Fresenius Medical Care at Benton Harbor

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 38304 Based on record review and interview, the Facility failed to update and revise the Plan of Care; failed to monitor and report severe hypertension per policy; failed to ensure patient treatments were delivered as prescribed; and failed to ensure the registered nurse reported an acute finding with a Central Venous Catheter, resulting in the potential for unmet needs and less than optimal patient outcomes for all 85 patients served by the facility. See specific tags: V-542 - Failure to update/revise the Plan of Care. V-543 - Failure to ensure staff reported, assessed, and addressed high blood pressures. V-544 - Failure to ensure hemodialysis treatments were delivered as prescribed. V-551 - Failure to ensure the registered nurse reported an acute finding with a Central Venous Catheter.”

“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: 47976 Based on observation, record review, and interview, the facility failed to ensure the emergency supplies on the emergency cart were not expired per facility policy, resulting in the potential to affect the health and safety of all 85 patients receiving dialysis from this facility in the event of an emergency. Findings include: **Policy titled “Emergency Medications, Equipment and Supplies” (published 2/3/25) stated the emergency cart must be, “Checked monthly or after use for contents, expiration dates, cleanliness, and proper functioning of all equipment.” During dialysis floor observation on 4/29/25 at 1052, the contents of the emergency crash cart were reviewed. During review, the following supplies were found to be expired: 13 - 10 mL syringes with Luer-lock (expired 3/31/23) 1 - 3 mL syringe with Luer-lock (expired 7/31/23) 3 - Safety AV Fistula Needle Sets (expired 10/1/23 x2, 11/1/22 x1) 3 - Masterguard Fistula Needle Sets (expired 9/30/24, 3/31/24, 2/28/25) 2 - 0.9% 1000 mL Sodium Chloride bags (expired 9/2024, 8/2024) 1 - Volumat Line (Primary Infusion Set) (expired 10/13/24) Findings were reviewed with and acknowledged by the registered nurse on the floor (Staff G) upon discovery. Findings were again reviewed with and acknowledged by the Facility Administrator (Staff A) and Clinical Manager (Staff D) during an interview on 4/30/25 at 1102.”

“Names and Contact Information CFR(s): §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.542(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients’ physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO’s Donation Service Area (DSA). This Standard is not met as evidenced by: 38304 Based on observation, record review and interview, the Facility failed to maintain an updated patient census and patient emergency contacts in the emergency preparedness program, resulting in the potential for inadequate Facility response during an emergency event, and potentially endangering the safety of all 85 in-center patients receiving treatment in the Facility during an emergency event. Findings include: During dialysis floor observation on 4/29/25 at 1118, the contents of the emergency “to go” container located adjacent to the emergency crash cart was inspected. The patient contact information used to ensure that all patients would be accounted for during an evacuation emergency was reviewed and noted the last update occurred on “November 2024”. A list of patients admitted within the last 90 days of 4/29/25 was compared against the emergency patient contact list. All 13 newly admitted (less than 90 days) patient names were not included in the emergency patient contact list. This finding was reviewed and acknowledged by the Facility administrator (Staff A) later that day at 1250. Staff A further acknowledged the emergency contact list was not updated monthly as it should have been. The Facility failed to ensure an up to date and accurate patient list was available for use in the event of an emergency to account for the safety of all patients involved.”

“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: 47976 Based on observation, record review, and interview, the facility failed to ensure staff performed hand hygiene per facility policy, resulting in the potential for the spread of infectious agents to all 85 patients receiving dialysis at this facility. Findings include: **Policy titled “Hand Hygiene” (published 11/6/23) stated, “Hands will be ...Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water ...Immediately after removing gloves ...”. During dialysis floor observation on 4/29/25 at 1126, patient care technician (Staff H) was observed removing her gloves near the computer station across from station #11 and putting on clean gloves without performing hand hygiene first. During dialysis floor observation on 4/29/25 at 1450, registered nurse (Staff G) was observed wearing gloves at station #10 while giving the patient a form to sign on a clipboard. After getting the pen and clipboard back from the patient, Staff G was observed removing her gloves and using the pen to write on the clipboard without performing hand hygiene first. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and Clinical Manager (Staff D) during an interview on 4/30/25 at 1102.”

“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: 47976 Based on observation, record review, and interview, the facility failed to ensure items taken into the dialysis station were cleaned and disinfected before being taken into a common clean area, resulting in the potential for the spread of infectious agents to all 85 patients receiving dialysis at this facility. Findings include: **Policy titled “Cleaning and Disinfecting the Dialysis Station” (revised 9/5/23) stated “After use, any non-disposable equipment and supplies brought into the dialysis station (ex. Stethoscope) must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station.” During dialysis floor observation on 4/29/25 at 1102, patient care technician (Staff H) was observed cleaning station #10. After the cleaning process, Staff H used her gloved (dirty) hands to remove the stethoscope from around her neck and placed it on the clean counter without disinfecting it first. During dialysis floor observation on 4/29/25 at 1412, a registered nurse (Staff G) was observed using the Hoyer lift (a machine used to lift patients who cannot stand) with the patient at station #13. After completing the transfer, Staff G was observed rolling the Hoyer lift back to its storage location without disinfecting it first. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and Clinical Manager (Staff D) during an interview on 4/30/25 at 1102.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 46476 Based on observation, interview, and record review, the facility failed to ensure staff providing central venous catheter (CVC) care adhered to infection control procedures per facility policy during 1 (Station #6) of 4 CVC care observations, resulting in the risk for a blood stream infection for that patient. Findings include: On 4/30/25 at 1045 during hemodialysis treatment floor observation, Staff J, a Certified Clinical Hemodialysis Technician (CCHT), was observed while preparing the patient at Station #6 for initiation of hemodialysis. Staff J was observed removing one of two caps from the end of the CVC and scrubbed the end (hub) with an alcohol pad for 5 seconds before attaching a sterile syringe. Staff J was observed removing the second of two caps from the end of the CVC and scrubbed the hub with an alcohol pad for 6 seconds before attaching a sterile syringe. Due to patient needs, Staff J was not able to be interviewed at the time of the observation. Facility policy titled “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dializer”; Reference Number: 45651, was reviewed on 5/1/25. On page 4., it stated “Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad ... for 10-15 seconds and any time caps are removed, or bloodlines are disconnected ... to reduce risk of contamination.” The above findings were reviewed with the Facility Administrator (Staff A) and the Clinical Manager (Staff D) during interview on 5/1/25 at 1215. Staff D acknowledge that Staff J should have scrubbed both hub ends of the CVC for 10-15 seconds each.”

“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: 47976 Based on observation, record review, and interview, the facility failed to ensure patient access sites were in view of staff during dialysis treatment at 1 (station #14) of 20 stations, resulting in the potential for needle dislodgement or line disconnection to go undetected and for significant bleeding to occur. Finding include: **Policy titled “Patient Assessment and Monitoring” (published 5/1/23) stated during treatment, “Ensure access remains uncovered throughout the treatment,” and “Document any findings or interventions in the medical record.” During dialysis floor observation on 4/29/25 at 1330, it was noted the access site for the patient at station #14 was completely covered by a blanket. Between 1330 and 1400, multiple staff members were seen walking past station #14 without uncovering her access site. Patient care technician (Staff I) was also seen disinfecting station #13 (next to the patient) at 1410. At 1415, registered nurse (Staff G) was standing at the nurse’s station across from station #14 and was asked if she could see the access site for the patient at station #14. Staff G stated she could not, but stated the patient always covers herself up due to being cold. Staff G was asked if this was documented on the daily treatment sheet. Staff G stated “it should be”, but was unsure if it was actually done by staff. During review of the treatment sheet from 4/29/25, it was noted Staff I documented “Access visible” at 1306 and 1340 (around the time of the observation). There were no other checks documented prior to treatment ending at 1430. There was no documentation regarding the patient being asked to uncover her access site. Additionally, during an interview with the Medical Director (Staff C) on 4/30/25 at 1330, Staff C was asked about her expectation regarding patients who continue to cover themselves up during dialysis treatment. Staff C stated it should be documented on the daily treatment sheet and there should be documentation regarding efforts to educate the patient about the dangers of covering their access site. There was no documentation regarding education provided to the patient regarding her access site. Findings were again reviewed with and acknowledged by the Facility Administrator (Staff A) and Clinical Manager (Staff D) during an interview on 4/30/25 at 1102.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 46476 Based on record review and interview, the facility failed to provide medication as outlined in the patients plan of care in 1 (P-3) of 7 records reviewed, resulting in a medication not being administered as ordered by the physician and potentially leading to a poor patient outcome. Findings include: P-3: This 59-year-old was admitted to the facility on 7/18/24 with diagnoses including end stage kidney disease and type 2 Diabetes. The medical record was reviewed on 4/30/25 and included 7 hemodialysis treatment sheets dated between 4/15/25 and 4/29/25. Active physician orders (start date 2/20/25) included a hemodialysis treatment time of 4 hours, and Heparin (medication used to prevent blood from clotting), to be administered throughout each treatment at a dose of 1500 Units per hour (total Heparin dose of 6000 Units in 4 hours). The following Heparin doses were noted during review of the hemodialysis treatment sheets: On 4/17/25, the total dialysis treatment time was 3 hours and 43 minutes (total Heparin dose should be 5575 Units). Staff N, a registered nurse (RN), documented a total administration of 1500 Units given during the treatment (4075 Units less than prescribed). On 4/19/25, an RN, Staff P, documented “No” under the Heparin Infusion section indicating that the 1500 Unit/hour dose was not given as prescribed during the treatment. Staff P did not document why the Heparin was not given as prescribed and did not document whether the physician was notified. On 4/22/25, the total dialysis treatment time was 3 hours and 44 minutes (total Heparin dose should be 5600 Units). The Certified Clinical Hemodialysis Technician (CCHT), Staff J, documented a total administration of 3000 Units given during the treatment (2600 Units less than prescribed). The above findings were reviewed and acknowledged by the Facility Administrator (Staff A) and the Clinical Manager (Staff D) during interview on 5/1/25 at 1215.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 38304 Based on record review and interview, the Facility failed to update/revise the Plan of Care (POC) that met the needs of the patient in 1 (P-1) of 3 records reviewed with unstable intra-dialytic hypertension, from a total sample of 7 records reviewed, resulting in the potential for unmet needs and poor clinical outcomes. Findings include: P-1: This 35-year-old patient was admitted to the dialysis Facility on 10/17/24, with the diagnosis of Type-1 diabetes mellitus with diabetic chronic kidney disease, and hypertension. On 4/30/25, review of P-1’s POC (1 of 3 reviewed) dated 11/5/24, documented under “BP (blood pressure) and Fluid Management” the following goal due 1/1/25: “Achieve BP Control as specified by the patient’s physician.” A total of 9 interventions were noted to help control BP which ranged 188/106 to 225/114 from 10/22/24 through 11/2/24 during dialysis treatments. No medications were ordered or administered to help lower P-1’s BP during dialysis treatments times noted above. Under “Transplantation Status” the Social Worker/Staff E documented, “Patient is interested in pursuing a transplant once he is more medically stable.” Review of P-1’s following POC (2 of 3 reviewed) dated 1/7/24, revealed unstable status due to “Concurrent poor nutrition status, unmanaged anemia and inadequate dialysis.” Under “Transplantation Status”, documentation by Staff E noted “Patient is interested in a transplant but is still too medically unstable to be referred at this time.” Concerning P-1’s BP, this POC had documented the exact same goal (due 2/28/25) and 9 interventions word for word as the POC dated 11/5/25 despite BP still significantly high ranging 168/105 to 204/129 from 12/19/24 through 1/4/25 during dialysis treatments. No medications were ordered or administered to help lower P-1’s BP during dialysis treatments times noted above. The POC (3 of 3 reviewed) dated 2/4/25, had made P-1 a stable status despite Staff E’s following documentation, with the next scheduled POC on 2/4/26. Under “Transplantation Status” Staff E documented “Patient is still medically unstable.” Concerning P-1’s BP control, this POC had documented the exact same goal (due 3/1/25) and 9 interventions as the two previous POC’s above word for word. BP readings ranged 161/93 to 206/117 from 1/16/25 through 2/1/25 during dialysis treatments. No medications were ordered or administered to help lower P-1’s BP during dialysis treatments times noted above. An additional review of P-1’s six most recent treatment flow sheets revealed the following and continued concerns with uncontrolled hypertension experienced during dialysis treatments. On 4/29/25 at: 1211: (start of treatment), BP (blood pressure) was recorded by patient care technician (PCT/Staff K) as 172/107 with no RN notification. 1244: BP documented as 186/107 by Staff K with no RN notification. 1336: BP documented as 169/136 by PCT/Staff I with no RN notification. 1403: BP documented as 201/120 by Staff K with no RN notification. 1436: BP documented as 191/123 by Staff K with no RN notification. 1502: BP documented as 213/134 by Staff K with no RN notification. 1538: BP documented as 221/140 by Staff K with no RN notification. 1611: BP documented as 210/129 by Staff K with no RN notification. 1613: (post-dialysis treatment) BP documented as 210/129 by RN/Staff G. At 1711, Staff G documented under “Nursing Evaluation” that “No unusual findings noted.” No physician notification and no blood pressure medications were available (none ordered) to be administered to P-1. On 4/26/25 at: 1206: (start of treatment), BP was recorded by patient care technician (PCT/Staff K) as 158/101 with no RN notification. From 1206 through 1334, BP recordings ranged 161-178/104-107 with no RN notification. BP recordings did increase further as follows: 1402: BP documented as 185/115 by PCT/Staff L with no RN notification. 1434: BP documented as 180/101 by Staff L with no RN notification. 1502: BP documented as 191/102 by Staff K with no RN notification. 1436: BP documented as 191/123 by Staff K with no RN notification. 1502: BP documented as 191/102 by RN/Staff N. 1532: BP documented as 201/111 by Staff L with no RN notification. 1630: BP (28 minutes late per Facility policy) documented as 204/123 by Staff L with no RN notification. 1637: (post-dialysis treatment) BP documented as 204/128 by Staff L. Staff N under “Nursing Evaluation” at 1718 had no documentation concerning P-2’s sustained elevated blood pressure. No physician notification and no blood pressure medications were available (none ordered) to be administered to P-1. Staff N documented hypertensive issues and instructed P-1 to take home BP meds as soon as possible. All three POC goals above for BP had expired with no improvement overall. No new interventions were added or adjusted to help P-1 become more medically stable and have a better chance of having the desired kidney transplant. In addition, all 9 interventions on each POC were listed as “In Progress” and dated as 11/16/2023 (prior to admission) by the same RN/Staff R. No documented plans for the dialysis IDT (inter-disciplinary team) were made to review P-1’s BP status until 2/4/26. These findings above were reviewed and acknowledged by the Facility Administrator (Staff A) and Clinic Manager (Staff D) during an interview on 5/1/25 at 1418. Staff A and D were then queried if the above findings met Facility expectations and if more should have been done to help manage P-1’s uncontrolled BP’s. Both noted expectations were not met and more should have been done to better control high BP readings experienced during dialysis. The Facility failed to follow its policy referenced below and failed to meet P-1’s clinical needs. Facility Policy: “Comprehensive Interdisciplinary Assessment and Plan of Care” (dated 7/3/2023) Version 6 stated under “Failure to Achieve Plan of Care Outcome” the following: “If the patient specific expected outcome as determined by the attending physician, IDT and patient for the Plan of Care is not achieved within the identified timeframe: The Interdisciplinary team must adjust the patient’s Plan of Care and document changes made to the POC. Implement the Plan of Care changes to address the identified issues.””

“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: 46476 Based on record review and interview, the facility failed to ensure staff reported, assessed, and addressed high blood pressures in 3 (P-1, 5, and 7) of 7 records reviewed, resulting in the potential for unrecognized changes in volume status and poor patient outcomes. Findings include: Facility policy titled “Patient Assessment and Monitoring”; Published: 05/01/2023, was reviewed on 12/3/24. On page 1., under “Data Collection”, it stated “ ... If the PCT/LPN note any changes or abnormal findings ... the registered nurse must assess the patient ... The Registered Nurse will assess/re-assess any findings pre or during treatment as needed.” 38304 P-1: This 35-year-old patient was admitted to this dialysis Facility on 10/17/24, with the diagnosis of Type-1 diabetes mellitus with diabetic chronic kidney disease, hypertension. During record review on 4/30/25, review of P-1’s six most recent treatment flow sheets revealed the following concerns with uncontrolled hypertension. On 4/29/25 at: 1211: (start of treatment), BP (blood pressure) was recorded by patient care technician (PCT/Staff K) as 172/107 with no RN notification. 1244: BP documented as 186/107 by Staff K with no RN notification. 1336: BP documented as 169/136 by PCT/Staff I with no RN notification. 1403: BP documented as 201/120 by Staff K with no RN notification. 1436: BP documented as 191/123 by Staff K with no RN notification. 1502: BP documented as 213/134 by Staff K with no RN notification. 1538: BP documented as 221/140 by Staff K with no RN notification. 1611: BP documented as 210/129 by Staff K with no RN notification. 1613: (post-dialysis treatment) BP documented as 210/129 by RN/Staff G. At 1711, Staff G documented under “Nursing Evaluation” that “No unusual findings noted.” No physician notification and no blood pressure medications were available (none ordered) to be administered to P-1. On 4/26/25 at: 1206: (start of treatment), BP was recorded by patient care technician (PCT/Staff K) as 158/101 with no RN notification. From 1206 through 1334, BP recordings ranged 161-178/104-107 with no RN notification. BP recordings did increase further as follows: 1402: BP documented as 185/115 by PCT/Staff L with no RN notification. 1434: BP documented as 180/101 by Staff L with no RN notification. 1502: BP documented as 191/102 by Staff K with no RN notification. 1436: BP documented as 191/123 by Staff K with no RN notification. 1502: BP documented as 191/102 by RN/Staff N. 1532: BP documented as 201/111 by Staff L with no RN notification. 1630: BP (28 minutes late per Facility policy) documented as 204/123 by Staff L with no RN notification. 1637: (post-dialysis treatment) BP documented as 204/128 by Staff L. Staff N under “Nursing Evaluation” at 1718 had no documentation concerning P-2’s sustained elevated blood pressure. No physician notification and no blood pressure medications were available (none ordered) to be administered to P-1. Staff N documented hypertensive issues and instructed P-1 to take home BP meds as soon as possible. The findings above were reviewed and acknowledged by the Facility Administrator (Staff A) and Clinic Manager (Staff D) during an interview on 5/1/25 at 1412. Staff D was noted that all technicians should report to the RN any elevated blood pressures according to Facility policy (referenced in above citation). 47976 **Policy titled “Patient Assessment and Monitoring” (published 5/1/23) stated during treatment, the following blood pressures should be reported to the nurse 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. 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.” P-5: This 52-year-old patient was admitted to this dialysis facility on 5/14/20 with the diagnosis of end stage renal disease. During record review on 4/30/25, it was noted the following blood pressure readings were recorded by a patient care technician (PCT): On 2/2/23 222/120 at 1104 179/110 at 1133 183/100 at 1202 196/100 at 1304 On 1/31/23 184/99 at 1125 On 1/28/23 187/88 at 1021 188/97 at 1032 188/109 at 1102 207/109 at 1132 On 1/24/23 243/114 at 1122 Post treatment nursing notes on the daily treatment sheets stated there was intermittent hypertension throughout treatment and that this was “normal” for the patient, however, there was no documentation the PCT notified the registered nurse of the elevated blood pressures during treatment to determine if any intervention was necessary. P-7: This 32-year-old patient was admitted to this dialysis facility on 2/23/24 with the diagnosis of end stage renal disease. During record review on 5/1/25, it was noted the following blood pressure readings were recorded by a patient care technician (PCT): On 4/28/25 215/131 at 1500 209/132 at 1534 193/128 at 1630 193/128 at 1633 184/110 at 1703 181/127 at 1734 184/119 at 1803 185/114 at 1835 181/104 at 1902 On 4/25/25 195/124 at 1452 182/115 at 1506 165/123 at 1802 162/111 at 1838 187/111 at 1851 On 4/23/25 197/133 at 1519 175/120 at 1606 173/108 at 1700 173/108 at 1704 186/102 at 1730 186/102 at 1731 162/101 at 1803 188/112 at 1830 188/112 at 1835 On 4/21/25 179/107 at 1515 173/112 at 1537 172/101 at 1705 188/95 at 1750 On 4/18/25 187/118 at 1125 188/107 at 1201 196/116 at 1235 195/108 at 1301 Several post treatment nursing notes on the daily treatment sheets stated there was intermittent asymptomatic hypertension throughout treatment and that this was “normal” for the patient, however, there was no documentation the PCT notified the registered nurse of the elevated blood pressures during treatment to determine if any intervention was necessary. During an interview with the Facility Administrator (Staff A) and Clinic Manager (Staff D) on 5/1/25 at 1102, Staff D was asked about the expectation for the PCT to report elevated blood pressures to the nurse during treatment. Staff D stated blood pressures during treatment should be reported per the policy above. Staff D also acknowledged that although the elevated pressures were noted as “normal” for P-5 and P-7 after treatment, elevated pressures should be reported to the nurse by the PCT during treatment so the nurse can decide whether any intervention is needed. Staff A and Staff D acknowledged the findings at the time of interview.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 46476 Based on record review and interview, the facility failed to ensure hemodialysis treatments were delivered as prescribed for 3 (P-3, 4, and 7) of 7 records reviewed; and failed to ensure machine parameters for blood flow rate (BFR) and dialysate flow rate (DFR) were documented per facility policy in 1 (P-4) of 7 records reviewed resulting in the potential to impact the adequacy of the dialysis for these patients and poor patient outcomes. Findings include: P-3: This 59-year-old was admitted to facility on 7/18/24 with diagnoses including end stage kidney disease and type 2 Diabetes. The medical record was reviewed on 4/30/25 and included 7 hemodialysis treatment sheets dated between 4/15/25 and 4/29/25. Active physician orders for hemodialysis included the BFR to be 400 milliliters per minute (mL/min) during each treatment. On the treatment sheet dated 4/26/25, the treatment started at 1148. At 1207 the BFR was recorded as 450 mL/min (50 mL/min above prescribed rate). The BFR was not recorded again until 1234 (27 minutes later) when it was decreased to 300 mL/min (100 mL/min below prescribed rate) and remained at that rate until the treatment ended at 1447 (2 hours and 59 minutes total). There was no documentation noting why the BFR had been adjusted either above or below the prescribed rate during this treatment. There was no documentation that the physician was notified of changes to the BFR. P-4: This 77-year-old was admitted to facility on 4/7/25 with diagnoses including end stage kidney disease and type 2 Diabetes. The medical record was reviewed on 5/1/25 and included 6 hemodialysis treatment sheets dated between 4/16/25 through 4/28/25. Active physician orders included a total dialysis treatment time of 3 hours and 30 minutes; the BFR to be 250 mL/min each treatment; and the DFR to be 500 mL/min during each treatment. The following were noted during review: On 4/16/25, the BFR was 350 mL/min for the total duration of the treatment (3 hours and 26 minutes). There was no documentation noting why the BFR was 100 mL/min greater than prescribed. On 4/18/25, the BFR was 300 mL/min for the duration of the treatment (3 hours and 10 minutes). There was no documentation noting why the BFR was 50 mL/min greater than prescribed. On 4/21/25, the BFR was 350 mL/min for the duration of the treatment (3 hours and 33 minutes). There was no documentation noting why the BFR was 100 mL/min greater than prescribed. On 4/25/25, the total treatment duration was 3 hours and 27 minutes. The treatment started at 1457. There was no documentation of what the BFR or DFR were running at until 1803 (3 hours and 6 minutes after the treatment started). There was no documentation of physician notification for changes to BFR on any of the above treatment sheets. On 4/30/25 at 1400, an interview was conducted with the Medical Director of the facility (Staff C). Staff C was asked what the expectation was for changes made to a dialysis prescription during a hemodialysis treatment. Staff C stated that if an adjustment in the hemodialysis prescription was needed, staff should document the reason for the change on the treatment sheet and inform the physician of the issue by the end of that day. Facility policy titled “Patient Assessment and Monitoring”; Reference Number: 45284, was reviewed on 5/1/25. On page 1., it stated “The RN will notify the patient’s physician/physician extender of any abnormal findings, if necessary ... On page 4., it stated “During Treatment ... Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes ...” On page 6., it stated “3. Machine Parameters ... Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow ... Check dialysate flow rate setting is correct, and the prescribed flow is being delivered ... Document the findings in the medical record.” The above findings were reviewed and acknowledged by the Facility Administrator (Staff A) and the Clinical Manager (Staff D) during interview on 5/1/25 at 1215. 47976 P-7: This 32-year-old patient was admitted to this dialysis facility on 2/23/24 with the diagnosis of end stage renal disease. During record review on 5/1/25, it was noted the dialysis prescription (dated 4/18/25) ordered the blood flow rate (BFR) at 400 milliliters per minute (mL/min) and the dialysate flow rate (DFR) at 800 mL/min. Upon review of the last 6 treatment sheets, it was noted the DFR was run incorrectly as follows: On 4/21/25, the DFR was run at 500 mL/min for the entire treatment (2 hours and 27 minutes) On 4/18/25, the DFR was run at 500 mL/min for the entire treatment (4 hours and 6 minutes) There was no documentation regarding the reason the DFR was not run at the prescribed rate. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) and Clinical Manager (Staff D) during an interview on 4/30/25 at 1102.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 46476 Based on observation, interview, and record review, the facility failed to ensure the registered nurse reported an acute finding with a Central Venous Catheter (CVC) during dialysis in 1 (P-3) of 1 observation for which a prescription was modified in response to the presence of increased pressure during the treatment. This practice has the potential of resulting in the patient’s access site failure and poor patient outcomes. Findings include: On 4/29/25 during treatment floor observations at 1415, comparison was made between the physician order in the medical record and the prescription which was set on the dialysis machine and currently running for the patient at station #10. It was noted that the patient at station #10 was P-3. Upon prescription comparison, it was noted that the physician order in the medical record for P-3’s blood flow rate (BFR) was 400 milliliters per minute (mL/min) each treatment. The machine providing dialysis for P-3 at the time of the observation showed the BFR running at 200 mL/min (200 mL/min less than prescribed in the medical record). At 1420, an interview was conducted with Staff G, the registered nurse (RN) in charge of the care for P-3 at the time of the observation. Staff G was asked why the BFR for P-3 at station #10 was set at 200 mL/min instead of the prescribed rate of 400 mL/min. Staff G stated that the access site (CVC) was “pulling hard” and the arterial pressure was high, so she needed to turn the BFR down from 400 to 200 mL/min. Staff G was asked what “pulling hard” meant for the access site and if running the BFR at 200 mL/min would affect the adequacy of the dialysis. Staff G stated that decreasing the BFR would decrease the adequacy, and it was possible that the access site was beginning to clot. Staff G was asked if the decreased BFR and the possibility of access site clotting for P-3 would be reported to the physician for follow-up. Staff G stated “yes”, and she would report this to the physician in an email at the end of the day. Staff G also stated that the patient may need an intervention medication pushed through the catheter, or a referral to see the vascular doctor. On 4/30/25 at 1400, an interview was conducted with the Medical Director of the facility (Staff C). Staff C was asked what the expectation was for changes made to a dialysis prescription during a hemodialysis treatment. Staff C stated that if an adjustment in the hemodialysis prescription was needed, staff should document the reason for the change on the treatment sheet and inform the physician of the issue by the end of that day. Staff C stated she receives an email at the end of each day from the facility staff which listed all the issues encountered that day. Staff C also stated if there was a concern with the vascular access site, intervention would be needed in a timely manner. On 5/1/25, the end of day email to the physician (referred to above) from 4/29/25 was reviewed. There was no information regarding P-3 on the end of day email sent to Staff C on 4/29/25. The facility failed to inform the physician of an acute change in P-3’s vascular access. The above findings were reviewed and acknowledged by the Facility Administrator (Staff A) and the Clinical Manager (Staff D) during interview on 5/1/25 at 1215.”

“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: 47976 Based on record review and interview, the facility failed to ensure medical records were complete and accurate in 4 (P-1, 5, 6, 7) of 7 records reviewed, resulting in the potential for treatment errors and poor patient outcomes. Findings include: P-5: This 52-year-old patient was admitted to this dialysis facility on 5/14/20 with the diagnosis of end stage renal disease. During record review on 4/30/25, it was noted the last 6 treatment notes (dated 1/21/23, 1/24/23, 1/26/23, 1/28/23, 131/23, and 2/2/23) all stated the patient had “Vomiting or Diarrhea” in the daily nursing assessment. There was no documentation to indicate further assessment or which symptom the patient was having. During an interview on 5/1/25 at 1102, the Clinic Manager (Staff D) was asked about the documentation above. Staff D stated it was a flaw of the documentation system because it only allowed those 2 options together. Staff D agreed they should be separated to provide a better understanding of the patient’s status. Staff D also agreed it was unclear on what symptoms this patient was having based on the documentation and acknowledged the findings. The Facility Administrator (Staff A) was also present during the interview and acknowledged the findings. P-6: This 40-year-old patient was admitted to this dialysis facility on 1/6/22 with the diagnosis of systemic lupus erythematosus (an illness that attacks the immune system and can lead to kidney failure). During record review on 4/30/25, the following was noted: On 4/26/25, it was documented “Declined [Patient refusal]” next to a recommendation to “Increase today’s treatment duration by 15 minutes and utilize sequential or pure UF of the first 15 minutes of treatment.” [sic] It was also documented “Declined [Patient refusal]” next to a recommendation to “ ...adjust Target Weight Removal to Max Hourly UFR, not to exceed UFR of 13 mL/kg/hr.” [sic] On 4/3/25, 4/5/25, and 4/10/25, it was documented “Declined [Patient refusal]” next to a recommendation to “Adjust Target Weight Removal to 0.5 kg below EDW not to exceed UFR of 13 ml/kg/hr.” [sic] P-7: This 32-year-old patient was admitted to this dialysis facility on 2/23/24 with the diagnosis of end stage renal disease. During record review on 5/1/24, the following was noted: On 4/21/25, 4/23/25, 4/25/25, and 4/28/25, it was documented “Declined [Patient refusal]” next to a recommendation to “Increase today’s treatment duration by 15 minutes and utilize sequential or pure UF of the first 15 minutes of treatment.” [sic] It was also documented “Declined [Patient refusal]” next to a recommendation to “ ...adjust Target Weight Removal to Max Hourly UFR, not to exceed UFR of 13 mL/kg/hr.” [sic] On 4/18/25, it was documented “Declined [Patient refusal]” next to a recommendation to “Adjust Target Weight Removal to 0.2 kg below EDW not to exceed UFR of 13 mL/kg/hr.” [sic] During an interview on 5/1/25 at 1102, Clinic Manager (Staff D) was asked for documentation of education given to P-6 regarding the risk of refused treatment. Staff D stated although it was marked as a patient refusal, that often wasn’t the case. However,”Patient refusal” was the best/closest option offered by the documentation system. Staff D stated the system used an algorithm to recommend treatments based on data entered prior treatment. Staff D stated these were not always appropriate for the patient because the machine doesn’t consider other complications, like current medical status. Staff D agreed the documentation does not show a clear picture of the patient’s treatment and acknowledged the findings. The Facility Administrator (Staff A) was also present during the interview and acknowledged the findings. Upon further review of the record for P-7, it was noted the dialysis prescription ordered an 8000 unit bolus (a single dose of medication given at once) of heparin (a medication used to prevent blood clotting during dialysis) to be given every treatment starting 12/6/24. Upon review of the last 6 treatment sheets, the following was noted: On 4/28/25, it was documented the 8000 unit bolus of heparin was given at 1534 by Staff K (patient care technician). Upon further review of the treatment sheet, it was noted Staff G (registered nurse) documented, “Heparin Bolus held at start of treatment” at 1516. On 4/23/25, it was documented the 8000 unit bolus of heparin was given at 1514 by Staff L (patient care technician). Upon further review of the treatment sheet, it was noted Staff G documented, “Heparin bolus held” at 1537. During an interview with the Clinic Manager (Staff D) on 5/1/25 at 1102, Staff D was asked if this patient was given the heparin bolus on 4/28/25 and 4/23/25 based on the documentation. Staff D stated that due to the documentation system, the patient care technician (PCT) must select “yes” if there is a chance the bolus may be given later in the treatment - otherwise it cannot be modified. Staff D also stated the bolus was often held for this patient at the beginning of treatment due to blood pressure issues, however, it was sometimes given later in the treatment if possible at either a partial or full dose. When Staff D was asked about the documentation above, Staff D agreed it was not clear whether the patient was given the bolus on either of those days. Staff D stated the nurse should document the details of time and dose delivered in the comments section and acknowledged the findings. Staff A also acknowledged the findings. 38304 P-1: This 35-year-old patient was admitted to this dialysis Facility on 10/17/24, with the diagnosis of Type-1 diabetes mellitus with diabetic chronic kidney disease, hypertension. During record review on 4/30/25, review of P-1’s six most recent treatment flow sheets revealed the following concerns with incomplete documentation regarding the administration of oxygen which was ordered PRN/as needed at 2 liters per nasal canula, during dialysis treatments on the following days: 4/29/25: The RN/Staff G documented under “Ancillary Services” that oxygen (O2) was administered at noon (dialysis treatment started at 1209 and ended at 1612). No explanation was found in the clinical record indicating a change in P-2’s breathing status that warranted O2 administration prior to the initiation of dialysis. PCT (patient care technician/Staff K) documented under “Pre-Dialysis Vitals and Evaluation” at 1207 that there were “no new findings.” Further, oxygen levels prior to or after the implementation of O2 therapy were not evidenced in the medical record. 4/26/25: The RN/Staff N documented under “Ancillary Services” that O2 was administered at 1718 (dialysis treatment started at 1206 and ended at 1636). No explanation was found in the clinical record indicating what changes in P-2’s breathing that warranted O2 administration well after the dialysis treatment had ended. Further, oxygen levels prior to or after the implementation of O2 therapy were not evidenced in the medical record. 4/17/25: PCT (patient care technician/Staff O documented under “Ancillary Services” that O2 was administered at noon (dialysis treatment started at 1202 and ended at 1604). No explanation was found in the clinical record indicating what changes in P-2’s breathing status that warranted O2 administration. Further, oxygen levels prior to or after the implementation of O2 therapy were not evidenced in the medical record. The “Post-Dialysis Vitals and Evaluation” documented by RN/Staff N at 1609 had no explanation/documentation concerning why Staff O administered oxygen to P-2 at noon. The findings above were reviewed and acknowledged by the Clinical Manager (Staff D) during an interview on 5/1/25 at 1415. Staff D was noted that Facility expectations are whenever oxygen therapy is initiated, the clinician needs to document the reason why oxygen was started. Also, what the blood oxygen levels were prior and after oxygen therapy, and what was the patient’s clinical response.”