Clarion Dialysis Center

“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: 44820 Based on a review of facility policy/procedure, treatment area observations, and an interview with the facility administrator and clinic manager, the facility failed to ensure expired items were discarded one (1) of 0ne (1) observations (OBS). (OBS#1-#8) Findings include: A review was conducted of facility policy on March 18, 2025 at approximately 3:30 p.m. Policy/Procedure Name: Medication Administration... Policy Number: IC61... Purpose:... To administerr and store medications in a safe manner according to manufacturer’s recommendations... 21. Expired Medications will be disposed of according to state and local laws...” Observations conducted in the patient treatment area on March 18, 2025 between approximately 9:30 a.m. and 1:00 p.m. revealed the following: OBS#1: On March 18, 2025 at approximately 9:30 a.m. the following expired items were observed in the treatment area medication supply: Eight (8) Diphenhydramine HCL injection 50mg/ml (1 ml vial) expired 2/2024; LOT#’s 022016. An interview with the clinic manager and facility Administrator on March 18, 2025 at approximately 4:00 p.m. confirmed the above findings.”

“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: 44820 Based upon a review of review of manufacturer’s direction for use, treatment area observations (OBS), and an interview with the Charge Nurse, Nurse Manager, Staff Nurse and Facility Administrator, facility failed to ensure staff followed and maintained aseptic technique for the care of vascular accesses, including intravascular catheters, for two (2) of two (2) observations (OBS #1 and OBS #2). Findings include: On 3/19/25 at approximately 1:15 p.m. a review of Manufacturer’s direction for use - Chloraprep One-Step (2% Chlorahexidine gluconate/ 70% Isopropyl alcohol) antiseptic swab states”...dry surgical sites (e.g., abdomen or arm): use gentle repeated back-and-forth strokes for 30 seconds...” Observations conducted in patient treatment area on 3/19/25 between approximately 9:30 a.m.-12:00 p.m. revealed the following: OBS #1: During observation of Central Venous Catheter (CVC) Exit Site Care performed on 3/19/25 at approximately 9:50 a.m., station #5, Employee (EMP) #7 cleansed area around the CVC exit site, starting from the insertion site and moving outward in a spiral circular motion with a Chloraprep One-Step (Chlorahexidine swabstick) antiseptic swab. Interview with EMP#7 states “we were trained to use the circular technique starting at insertion site and working outward in larger circles to clean the area.” OBS #2: During observation of CVC Exit Site Care performed on 3/19/25 at approximately 10:40 a.m., station #10, EMP #4 cleansed area around the CVC exit site, starting from the insertion site and moving outward in a spiral circular motion with a Chloraprep One-Step (Chlorahexidine swabstick) antiseptic swab. Interview with EMP#4 states “To clean the catheter site we use a spiral technique with the swab.” 3/19/25 at approximately 11:00 a.m. an interview with Charge Nurse revealed “We used to do a back and forth motion but when new management came in they made us change it.” 3/20/25 at approximately 2:30 p.m. an interview with Nurse Manager and Facility Administrator confirmed the above findings. Facility Administrator states “The procedure is a circular motion from inside, closest entry point, to outside away from the catheter making a spiral and we followed the KDQOL website guidance. I see that the manufacturer directions state otherwise. The information is contradicting in the guidance.””

“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: 44820 Based on a review of facility policies, review of job descriptions, review of Medical records (MRs) and an interview with clinic manager, the facility failed to ensure treatments were delivered in accordance with the dialysis prescriptions ordered by the physician and failed to follow policy and procedure for three (3) of four (4) MRs reviewed (MR#2, MR#3 and MR#4). Findings included: Review of facility policy on 3/20/25 at approximately 9:00 AM revealed: “Policy/Procedure Name: Safety Checks ... Policy Number: IC10 ... Purpose ... to ensure the treatment is progressing properly and safely ... Policy ... 5. Patient Monitoring during treatment ... Verify the prescribed blood flow is obtained ... 6. Correct any issues found and notify Charge RN ... “ Review of job description on 3/20/25 at approximately 3:00 PM revealed: “ Medical Director Job Description ... General Responsibilities: The Medical Director is directly responsible for the delivery of patient care and outcomes in the facility ... 2. Ensures that all 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 non-physician providers ... 14. Assures adequate monitoring of the patient and the dialysis process which includes, but not limited to staffing ratios, assessments of patients, reporting of changes in the patient ’ s condition and documentation ... “ Review of MRs conducted on March 20, 2025, at approximately 1:00pm and March 24, 2025, at approximately 12:30 pm revealed the following: MR#2, admitted on 11/25/24. Treatment flowsheets dates reviewed 2/21/25 through 3/14/25 revealed the following: Treatment date: 3/5/25 - Blood Flow Rate (BFR) 450ml/min prescribed by physician; treatment initiated at 10:52 AM - BFR 185ml/min documented: 11:32 AM - BFR 300ml/min documented. 12:01 PM - BFR 300ml/min documented 12:31 PM - BFR 325ml/min documented 13:01 PM - BFR 350ml/min documented 13:31 PM - BFR 350ml/min documented 14:01 PM - BFR 350ml/min documented 14:13 PM - BFR 350ml/min documented 14:13 PM - treatment terminated. Treatment sheet contained no evidence of Charge RN notification for inability to achieve/administer prescribed dialysis orders. No documentation of physician notification regarding dialysis prescription not being achieved or administered as prescribed. MR#3, admitted on 9/25/24, treatment flowsheets dates reviewed 2/17/25 through 3/17/25 revealed the following: Treatment date: 3/7/25 - Blood Flow Rate (BFR) 500ml/min prescribed by physician; treatment initiated at 5:59 AM - BFR 450ml/min documented: 6:01 AM - BFR 450ml/min documented. 6:31 AM - BFR 450ml/min documented 7:01 AM - BFR 450ml/min documented 7:31 AM through 9:15 AM - BFR 500ml/min documented 9:15 AM - treatment terminated. Treatment sheet contained no evidence of Charge RN notification for inability to achieve/administer prescribed dialysis orders. No documentation of physician notification regarding dialysis prescription not being achieved or administered as prescribed. MR#4, admitted on 3/4/24: treatment flowsheets dates reviewed 2/26/25 through 3/12/25 revealed the following: Treatment date: 2/26/25 - Blood Flow Rate (BFR) 350ml/min prescribed by physician; treatment initiated at 6:32 AM - BFR 200ml/min documented: 6:32 AM through 9:40 AM - BFR 200ml/min documented. 9:40 AM - treatment terminated. Treatment sheet contained no evidence of Charge RN notification for inability to achieve/administer prescribed dialysis orders. No documentation of physician notification regarding dialysis prescription not being achieved or administered as prescribed. Treatment date: 2/28/25 - Blood Flow Rate (BFR) 350ml/min prescribed by physician; treatment initiated at 6:48 AM - BFR 250ml/min documented: 7:00 AM - BFR 250ml/min documented. 7:30 PM - BFR 250ml/min documented 8:01 AM - BFR 350ml/min documented 8:30 AM - BFR 200ml/min documented 9:00 AM - BFR 200ml/min documented 9:30 AM - BFR 200ml/min documented 9:54 AM - treatment terminated. Treatment sheet contained no evidence of Charge RN notification for inability to achieve/administer prescribed dialysis orders. No documentation of physician notification regarding dialysis prescription not being achieved or administered as prescribed. Treatment date: 3/3/25 - Blood Flow Rate (BFR) 350ml/min prescribed by physician; treatment initiated at 6:52 AM - BFR 300ml/min documented: 7:01 AM - BFR 300ml/min documented. 7:30 PM - BFR 300ml/min documented 8:33 AM - BFR 300ml/min documented 8:42 AM - BFR 300ml/min documented 9:34 AM - BFR 300ml/min documented 9:54 AM - treatment terminated. Treatment sheet contained no evidence of Charge RN notification for inability to achieve/administer prescribed dialysis orders. No documentation of physician notification regarding dialysis prescription not being achieved or administered as prescribed. Treatment date: 3/7/25 - Blood Flow Rate (BFR) 350ml/min prescribed by physician; treatment initiated at 6:38 AM - BFR 300ml/min documented: 6:38 AM through 9:40 AM - BFR 300ml/min documented. 9:40 AM - treatment terminated. Treatment sheet contained no evidence of Charge RN notification for inability to achieve/administer prescribed dialysis orders. No documentation of physician notification regarding dialysis prescription not being achieved or administered as prescribed. Treatment date: 3/10/25 - Blood Flow Rate (BFR) 350ml/min prescribed by physician; treatment initiated at 11:00 AM - BFR 300ml/min documented: 11:30 - BFR 200ml/min documented 11:45AM - treatment terminated. Treatment sheet contained no evidence of Charge RN notification for inability to achieve/administer prescribed dialysis orders. No documentation of physician notification regarding dialysis prescription not being achieved or administered as prescribed. Treatment date: 3/12/25 - Blood Flow Rate (BFR) 350ml/min prescribed by physician; treatment initiated at 6:30 AM - BFR 300ml/min documented: 7:00 AM - BFR 300ml/min documented. 7:30 PM - BFR 300ml/min documented 8:00 AM - BFR 250ml/min documented 8:30 AM - BFR 250ml/min documented 9:00 AM - BFR 200ml/min documented 9:30 AM - treatment terminated. Treatment sheet contained no evidence of Charge RN notification for inability to achieve/administer prescribed dialysis orders. No documentation of physician notification regarding dialysis prescription not being achieved or administered as prescribed. An interview with the clinical manager on 3/25/25 at approximately 8:30 AM confirmed the above findings.”

“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: 44820 Based on a review of facility policies/procedure, medical records (MR), and employee interviews, the facility failed to follow its’ policy for managing treatment adherence for two (2) of four (4) MR’s reviewed. (MR#1 and MR#2) Findings included: Review of agency Policy on March 19, 2025, at approximately 1:00 pm revealed: “Policy/Procedure name: Hypotension... Policy Number: IC34... Effective date: 3-01-2024... Purpose: To prevent a hypotensive episode for patient and avoid injury, potential access clotting, etc... Policy: 1. Monitor BP pre, during and post treatment... Procedure: ... 4. If systolic BP has dropped 20 points from previous reading, notify RN...” A review of medical records took place March 20, 2025 at approximately 1:00pm and March 24, 2025 at approximately 12:30 pm revealed the following: MR #1, Start of Care (SOC) date: 1/15/24 - Dates reviewed: 2/19/25 to 3/17/25. Documentation revealed: Treatment Date (TD) 2/19/25 - 10:30 a.m. Blood Pressure (BP) 126/62; 11:00 a.m. BP 102/56 -systolic BP decreased 24 points - no documentation of RN notified. TD 2/28/25 - 7:34 a.m. BP 187/90; 8:00 a.m. BP 166/83 - Systolic BP decreased 21 points - no documentation of RN notified. TD 3/17/25 - 7:31 a.m. BP 158/77; 8:01 a.m. BP 115/54 - systolic BP decreased 43 points - no documentation of RN notified. MR #2, SOC date: 11/25/24 - Dates reviewed: 2/21/25 to 3/14/25. Documentation revealed: Treatment Date (TD) 2/19/25 - 10:30 a.m. Blood Pressure (BP) 126/62; 11:00 a.m. BP 102/56 - sytolic BP decreased 24 points - no documentation of RN notified. TD 2/28/25 - 12:00 p.m. BP 123/64; 12:30 p.m. BP 98/55 - systolic BP decreased 25 points - no documentation of RN notified. An interview with the clinic manager and Vice President of Clinical and Regulatory on March 20, 2025, at approximately 3:30 p.m. confirmed the above findings.”