Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on March 18, 2025 through March 20, 2025 and completed offsite on March 24, 2025, Clarion Dialysis Center - Clarion, was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey March 18, 2025 through March 20, 2025 and completed offsite March 24, 2025, Clarion Dialysis Center - Clarion, was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(b)(2) STANDARD IC-ASEPTIC TECHNIQUES FOR IV MEDS Name - Component - 00 [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
Observations:
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.
Plan of Correction:An in-service was given to all Direct Patient Care (DPC) staff on 4/2/2025 by the Clinic Manager (CM) regarding the importance of following facility policy regarding the monitoring of expirations dates on all medications including the change of procedure per below. Procedure IC 61 was updated to reflect A medication list containing all medications in the facility will be maintained and expiration dates monitored on a monthly basis. A box of medication that is opened will have each vial in the box checked for expiration date. Unopened boxes of medication will have the expiration date on the box checked until opened and documented on the medication inventory list. Medications will not be consolidated from two different boxes to one box of the same medicine. Only one box of each medication should be opened at any given time. The Clinic Manager will ensure compliance by reviewing the monthly medication inventory list and medication expiration dates prior to the monthly Quality Assurance Performance Improvement (QAPI) meeting and document on the CM Monitoring Tool her findings. The CM Monitoring Tool is to be brought to the monthly QAPI meetings for review and all findings discussed by the committee. Further action will be taken as deemed appropriate, which could include more frequent monitoring (bi-weekly), more staff education or disciplinary action.
494.30(a)(2) STANDARD IC-STAFF EDUCATION-CATHETERS/CATHETER CARE Name - Component - 00 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].
Observations:
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."
Plan of Correction:The facility policy IC 13 was updated to reflect the manufacturers guidelines in use of Chloraprep swabs for catheter care to reflect the back and forth strokes for 30 seconds. An in-service was given to all Direct Patient Care (DPC) staff on 3/25/2025 by Clinic Manager (CM) reviewing the updated procedure change and demonstration of catheter care with emphasis on maintaining aseptic technique during catheter care. All Direct Patient Care (DPC) staff will be observed performing catheter site care by the Clinic Manager and each DPC staff member will have a certificate of competency signed by the Clinic Manager and the Medical Director in their personnel file by 4/30/2025. The Clinic Manager will ensure compliance by observation of catheter care weekly for 6 weeks by each DPC staff with documentation of observations on the Clinic Manager monitoring tool. All breaks in procedure will be immediately addressed by the Clinic Manager. The Clinic Manager will ensure continued compliance through direct observation utilizing the Monthly Infection Control Audit. The audit will be reviewed monthly prior to the Quality Assurance Performance Improvement (QAPI) meeting. All findings will be addressed at the monthly QAPI meeting where additional action will be taken as deemed appropriate, such as additional training, continuing the weekly observations and documentation or if trends are identified, disciplinary action.
494.90(a)(1) STANDARD POC-ACHIEVE ADEQUATE CLEARANCE Name - Component - 00 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.
Observations:
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.
Plan of Correction:An in-service was given to all of the Direct Patient Care (DPC) staff on 4/4/2025 by the Clinic Manager (CM) reinforcing that every part of the dialysis prescription must be supported by a physician order or justified in writing on the treatment sheet as to why the order was not carried out as ordered. This includes Blood Flow Rates (BFR). If the BFR cannot be achieved as ordered, it needs to be documented in the medical record with the reason that the prescribed BFR could not be obtained and the charge nurse notified. The charge nurse must perform and document an assessment. If the BFR cannot be achieved as ordered repeatedly, the physician will be notified and a new BFR ordered. Documentation to this effect will be placed in the patient's medical record. Progress to achieving the maximum BFR needs to be addressed on the Comprehensive Assessment and Plan of Care (CA/POC). The Nurse in Charge, after each shift of patients is on treatment, is to round on each patient to make sure that they are receiving the correct BFR as ordered or justification documented and nursing assessment performed. This will be documented on the Charge Nurse Rounding Log during rounds, the Nurse in Charge is to review treatment sheets upon completion of treatment to verify the patient's ran on their prescribed BFR as ordered by the physician or justification is noted and a nursing assessment documented. Any findings are to be reported to the CM and if repeated inability to obtain ordered BFR, reported to the physician for a new BFR order or other orders per the MD. . The Clinic Manager will ensure compliance through review of this rounding tool and will also review one day of treatment records weekly for 6 weeks to ensure that the BFR is being delivered as prescribed or justified. This review will be documented on the CM Monitoring Tool. All findings from the CN and CM tools will be brought to the monthly Quality Assurance Performance Improvement (QAPI) meeting for review and further action will be taken as deemed appropriate by the committee.
494.150(c)(2)(i) STANDARD MD RESP-ENSURE ALL ADHERE TO P&P Name - Component - 00 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;
Observations:
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.
Plan of Correction:The Vice President of Clinical and Regulatory met with the Medical Director on 4/5/2025 to review the responsibilities of the position of medical director. Emphasis was placed on the responsibility of ensuring that all policies and procedures relative to patient admissions, patient care, infection control and safety are adhered to by all staff that treats patients in the facility including physicians, non-physician providers, registered nurses and patient care technicians. The Medical Director is responsible for ensuring that all staff are following the facility policies including the management of treatment adherence especially related to hypotension pre/during and post treatment. The DPC staff was in-serviced on 4/04/25 by the Clinic Manager in regard to patients presenting with hypotension of 20 or more points pre/during or post treatment. The DPC staff will notify the Charge RN and document this notification. The charge RN will assess the patient for interventions needed by following the standing orders (hypotension procedure IC 34) and if no response in 10 minutes the attending physician will be notified for further orders. If patient continues to be hypotensive for consecutive treatments the charge RN will notify the Clinic Manager. The Clinic Manager will bring this to the attention of the Medical Director for review and a Comprehensive Assessment and Plan of Care (CA/POC) will be implemented until the patient is declared stable. The Charge nurse will review and complete the Charge Nurse Daily Round Sheet by reviewing patient treatment sheets after each shift to identify any areas that were not addressed with BP management during treatment. If any deficiencies are identified the charge nurse will report to the Clinic Manager for further action. The Clinic Manager will ensure compliance by completing an audit of all treatment sheets for one day once per week for 6 weeks to ensure notification, documentation and intervention of hypotension is addressed per policy. The audits will be documented on the CM Monitoring Tool. Any deficiencies identified will be immediately presented to the Medical Director for action to be taken. All findings from the CN and CM tools will be brought to the monthly Quality Assurance Performance Improvement (QAPI) meeting for review and further action will be taken as deemed appropriate by the committee.
|