour of the treatment floor observed an arm cushion on the wall unit shelf behind Station #7 and a plastic container of hand sanitizer behind Station #4. 4. On 03/17/2025 at 3:45 PM, observed the following: a blue barrier on top of the dialysis machine at Station #27, a dialyzer, and tubing on the top of the dialysis machine at Station #28, a blue barrier wrapped around supplies used for disconnection of dialysis on the dialysis machine at Station #29, and a pile of gloves on the dialysis machine at Station #30. During an interview on 03/17/2025 at 3:45 PM, when queried regarding supplies being on the dialysis machines, PCT 3 stated, “No, nothing is to be on top of the dialysis machines.” 5. On 03/17/2025 at 3:46 PM, observed a patient’s pink jacket behind Station #29. During an interview on 03/17/2025 at 3:50 PM, when queried regarding the jacket on the wall unit shelf, PCT 2 stated, “No, it should not be on the wall unit box shelf.””

“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: 44232 Based on record review and interview, the facility failed to ensure the RN completed pre-dialysis assessments for 3 (Patients: #1, 2, and 3) of 5 records reviewed and failed to ensure direct patient care staff monitored the patients during their dialysis treatment within the timelines to ensure patient safety in 5 of 5 records reviewed. (Patients: #1, 2, 3, 4, and 5) Findings Include: 1. A review of a Fresenius Kidney Care policy dated 05/01/2023, titled “Patient Assessment and Monitoring” indicated but was not limited to “The purpose of this policy is to provide guidance ... direct care staff on assessment and monitoring patients before, during and after treatment ... During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations ... “ 2. A review of a Fresenius Kidney Care policy dated 11/06/2023, titled “Nursing Supervision and Delegation” indicated but was not limited to “ ... The registered nurse must evaluate each patient preferably within an hour or according to state requirements ... “ 3. A review of the medical record for Patient #1 contained treatment sheets from 02/21/2025 through 03/14/2025 evidenced the following: Treatment sheet dated 03/03/2025, a blood pressure and pulse check at 6:42 PM by PCT 10. RN 2 completed the next blood pressure and pulse check at 7:37 PM. Treatment sheet dated 03/07/2025, a blood pressure and pulse check at 5:00 PM by PCT 10. RN 2 completed the next blood pressure and pulse check at 6:36 PM. Treatment sheet dated 03/10/2025, evidenced Patient #1’s dialysis treatment started at 3:16 PM, RN 2 conducted their nursing assessment at 4:56 PM. Treatment sheet dated 03/14/2025, a blood pressure and pulse check at 4:40 PM by PCT 4. PCT 9 completed the next blood pressure and pulse check at 5:32 PM. During an interview on 03/18/2025 at 11:45 AM, PCT 4 confirmed patients were to have blood pressure, pulse, and safety checks every 30 minutes or every 15 minutes for low or high blood pressures noted during dialysis treatment. 4. A review of the medical record for Patient #2 contained treatment sheets from 02/21/2025 through 03/14/2025 evidenced the following: Treatment sheet dated 02/28/2025, evidenced Patient #2’s dialysis treatment started at 6:02 AM, RN 4 conducted their nursing assessment at 10:36 AM. Treatment sheet dated 03/03/2025, a blood pressure and pulse check at 9:02 AM by PCT 11. PCT 12 completed the next blood pressure and pulse check at 10:14 AM. Treatment sheet dated 03/03/2025, evidenced Patient #2’s dialysis treatment started at 6:17 AM, RN 5 conducted their nursing assessment at 9:38 AM. During an interview on 03/18/2025 at 11:50 AM, when queried regarding the timeline of the RN’s initial patient assessment completion, RN 2 indicated the patient initial assessment should had been completed within an hour of the patient starting dialysis treatment. 5. On 03/18/2025, the clinical record for Patient #3 was reviewed. 10 treatment records dated 02/24/2025 through 03/14/2025 evidenced the following: Treatment sheet dated 02/26/2025, a blood pressure and pulse check at 9:32 AM by RN 6. The RN completed the next blood pressure and pulse check at 11:08 AM. Treatment sheet dated 02/28/2025, a blood pressure and pulse check at 9:32 AM by PCT 13. PCT 11 completed the next blood pressure and pulse check at 9:32 AM. PCT 11 completed the next blood pressure and pulse check at 11:06 PM. Treatment sheet dated 03/03/2025, evidenced Patient #3’s dialysis treatment started at 7:03 AM, RN 1 conducted their nursing assessment at 3:40 PM. Treatment sheet dated 03/03/2025, a blood pressure and pulse check at 10:04 AM by RN 1. PCT 12 completed the next blood pressure and pulse check at 11:06 AM. Treatment sheet dated 03/05/2025, a blood pressure and pulse check at 9:01 AM by PCT 12. PCT 12 completed the next blood pressure and pulse check at 10:00 AM. Treatment sheet dated 03/12/2025, a blood pressure and pulse check at 10:02 AM by PCT 14. PCT 13 completed the next blood pressure and pulse check at 10:51 AM. Treatment sheet dated 03/14/2025, evidenced Patient #3’s dialysis treatment started at 6:54 AM, RN 1 conducted their nursing assessment at 8:21 AM. During an interview on 02/18/2025 at 11:35 AM, RN 1 confirmed initial assessments were to had been completed by the RN within one hour of the patient’s start of dialysis treatment. 6. On 03/18/2025 the clinical record for Patient #4 was reviewed. 10 treatment records dated 0/21/2025 through 03/14/2025 evidenced the following: Treatment sheet dated 02/28/2025, a blood pressure and pulse check at 8:37 AM by PCT 13. PCT 11 completed the next blood pressure and pulse check at 9:47 AM. During an interview on 03/17/2025 at 12:45 PM, PCT 2 confirmed patient safety checks are to be completed, including blood pressures every 30 minutes during the patient’s dialysis treatment. 7. On 03/18/2025, the clinical record for Patient #5 was reviewed. 10 treatment records dated 02/21/2025 through 03/14/2025 evidenced the following: Treatment sheet dated 03/05/2025, a blood pressure and pulse check at 9:03 AM by PCT 3. PCT 3 completed the next blood pressure and pulse check at 10:05 AM. Treatment sheet dated 03/10/2025, a blood pressure and pulse check at 8:32 AM by PCT 2. PCT 1 completed the next blood pressure and pulse check at 10:03 AM. PCT 1 completed the next blood pressure and pulse check at 10:47 AM. Treatment sheet dated 03/14/2025, a blood pressure and pulse check at 9:01 AM by PCT 4. PCT 4 completed the next blood pressure and pulse check at 10:03 AM. During an interview on 03/18/2025 at 12:30 PM, PCT 3 indicated the staff were to monitor and document safety checks, including blood pressures every 30 minutes during the patient’s dialysis treatment, and report any issues to the RN.”

“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: 44232 Based on record review and interview, the facility failed to ensure initial nursing assessments were completed prior to the initiation of the first dialysis treatment for 1 of 1 newly admitted clinical records reviewed. (Patient: #5) Findings Include: 1. A review of a Fresenius Kidney Care policy dated 07/03/2025, titled “Comprehensive Interdisciplinary Assessment and Plan of Care” indicated but was not limited to, “A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs . ... “ 2. A review of the clinical record for Patient #5, admission date 02/07/2025, contained an initial treatment sheet dated 02/07/2025. The treatment sheet indicated Patient #5’s treatment had been initiated at 6:53 AM, and RN 4 completed their nursing assessment at 7:39 AM. The clinical record failed to evidence the initial RN assessment had been performed prior to the initiation of dialysis treatment. During an interview on 03/18/2025 at 11:35 AM, when queried regarding the process for the first nursing assessment of a new dialysis patient, RN 1 indicated the RN should have completed the nursing assessment prior to the patient’s initiation of dialysis treatment.”

“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: 44232 Based on record review and interview, the facility failed to ensure they maintained complete and accurate clinical records by obtaining a patient signed AMA (against medical advice) forms for 3 of 5 patient records reviewed. (Patients: #1, 2 and 3) Findings Include: 1. A review of a Fresenius Kidney Care policy dated 11/07/2022, titled “Early Termination or Arriving Late for Treatment” indicated but was not limited to, “The purpose of this policy is to provide guidelines for staff when patients ... request early termination of treatment ... The RN who evaluates the patient must document the rationale for early termination ... The RN is responsible to notify the physician, and document on the “AMA”, or Against Medical Advice form ... Against Medical Advice forms are signed by the patient and witnessed by the supervising nurse ... Signed with each early termination event and filed in the patient’s medical record ... “ 2. On 03/18/2025 the clinical record for Patient #1 was reviewed. 7 treatment records dated 02/21/2025 through 03/14/2025 evidenced the following: A review of the post-treatment prescription information dated 02/21/2025 indicated a prescribed duration time of 4 hours. The treatment duration time was 2 hours and 57 minutes. Patient #1 was taken off treatment 1 hour and 3 minutes early. The record indicated Patient #1 requested early termination of treatment. The record failed to provide evidence of RN documentation of the rationale for early termination of dialysis treatment and an obtained patient-signed AMA form. A review of the post-treatment prescription information dated 03/07/2025 indicated a prescribed duration time of 4 hours. The treatment duration time was 2 hours and 56 minutes. Patient #1 was taken off treatment 1 hour and 4 minutes early. The record indicated Patient #1 requested early termination of treatment. The record failed to provide evidence of RN documentation of the rationale for early termination of dialysis treatment and an obtained patient-signed AMA form. 3. On 03/18/2025 the clinical record for Patient #2 was reviewed. 10 treatment records dated 02/24/2025 through 03/14/2025 evidenced the following: A review of the post-treatment prescription information dated 03/10/2025 indicated a prescribed duration time of 4 hours. The treatment duration time was 2 hours and 45 minutes. Patient #2 was taken off treatment 1 hour and 15 minutes early. The record indicated Patient #2 requested early termination of treatment. The record failed to provide evidence of RN documentation of the rationale for early termination of dialysis treatment and an obtained patient-signed AMA form. 4. On 03/18/2025 the clinical record for Patient #3 was reviewed. 10 treatment records dated 02/24/2025 through 03/14/2025 evidenced the following: A review of the post-treatment prescription information dated 02/21/2025 indicated a prescribed duration time of 4 hours. The treatment duration time was 2 hours and 44 minutes. Patient #3 was taken off treatment 1 hour and 16 minutes early. The record failed to provide evidence of RN documentation of the rationale for early termination of dialysis treatment and an obtained patient-signed AMA form. A review of the post-treatment prescription information dated 03/05/2025 indicated a prescribed duration time of 4 hours. The treatment duration time was 3 hours and 26 minutes. Patient #3 was taken off treatment 34 minutes early. The record failed to provide evidence of RN documentation of the rationale for early termination of dialysis treatment and an obtained patient-signed AMA form. A review of the post-treatment prescription information dated 03/07/2025 indicated a prescribed duration time of 4 hours. The treatment duration time was 2 hours and 43 minutes. Patient #3 was taken off treatment 1 hour and 17 minutes early. The record failed to provide evidence of RN documentation of the rationale for early termination of dialysis treatment and an obtained patient-signed AMA form. A review of the post-treatment prescription information dated 03/10/2025 indicated a prescribed duration time of 4 hours. The treatment duration time was 3 hours and 24 minutes. Patient #3 was taken off treatment 36 minutes early. The record failed to provide evidence of RN documentation of the rationale for early termination of dialysis treatment and an obtained patient-signed AMA form. During an interview on 03/18/2025 at 11:40 AM, RN 1 explained the process for patients requesting early termination of their dialysis treatment. RN 1 confirmed staff must complete AMA forms, have the patient sign them, document the education provided, and note the patient’s reasons for requesting early termination. This applies even if the patient wants to end their dialysis treatment just five minutes earlier than the scheduled duration. 6. During an interview on 03/18/2025 at 12:35 PM, when requested the AMA forms for Patient #1, 2, and 3, the Director of Operations stated, “I have no AMAs for those patients.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 47343 Based on observation, record review, and interview, the facility failed to ensure the proper storage of supplies for 3 of 3 treatment room observations. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 11/04/2024, titled “General Cleanliness and Infection Control Guidelines,” indicated but was not limited to, “ ... The purpose of this policy is to provide guidance for the FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors ... Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station ... “ 2. During the flash tour on 02/20/2025 at 11:05 AM, the following treatment floor observations were made: An observation at Station 25 evidenced an empty Hemodialysis (a procedure where it filters waste and excess fluids when the kidneys were unable to filter it out of the body) blood tubing bag on top of the dialysis machine. An observation at Station 24 evidenced a tape roll on top of the dialysis machine. An observation at Station 6 evidenced a Citra Clean bottle on top of the wall box behind the chair. An observation at Station 36 evidenced an arm chair cushion on the wall box behind the chair. 3. On 02/20/2025 at 2:37 PM, the following treatment floor observations were made: An observation at Station 17 evidenced a black spiral cord on the wall box behind the chair. An observation at Station 15 evidenced a patient’s coat on the wall box behind the chair. An observation at Station 14 evidenced a television remote on the wall box. An observation at Station 12 evidenced a gray, plastic, circular piece, the size of the palm on a hand, on the wall box. An observation at Station 7 evidenced a gray, plastic, circular piece, the size of the palm on a hand, on the wall box. An observation at Station 32 evidenced a Bicarbonate bag on top of the dialysis machine. 51279 4. On 02/20/2025 at 10:56 AM, the following flash tour treatment floor observations were made: An observation of a sign posted on the chaise wall box indicated “NO ITEMS ON BACK COUNTER”. An observation of a black cord and a blood pressure cuff on the chaise wall box behind Station #32. An observation of a gray cushion on the chaise wall box behind Station #30. An observation of a gray cushion on the chaise wall box between Station #27 and 28. An observation of a blood pressure cuff on the chaise wall box behind Station #27. An observation of a gray cushion on the chaise wall box behind Station #12. An observation of a black cord on the chaise wall box behind Station #8. An observation of a blood pressure cuff and gray cushion on the chaise wall box behind Station #7. An observation of a clear bottle labeled “Citric Acid” on the chaise wall box between Station #5 and Station #6. An observation of a blood pressure cuff on the chaise wall box behind Station #19. During an interview on 02/20/2025 at 11:23 AM, LPN 5 indicated that there should be nothing placed on the chaise wall box, and only caps from the dialyzers should be placed on top of the dialysis machine.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 51279 Based on observation, record review, and interview the facility failed to ensure sharps (objects with sharp points or edges that potentially cause injury through puncture or cuts, example needles, scalpels, syringes etc.) were properly disposed of for 1 of 2 trash cans at the nurses station attached to handwashing sink B. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 11/04/2024, titled “General Cleanliness and Infection Control Guidelines” indicated but was not limited to, “Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: clearly identifiable as a sharps container ... Regulated medical waste shall be placed in a container that is ... closeable, leak proof and labeled and/or color coded” 2. On 02/20/2025 at 12:08 PM, the following treatment floor observations were made: An observation of two syringes with needles attached in the trash can next to the handwashing sink B. During an interview on 02/20/2025 at 12:36 PM, PCT 6 indicated sharps should go in the “bio bin”. During an interview on 02/20/2025 at 12:45 PM, PCT 11 indicated sharps should go in the biohazard bin. During an interview on 02/20/2025 at 4:36 PM, the Director of Operations 1 indicated “we can’t do that, there will be education on that,” when queried about sharps being observed in the trash.”

“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: 47343 Based on observations and interviews, the facility failed to ensure all expired medications were removed from 1 of 2 code carts on the treatment floor. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 02/06/2023 titled “Medication Preparation and Administration” indicated but was not limited to, “ ... Monitoring Expired Medications: Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded ...” 2. During a review of the code cart in front of Station 25 on 02/20/2025 at 11:17 PM, Diphenhydramine Hydrochloride 50 milligram (mg)/ milliliter (ml) box had an expiration date of 10/31/2024, Naloxone Hydrochloride 0.4 mg/ml had an expiration date of 11/2024, and Adrenaline 1mg/ml vial had an expiration date of 01/2025. The facility failed to ensure expired medications were disposed. A review of the Automated External Defibrillator checklist evidenced the code cart was checked daily. 3. During an interview with LPN 1 on 02/20/2025 at 11:20 AM, they indicated they thought the code cart was checked monthly. They revealed expired medications were supposed to be disposed and the Facility Administrator would be informed. 4. During an interview with the Director of Operations (DO) on 02/20/2025 at 2:29 PM, they explained how the code cart was to be reviewed daily by the nurse who was assigned to the pod and expired medications were to be discarded.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 47343 Based on record review and interview, the facility failed to ensure an internal grievance was documented for 1 of 1 patient complaints. (Patient #4) Findings Include: 1. A review of a Fresenius Kidney Care policy dated 04/04/2014, titled “Patient Grievance Procedure” indicated but was not limited to, “ ... Follow the steps below when a patient or patient representative has a grievance: ... The CM ensure the following details are completed in the Quality Assessment and Performance Improvement (QAI) Patient Grievance Status Report: Date grievance received ... Intake Person, Patient Initials, Nature of the grievance, Findings of the investigation ... Resolution and any corrective actions taken ... Note: Even if a patient’s grievance is resolved quickly, the CM must document the complaint and the actions taken to resolve it ...” 2. A review of the “Patient Grievance Report” dated 02/20/2024 to 02/20/2025 failed to evidence the complaint made by Patient #4 to MSW 1. The facility failed to ensure all complaints were investigated, documented, and a resolution was determined. 3. During an interview with the Complainant, Patient #4 on 02/20/2025 at 11:10 AM, they indicated the automatic front door’s glass window was boarded up for two months and it was off of the track. They explained how the glass was broken and could have hurt someone. Patient #4 indicated they informed the agency of their concern. They revealed the door had been fixed for about a month. They indicated they had no further issues and if they had further complaints, they knew how to make one. 4. During an interview with the MSW on 02/20/2025 at 1:25 PM, they explained how Patient #4 had approached them and indicated the wood replacement for the glass in the door was embarrassing. They indicated the complaint was not in the complaint log because it was “not a jeopardy” to the patient’s treatment. They explained all complaints were to be reported and recorded. They revealed the process of when they received a complaint, they would send an electronic message to the Medical Director, the Director of Operations (DO), or whoever would be in charge of the complaint. They indicated they would document the complaint in their electronic medical record and the complaints were reviewed monthly by the Quality Assurance team. They explained how SW 2 would participate in the meetings and the team would come to a resolution and relay it back to the complainant. 5. During an interview with the DO on 02/20/2025 at 4:35 PM, they indicated the complaint that Patient #4 had made about the front door being broken should have been documented in the complaint log.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure the staff instructed the patients on the proper use of hand hygiene after holding their access with a gloved hand during 3 of 6 termination of treatment observations. (Patients: #24, 25, and 27) Findings Include: 1. A policy dated 11-06-2023, “Hand Hygiene,” indicated but was not limited to, “Purpose: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross-contamination. Responsibility: All staff, patients ... Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content ... Hand Hygiene: Patients: Patients should perform hand hygiene if able, prior to and after each dialysis treatment ... “ 2. On 05-23-2024 at 1:50 PM, a sign posted on the wall above the scale of the entrance to the treatment area was reviewed. The sign stated, “Please Wash Your Hands. Help Us Keep You Safe.” 3. During an interview on 05-20-2024 at 3:35 PM, when queried regarding staff offering hand hygiene after their treatment, Patient #23 confirmed the staff did not offer hand hygiene. 4. During an observation on 05-20-2024 at 3:40 PM, PCT 6 was observed assisting Patient #24 after the patient held their left vascular access site with a right gloved hand at Station #29. Patient #24 was not instructed or offered hand hygiene prior to leaving the treatment floor. During an interview on 05-20-2024 at 3:45 PM, Patient #24 confirmed the staff do not offer hand hygiene prior to them leaving the treatment floor. 5. During an observation on 05-21-2024 at 1:16 PM, PCT 7 was observed assisting Patient #27 after the patient held their right vascular access site with a left gloved hand at Station #6. Patient #27 was not instructed or offered hand hygiene prior to leaving the treatment floor. 6. During an observation on 05-22-2024 at 10:10 AM, RN 9 was observed assisting Patient #25 after the patient held their right vascular access site with a left gloved hand at Station #36. Patient #25 was not instructed or offered hand hygiene prior to leaving the treatment floor. During an interview on 05-23-2024 at 5:40 PM, PCTs 4 and 10 indicated the patients were to be offered hand hygiene after holding the access prior to leaving the treatment floor.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to minimize the risk of occupational exposure to needlesticks with overfilled sharp containers at the treatment stations and nurses’ station for 1 of 1 the stand alone in-center facilities. Findings include: 1. A review of a policy dated 11-06-2023, “Exposure Categories and Determination” indicated but was not limited to, “ ... Direct patient care staff who are potentially exposed to injuries from contaminated sharps ... “ 2. A review of a policy dated 05-02-2022, “Infection Control Overview” indicated but was not limited to, “ ... FMC is committed to abiding by laws and regulations of the Occupational Safety and Health Administration (OSHA) ... Safe and efficient handling and disposal of waste and contaminants ... Engineering Controls: controls (e.g. sharps disposal containers, self-sheathing needles ... ) isolate or remove the bloodborne pathogens hazard from the workplace ... ) 3. A review of a policy dated 04-05-2021, “General Cleanliness and Infection Control Guidelines” indicated but was not limited to, “ ... All containers for storage of needles/sharps shall be replaced on a regularly scheduled basis or when no more than 2/3 to 3/4 full ... “ 4. During a flash tour on 05-20-2024 at 10:10 AM, overfilled sharps containers were observed on the treatment floor attached to the dialysis machines at Stations #25 and #26. 5. During an observation on 05-20-2024 at 10:41 AM, observed at the Nurses’ station, and Stations #10, #27, #28, and #32 overfilled sharp containers. During an interview on 05-20-2024 at 10:41 AM, the registered nurse (RN) confirmed the sharps container at the nurses’ station was overfilled and needed replaced. 6. During an observation on 05-21-2024 at 1:00 PM, observed at Stations #30, #31, #32, and #33 overfilled sharp containers. During an interview on 05-21-2024 at 1:50 PM, the Patient Care Technician (PCT) 2 indicated the sharps containers should be emptied by the PCT who works that track. PCT 2 further indicated these had not been emptied.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 44232 Based on record review and interview, the facility failed to ensure all employees were vaccinated against Hepatitis B (Hep B) or completed a Hep B declination of refusal for 2 of 6 active personnel files reviewed. (Employees: Facility Administrator (FA) and Licensed Practical Nurse (LPN) 1) Findings Include: 1. A review of a policy dated 04-05-2021, “Employee Requirements for Testing and Vaccination for Hepatitis B” indicated but was not limited to, “ ... The Hepatitis B vaccine shall be offered to all employees upon hire or rehire ... Hepatitis B vaccination status shall be documented in the employee’s vaccination records including: signed consent or declaration forms, dates of all the hepatitis B vaccinations, documentation of having received the vaccination information statements ... “ 2. A review of the personnel file for FA, date of hire 01-08-2024, failed to evidence a Hep B declination of refusal, a Hep B antibody test, or dates of the Hep B vaccine series. During an interview on 05-23-2024 at 10:15 AM, the Regional Director of Operations/Interim Regional Vice President, Corp 2, confirmed the FA’s personnel file failed to contain the required documentation of their Hep B vaccination status. 3. A review of the personnel file for LPN 1, date of hire 12-05-2022, failed to evidence a Hep B declination of refusal, a Hep B antibody test, or dates of the Hep B vaccine series. During an interview on 05-23-2024 at 10:15 AM, Corp 2, confirmed LPN 1’s personnel file failed to contain the required documentation of their Hep B vaccination status.”

“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: 44232 Based on record review and interview, the facility failed to ensure all employees were tested for tuberculosis (TB) in 4 of 6 personnel records reviewed. (Employees: Facility Administrator (FA), Patient Care Technician (PCT) 1 and 2, and Licensed Practical Nurse (LPN) 1) Findings Include: 1. A review of a policy dated 02-05-2024, “Employee Tuberculosis Testing” indicated but was not limited to, “ ... TB testing using the two-step tuberculin skin test (TST) method is required upon hire ... If a new employee has a documented baseline TST result within the previous 12 months, a single TST can be administered ... If an employee provides Interferon-Gamma Release Assay (IGRA) results ... results must be within the last 12 months ... A recent chest x-ray with the previous 6 months can be used as evidence ... “ 2. A review of the personnel file for the FA, date of hire 01-08-2024, failed to evidence a chest x-ray, 2-step TST, or IGRA results. 3. A review of the personnel file for PCT 1, date of hire 11-28-2016, failed to evidence a chest x-ray, 2-step TST, or IGRA results. 4. A review of the personnel file for PCT 2, date of hire 07-25-2022, failed to evidence a chest x-ray, 2-step TST, or IGRA results. 5. A review of the personnel file for LPN 1, date of hire 12-05-2022, failed to evidence a chest x-ray, 2-step TST, or IGRA results. During an interview on 05-23-2024 at 10:15 AM, the Regional Director of Operations/Interim Regional Vice President, Corp 2, confirmed during the personnel record review the personnel records were missing TB testing documentation.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure the staff monitored and discarded the liquid nutrition within 3 months of opening at 1 of 1 medication stations. Findings Include: 1. A review of a policy dated 02-06-2023, “Medication Preparation and Administration” indicated but was not limited to, “ ...Expiration dates for all stored medications are to be monitored on a monthly basis ... Patient specific bulk containers of oral liquids ... expiration date/ maximum time period for use per manufacturer’s expiration date ... “ 2. A review of the Liquacel ( a liquid protein supplement) container’s label for directions indicated to use the product within 3 months of opening. During a flash tour observation on 05-20-2024 at 10:10 AM, observed on the top of the medication station were 5 open 32-ounce containers of Liquacel (a liquid protein supplement). Grape Liquacel with date opened 11-15-2023, Ginger Ale with date opened 10-05-2023, the and the Peach Mango Liquacel with date opened 10-19-2023. During an interview on 05-20-2024 at 10:41 AM, Registered Nurse (RN) 2 indicated they were to use the Liquacel within 1 month of it being opened. RN 2 reviewed the container of Liquacel and confirmed that the containers must be used within 3 months of opening.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure a safe and comfortable environment in 4 of 4 observations at the facility’s entrance. Findings include: 1. A review of a policy dated 04-05-2021, “General Cleanliness and Infection Control Guidelines” indicated but was not limited to, “The purpose of this policy is to provide guidance for FKC staff on the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. 2. On 05-20-2024 at 9:44 AM, observed upon entering the front doors piles of cigarette butts, used paper towels, and used 3 dirty blue surgical masks on the left side of the entry door. 3. On 05-21-2024 at 8:30 AM, observed upon entering the front doors piles of cigarette butts, used paper towels, and used 3 dirty blue surgical masks on the left side of the entry door. 4. On 05-22-2024 at 9:25 AM, observed upon entering the front doors piles of cigarette butts, used paper towels, and used 3 dirty blue surgical masks on the left side of the entry door. During an interview on 05-22-2024 at 11:11 AM, Patient #4 confirmed the facility had trash outside the front entrance door. 5. On 05-23-2024 at 7:55 AM, observed upon entering the front doors piles of cigarette butts, used paper towels, and used 3 dirty blue surgical masks on the left side of the entry door. During an interview on 05-23-2024 at 2:00 PM, the Facility Administrator (FA) was not sure who should clean the facility grounds, the housekeeping staff or the lawn care company. The management team will verify and follow up.”

“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: 44232 Based on record review and interview, the facility failed to ensure patients were made aware of the grievance process, promptly acknowledged and reported all patient grievances, investigated and addressed the patient’s grievance, and reported back to the patient with a resolution for 1 of 1 stand alone in-center facilities. Findings include: 1. A review of a policy dated 04-04-2014, “Patient Grievance Procedure” indicated but was not limited to, “ ... To comply with federal and state regulations ... To inform patients, or patient representative of the FMCNA Grievance Process ... Educating patient on ... Promptly acknowledge the patient/family members concern ... Assisting and assessing and resolving patient grievances ... Completing the Patient Grievance status report ...provide periodic updates to the patient ... “ 2. A review of the Patient Grievance Report dated 12-27-2023 through 05-20-2024 revealed patient grievances related to staff care, attitude, chair location, treatment denial due to the patient’s unstable condition, and missing phone. Requested the staff and patient grievances regarding staffing. During an interview on 05-20-2024 at 3:00 PM, when asked about staff and patient complaints about staffing and shortened treatments, the Facility Administrator (FA) and Diirectior of Operations (DO), indicated they did not have those. 3. During an interview on 05-21-2024 at 9:30 AM, Patient #3 confirmed they had filed a grievance regarding care and staffing. Patient #3 indicated they had no further problems with care and stated, “They do their best, but they need help.” 4. During an interview on 05-22-2024 at 5:15 PM, Patient #5 confirmed their treatments were shorted to 3 hours a couple of weeks ago. When asked if they complained to the management staff, Patient #5 indicated the manager was not available for calls, returned calls, or did not know who the manager was to file a complaint. 5. During the Daily Conference on 05-20-2024 at 4:15 PM, the FA confirmed they had received complaints from staff and patients and did not complete grievance reports.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 44232 Based on record review and interview, the facility failed to ensure the patient’s targeted estimated dry weight (EDW) was met post-treatment and failed to ensure the Registered Nurse (RN) had notified the physician in 6 of 6 records reviewed. (Patients: #2, 3, 4, 5, 6, and 7) Findings Include: 1. A review of a policy dated 09-07-2021, “Volume Management in ESRD (End Stage Renal Disease) Patients on Hemodialysis” indicated but was not limited to, “ ... EDW is used to calculate the target weight removal ... If any the following patient clinical conditions occur ... consult with provider for appropriate fluid interventions: ... Unable to achieve EDW ... “ 2. A review of a Fresenius Medical Care Job description titled “Staff Registered Nurse” indicated but was not limited to “Provides safe and effective delivery of care to patients with ESRD ... Identifies and communicates patient related issues to Team Leader or physician ... “ 3. The clinical record for Patient #2 was reviewed on 05-21-2024 and evidenced a document titled “Current Orders Report,” which indicated orders dated 12-28-2023 for In-center Hemodialysis treatments every Tuesday, Thursday, and Saturday for 4 hours with an EDW of 122 kilograms (kg). A review of the treatment sheets for Patient #2 evidenced the following with no documentation that the nurse notified the physician of target EDW not met within 1 kg: 05-09-2024 Target Weight=122 kg Post-weight=128.70 kg 05-16-2024 Target Weight=122 kg Post-weight=127.00 kg 4. The clinical record for Patient #3 was reviewed on 05-22-2024 and evidenced a document titled “Current Orders Report” which indicated orders dated 12-28-2023 for In-center Hemodialysis treatments every Tuesday, Thursday, and Saturday, for 4 hours with an EDW of 99.5 kilograms (kg). A review of the treatment sheets for Patient #3 evidenced the following with no documentation that the nurse notified the physician of target EDW not met within 1 kg: 05-02-2024 Target Weight=99.5 kg Post-weight=100.10 kg 05-16-2024 Target Weight=99.5 kg Post-weight=100.50 kg 05-18-2024 Target Weight=99.5 kg Post-weight=100.20 kg 5. The clinical record for Patient #4 was reviewed on 05-23-2024 and evidenced a document titled “Current Orders Report,” which indicated orders dated 02-28-2024 for In-center Hemodialysis treatments every Monday, Tuesday, and Friday, for 5 hours and 45 minutes with EDW of 196 kilograms (kg). A review of the treatment sheets for Patient #4 evidenced the following with no documentation that the nurse notified the physician of target EDW not met within 1 kg: 04-24-2024 Target Weight=196 kg Post-weight=197.90 kg 04-26-2024 Target Weight=196 kg Post-weight=197.10 kg 04-29-2024 Target Weight=196 kg Post-weight=199.50 kg 05-01-2024 Target Weight=196 kg Post-weight=198.50 kg 05-03-2024 Target Weight=196 kg Post-weight=198.10 kg 05-06-2024 Target Weight=196 kg Post-weight=202.50 kg 05-08-2024 Target Weight=196 kg Post-weight=202.70 kg 05-10-2024 Target Weight=196 kg Post-weight=200.60 kg 05-15-2024 Target Weight=196 kg Post-weight=204.50 kg 05-16-2024 Target Weight=196 kg Post-weight=201.40 kg 05-17-2024 Target Weight=196 kg Post-weight=203.70 kg 6. The clinical record for Patient #5 was reviewed on 05-22-2024 and evidenced a document titled “Current Orders Report” which evidenced orders dated 03-04-2024 for In-center Hemodialysis treatments every Monday, Wednesday, and Friday, for 4 hours with an EDW of 83.5 kg. A review of the treatment sheets for Patient #5 evidenced the following with no documentation that the nurse notified the physician of target EDW not met within 1 kg: 05-06-2024 Target Weight=83.5 kg Post-weight=84.5 kg 7. The clinical record for Patient #6 was reviewed on 05-23-2024 and evidenced a document titled “Current Orders Report” which evidenced orders dated 04-19-2024 for In-center Hemodialysis treatments every Monday, Wednesday, and Friday, for 3 hours and 45 minutes with an EDW of 50 kg. A review of the treatment sheets for Patient #6 evidenced the following with no documentation that the nurse notified the physician of target EDW not met within 1 kg: 05-15-2024 Target Weight=50 kg Post-weight=54.10 kg 05-17-2024 Target Weight=50 kg Post-weight=51.20 kg 8. The clinical record for Patient #7 was reviewed on 05-23-2024 and evidenced a document titled “Current Orders Report” which evidenced orders dated 04-24-2024 for In-center Hemodialysis treatments every Monday, Wednesday, and Friday, for 4 hours and 15 minutes with an EDW of 118 kilograms (kg). A review of the treatment sheets for Patient #7 evidenced the following with no documentation that the nurse notified the physician of target EDW not met within 1 kg: 04-26-2024 Target Weight=118.50 kg Post-weight=122.30 kg 05-03-2024 Target Weight=118.50 kg Post-weight=121.20 kg 05-08-2024 Target Weight=118.50 kg Post-weight=122.10 kg 05-15-2024 Target Weight=118.50 kg Post-weight=124.60 kg During an interview on 05-23-2024 at 1:45 PM, when queried when they notified the patient’s physician about EDW not being met after dialysis treatment, RN 1 indicated the nurses notified the patient’s physician of 1 kg or more.”

“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: 44232 Based on record review and interview, the facility failed to ensure direct patient care staff monitored the patients during their dialysis treatment per the facility policy in 6 of 6 records reviewed. (Patients: #2, 3, 4, 5, 6, and 7) Findings include: 1. A review of a policy dated 09-05-2023, “Patient Monitoring and Safety Checks During Hemodialysis Treatment” indicated but was not limited to, “ ... Monitor and document every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations ... “ 2. The clinical record for Patient #2 was reviewed on 05-21-2024. The treatment records between 04-27-2024 and 05-18-2024 evidenced the following: A. A review of the treatment record dated 04-30-2024 evidenced the Patient Care Technician (PCT) 9 started Patient #2’s treatment at 05:31 AM. The following patient safety check was completed by the PCT, who obtained Patient #2’s blood pressure, pulse, and machine safety check at 06:39 AM. 3. The clinical record for Patient #3 was reviewed on 05-22-2024. The treatment records between 04-27-2024 and 05-18-2024 evidenced the following: A. A review of the treatment record dated 05-11-2024 evidenced PCT 10 completed Patient #3’s blood pressure, pulse, and machine safety check at 09:30 AM. PCT 10 then completed the following patient safety check: obtained Patient #3’s blood pressure, pulse, and machine safety check at 10:20 AM. B. A review of the treatment record dated 05-14-2024 evidenced PCT 1 started Patient #3’s treatment at 06:30 AM. The PCT then completed the following patient safety check: obtained Patient #3’s blood pressure, pulse, and machine safety check at 07:35 AM. 4. The clinical record for Patient #4 was reviewed on 05-23-2024. The treatment records between 04-24-2024 and 05-17-2024 evidenced the following: A. A review of the treatment record dated 04-29-2024 evidenced that Registered Nurse (RN) 1 completed Patient #4’s blood pressure, pulse, and machine safety check at 10:07 AM. RN 1 then obtained Patient #4’s blood pressure, pulse, and machine safety check at 11:02 AM. B. A review of the treatment record dated 05-11-2024 evidenced PCT 12 completed Patient #4’s blood pressure, pulse, and machine safety check at 07:35 AM. PCT 9 then completed the following patient safety check: obtained Patient #4’s blood pressure, pulse, and machine safety check at 08:37 AM. C. A review of the treatment record dated 05-13-2024 evidenced PCT 9 completed Patient #4’s blood pressure, pulse, and machine safety check at 06:02 AM. PCT 13 then completed the following patient safety check: obtained Patient #4’s blood pressure, pulse, and machine safety check at 07:36 AM. D. A review of the treatment record dated 05-15-2024 evidenced RN 7 completed Patient #4’s blood pressure, pulse, and machine safety check at 10:02 AM. RN 7 then completed the following patient safety check: obtained Patient #4’s blood pressure, pulse, and machine safety check at 11:02 AM. 5. The clinical record for Patient #5 was reviewed on 05-22-2024. The treatment records between 04-26-2024 and 05-17-2024 evidenced the following: A. A review of the treatment record dated 04-26-2024 evidenced PCT 2 completed Patient #5’s blood pressure, pulse, and machine safety check at 17:34 PM. PCT 2 then completed the following patient safety check: obtained Patient #5’s blood pressure, pulse, and machine safety check at 18:32 PM. B. A review of the treatment record dated 05-01-2024 evidenced RN 3 completed Patient #5’s blood pressure, pulse, and machine safety check at 18:08 PM. RN 3 then completed the following patient safety check: obtained Patient #5’s blood pressure, pulse, and machine safety check at 20:04 PM. C. A review of the treatment record dated 05-13-2024 evidenced PCT 15 completed Patient #5’s blood pressure, pulse, and machine safety check at 17:39 PM. PCT 15 then completed the following patient safety check: obtained Patient #5’s blood pressure, pulse, and machine safety check at 18:33 PM. PCT 15 then completed the following patient safety check: obtained Patient #5’s blood pressure, pulse, and machine safety check at 19:00 PM, then again at 20:45 PM. D. A review of the treatment record dated 05-15-2024 evidenced PCT 14 completed Patient #5’s blood pressure, pulse, and machine safety check at 20:02 PM. PCT 14 then completed the following patient safety check: obtained Patient #5’s blood pressure, pulse, and machine safety check at 21:15 PM. E. A review of the treatment record dated 05-17-2024 evidenced PCT 10 completed Patient #5’s blood pressure, pulse, and machine safety check at 17:44 PM. PCT 10 then completed the following patient safety check: obtained Patient #3’s blood pressure, pulse, and machine safety check at 18:36 PM. 6. The clinical record for Patient #6 was reviewed on 05-23-2024. The treatment records between 04-26-2024 and 05-17-2024 evidenced the following: A. A review of the treatment record dated 05-17-2024 evidenced PCT 16 completed Patient #6’s blood pressure, pulse, and machine safety check at 17:02 PM. PCT 10 then completed the following patient safety check: obtained Patient #6’s blood pressure, pulse, and machine safety check at 17:53 PM. 7. The clinical record for Patient #7 was reviewed on 05-23-2024. The treatment records between 04-26-2024 and 05-17-2024 evidenced the following: A. A review of the treatment record dated 05-08-2024 evidenced PCT 18 completed Patient #7’s blood pressure, pulse, and machine safety check at 06:47 AM. PCT 18 then completed the following patient safety check: obtained Patient #7’s blood pressure, pulse, and machine safety check at 07:34 AM. B. A review of the treatment record dated 05-15-2024 evidenced PCT 7 completed Patient #7’s blood pressure, pulse, and machine safety check at 08:11 AM. PCT 17 then completed the following patient safety check: obtained Patient #7’s blood pressure, pulse, and machine safety check at 09:10 AM. PCT 17 then completed the following patient safety check: obtained Patient #7’s blood pressure, pulse, and machine safety check at 10:01 PM. C. A review of the treatment record dated 05-15-2024 evidenced LPN 2 completed Patient #7’s blood pressure, pulse, and machine safety check at 09:02 AM. RN 8 then completed the following patient safety check: obtained Patient #7’s blood pressure, pulse, and machine safety check at 10:04 AM. During an interview on 05-21-2024 at 10:40 AM, RN 1 indicated the Patient Care Technicians (PCTs) cannot run 3 tracks (tracks contain 6 chairs) with 2 PCTs and do it all, with safety checks, taking patients off dialysis treatment, and putting patients on treatment. 8. During an interview on 05-22-2024 at 9:30 AM, the Regional Director of Operations/Interim Regional Vice President, Admin 2, confirmed they noted on the records the patient’s safety checks were being missed.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the Facility Administrator (FA) failed to have a plan for insufficient staffing for 1 of 1 stand alone in-center facilities. Findings Include: 1. During a flash tour of the Water Room on 05-20-2024 at 9:58 AM, the Patient Care Technician (PCT) 3, was observed mixing bicarb. PCT 3 indicated they were the only preceptor left, staff were leaving the facility, management was not giving yearly raises, they worked short staff, and they went home crying a lot of evenings. 2. During a flash tour of the treatment floor on 05-20-2024 at 10:30 AM, Patient #8 indicated the facility had cut their treatment short to 3 hours a couple of weeks ago due to staffing shortages. Patient #8 stated, “They are losing help. These girls are doing their best, but they are tired.” 3. On 05-20-2024 at 9:50 AM, the Facility Administrator (FA) and Director of Operations (DO) introduced themselves. When explained that the survey was for complaints, they indicated they were not surprised due to many changes at the facility in staffing and management. 4. During the Entrance Conference on 05-20-2024 at 10:55 AM, when queried regarding the facility shortening patient’s treatments and any adverse events occurring. The Medical Director confirmed due to staffing shortages and patient safety, the facility shortened treatment times 2 days in 1 week 3, hours of treatment time for those who were treated for 4 and 4 hours for those treated for 5 hours. The Medical Director further indicated they communicated with the nurses and gave orders for shorter treatment times for only those patients without increased Potassium or other treatment needs that could not be shortened. 5. During an interview on 05-20-2024 at 11:24 AM, the Medical Director indicated they were not surprised by the complaints and further confirmed no adverse events or negative outcomes had occurred. The Medical Director indicated due to staffing shortages, the nurses are unable to document vaccines correctly, follow up on patient histories, double check weights, and have had increased patient complaints regarding staffing issues. The Medical Director indicated staff left due to the refusal of salary increases by management, and there had been less appreciation shown by management to the direct care staff. These issues they indicated they have brought up in their Quality meetings and management meetings. 6. During an interview on 05-20-2024 at 12:38 PM, PCT 4 indicated the facility’s management did not care about the staff. 7. During an observation of the treatment floor on 05-20-2024 at 1:10 PM, 35 patients received dialysis treatment, 3 PCTs, and 2 Registered Nurses (RN). 8. During an interview on 05-20-2024 at 1:10 PM, RN 3 indicated there were 35 patients, 3 PCTs, and 1 RN. RN 3 further indicated management is not available. 9. During an interview on 05-20-2024 at 1:25 PM, PCT 1 and PCT 2 indicated due to staffing, they had to run 2 to 3 tracks, which included 12-18 patients who received dialysis treatments. The PCTs further confirmed management had not been out of the floor to monitor staffing issues. 10. During an interview on 05-20-2024 at 1:45 PM, PCT 6 confirmed they started in November and indicated the staffing situation is worse now. PCT 6 indicated during the evening, and they had 30 patients who had received dialysis treatment with 3 PCTs and 1 RN. 11. During an observation on 05-20-2024 from 1:50 PM to 2:15 PM, dialysis machine alarms at Stations #7, 8, and 9 sounded. Patient #20 at Station #9 had a dialysis machine alarm regarding a high systolic blood pressure. Patient #21 at Station #8 had a low systolic blood pressure. Patient #22 at Station #7 had a low systolic blood pressure. PCT 1 answered the alarms after they had completed the initiation of dialysis treatment at Station #32 at 2:15 PM. During an interview on 05-20-2024 at 2:15 PM, PCT 2, entered the treatment area after they completed the water test. PCT 2 stated, “See, we need help,” while they assisted PCT 1 with machine alarms. 12. A review of the Patient Grievance Report dated 12-27-2023 through 05-20-2024 revealed patient grievances related to staff care, attitude, chair location, treatment denial due to the patient’s unstable condition, and missing phone. Requested the staff and patient grievances regarding staffing. During an interview on 05-20-2024 at 3:00 PM, when asked about staff and patient complaints about staffing and shortened treatments, the FA and DO, indicated they did not have those. 13. During an interview on 05-20-2024 at 3:35 PM, Patient #23 confirmed the facility shortened their treatment to 3 hours a couple of weeks ago due to a staffing shortage. 14. During the Daily Conference on 05-20-2024 at 4:15 PM, the FA confirmed they had received complaints from staff and patients and did not complete grievance reports. 15. During an interview on 05-21-2024 at 9:30 AM, Patient #3 confirmed they had filed a grievance regarding care and staffing. Patient #3 indicated they had no further problems with care and stated, “They do their best, but they need help.” 16. During an observation on 05-21-2024 at 10:45 AM, 32 patients were connected to dialysis machines, 2 RNs, and 6 PCTs on the treatment floor. PCT 7 was observed to ask for help from RN 2, who was on the phone. PCT 7 indicated 2 PCTs cannot do 3 tracks. PCT 7 stated loudly, “I have never been at a place this bad.” During an interview on 05-21-2024 at 10:45 AM, when questioned regarding the staffing on the treatment floor, the FA in their office stated,” What is all the noise?” Further, after the FA was led to the treatment floor to observe alarms and PCT 7, they indicated they did not know how they missed staffing a PCT. 17. During an interview on 05-20-2024 at 10:56 AM, Patient #1 confirmed their treatments always ran late. Patient #1 indicated their start time was 10:00 AM, and they were put on for treatment at 10:27 AM. 18. During an observation on the treatment floor on 05-20-2024 at 10:57 AM, Patient #12 at Station #29 indicated they had waited an hour before treatment and asked the surveyor if this was the surveyor’s fault. RN #2 indicated Patient #1 never complained. Their scheduled time to go on was 9:50 AM, and they started treatment today at 10:23 AM. Patient #1 further indicated they had plans today, and their time matters. FA was obtained for Patient #1 to voice concerns too. 19. A review of a facility document titled, “Meeting Minutes” dated April 20, 2024, indicated a review of the patient experience was at 51% goal of 75% with a new schedule rolling out on 6-10-2024 to create efficiency and assist staff with patients getting on time. 20. A review of a Fresenius Medical Care job description titled, “Facility Administrator” version date 08-11-2024, indicated but was not limited to, “... Manages and oversees the daily operations of the facility ... Manages the day to day activities and workload of the facility staff providing guidance and leadership as appropriate to ensure the effective, efficient and timely execution of duties and tasks ... Addresses the patient concerns, issues, and questions ... Creates, maintains, and communicates efficient and timely employee schedules according to staffing needs of the facility to ensure adequate staffing on a daily basis ... “ 21. During an interview on 05-21-2024 at 11:15 AM, Patient #10 was in the front lobby and stated, “This place sucks.” Patient #10 indicated treatment times are always late and they had been waiting for 30 minutes. 22. During an interview on 05-21-2024 at 11:45 AM, RN 2 indicated they were mentally drained, and the facility’s staffing shortage had taken a toll on them. 23. During an interview on 05-21-2024 at 12:30 PM, PCT 10 indicated they were becoming increasingly frustrated with taking off 12 patients, no incentives, no salary increases, and now having health concerns with chest pain. 24. During an interview on 05-21-2024 at 3:15 PM, the Regional Director of Operations/Interim Vice President, Corp 2, confirmed the facility’s scheduling was completed incorrectly. Corp 2 further indicated the treatment times of the patients on and off were too many at the same time for the PCT in that track. 25. During a daily conference on 05-21-2024 at 4:20 PM, the FA indicated they entered Patient #12’s complaint today and further confirmed there were staffing issues today. 26. During an interview on 05-22-2024 at 5:15 PM, Patient #5 confirmed their treatments were shorted to 3 hours a couple of weeks ago. Patient #5 said it was horrible for the staff to take everyone off at the same time due to a staffing shortage. Patient #5 voiced their concern if other good staff left as well. When asked if they complained to the management staff, Patient #5 indicated the manager was not available for calls, return calls, or out on the treatment floor. 27. During an interview on 05-23-2024 at 9:30 AM, the Medical Social Worker (MSW) indicated the patients had voiced concerns regarding staffing. The MSW further indicated management rotates at the dialysis center, there were communication gaps, nurses pulled to be PCTs, and the direct care staff were tired. 28. During an interview on 05-23-2024 at 12:00 PM, Physician 1, a facility Nephrologist (a kidney doctor), confirmed they were made aware of the facility’s staffing issue and agreed with the Medical director’s decision to shorten treatments for safety. Physician 1 further indicated their patients had no adverse outcomes.”