Le Mars Area Dialysis Services

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 50072 Based on document review, observation and staff interview, the facility did not ensure to discard outdated or expired supplies to prevent their use. Failure to ensure expired supplies are removed from the facility could result in their use beyond the date the manufacturer can guarantee efficacy. At the time of the survey, the facility reported a census of 20 in-center hemodialysis patients. 1. The facility Document titled, “ALL TEST STRIPS AND SOLUTIONS, WHEN OPENED, MUST BE LABELED WITH THE EXPIRATION DATE. PLEASE ADHERE TO THE FOLLOWING MANUFACTURER’S EXPIRATIONS”, revised on 7/19/2007, indicates that residual peroxide test strips (Minncare) expire 6 months from the date they were opened or manufacturer’s expiration date (whichever comes first). 2. The policy titled, EXPIRATION DATES STERILE SUPPLIES, published 7/04/2012, indicates that sterile items will be checked before they are used to ensure they have not expired and should be appropriately disposed of once the expiration date has been reached. 3.Observations on 01/08/25 at 9:27 am showed the following outdated items located in the patient treatment area: -4 IV Administration Sets expired 12/06/24; -1 bottle of Sevelamer Carbonate Tablets 800 mg. (commonly used to lower phosphorus levels in the blood) expired May 2022; -1 Safety Glide Needle 22G x 1 1/2 expired 11/30/23; -Aniosgel 85NPC hand sanitizing gel hand rub expired 05/24; -10 doses Retacrit Epoetin 20,000 units / mL (medication used to treat anemia) expired 10/31/24; -34 BD Vacutainer PST Gel and Lithium Heparin blood collection tubes (used to collect blood samples) expired 10/31/24. 4. During a tour of the treatment floor on 1/08/2025 at 9:40 AM showed one bottle of expired Minncare test strips (a test strip used to detect disinfectant) and one bottle of expired blood leak (Test Strips used to test for blood leaks in the dialysis machine) test strips located at the nurse’s station. Both bottles were marked with an expiration date of 11/13/2024. 5. Observation on 01/09/25 at 4:30 pm showed the following outdated item located in the patient waiting area: -Aniosgel 85NPC hand sanitizing gel hand rub expired 11/23. 6. During an interview on 1/08/2025 at 9:40 AM, staff E reported both bottles of test strips (Minncare and blood leak) should have been discarded. Staff E then discarded both bottles of test strips. 7. During an interview with Staff C on 01/08/25 at10:30 am, they acknowledged the expiration dates on the items found in the facility. 51639”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 51639 Based on document review, observation and interview, the facility failed to ensure the calibration solutions for the pHoenix (an independent hand-held meter used to test the dialysis machine to ensure the machine is accurately mixing the dialysis solutions) meters were not expired. The use of an expired or outdated calibration solution could potentially result in utilizing a meter that is not accurate. Utilizing an inaccurate pHoenix meter could result in an undetected problem with the dialysis machine and the potential adverse patient reactions. The facility reported a census of 20 in-center hemodialysis patients at the time of the survey. 1. The policy titled, ALL TEST STRIPS AND SOLUTIONS, WHEN OPENED, MUST BE LABELED WITH THE EXPIRATION DATE. PLEASE ADHERE TO THE FOLLOWING MANUFACTURER’S EXPIRATIONS, revised on 7/19/2007, indicates that conductivity solutions for the pHoenix meter expire 30 days from the date they were opened or the manufacturer’s expiration date (whichever comes first). 2. The policy 94 0005 titled, TRI-STATION: DISINFECT, VERIFY, RINSE, revised 08/2009, indicates that the Neo-Care solution and conductivity solutions are to be used daily to calibrate the pHoenix meter. It also indicates that conductivity solutions should be replaced 30 days after opening, and that pH solutions should be replaced 90 days after opening. 3. On 1/8/2025 at 9:25 AM, an observation in the water treatment room showed multiple bottles of pHoenix meter calibration solutions at the designated pHoenix meter station labeled with expiration dates of 1/02/2025. These included 3 bottles of conductivity solution (one labeled as H&S Conductivity Standard Sol 150 us/cm, one labeled H&S Conductivity Standard Sol 50 ms/cm, and one labeled H&S Conductivity Standard Sol 1 ms/cm). Additional observation showed an opened bottle of solution labeled, “Neo-Care” (Neo-Care solution is used to maintain the sensors on a pHoenix Meter) that had no written opened date or expiration on the bottle. 4. During an interview on 1/8/2025 at 9:25 AM staff C reported the bottles are used daily to calibrate the pHoenix meters. Staff C went on to report the expired conductivity solutions were missed by the staff.”

“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: 44475 Based on facility policy, facility documents, medical record, and staff interview, the facility failed to ensure all patient dialysis prescriptions were verified with the facility physician prior to the patient ’ s returning to in center dialysis following hospitalization. Failure to verify the dialysis prescription following hospitalization and before returning to in center dialysis could potentially result in an incorrect dialysis prescription used for the dialysis teatment. This could potentially lead to poor patient outcomes. The facility reported a census of 20 in center hemodialysis (ICHD) patients at the time of the survey. Findings for review of 2 of 4 patients reviewed for hospitalization (Patient #2 and #3) include: 1. Review of the facility policy titled “Nursing Supervision and Delegation” dated 11/6/23 directed, in pertinent part, the following criteria can be used as a guideline to identify when to refer a patient to the Team Leader/Charge Nurse for further assessment pre, during, or post treatment. Hospitalization: First treatment back from a hospitalization, recent hospitalization, or medical procedure. 2. During the survey, the facility provided a list of patients that had been hospitalized. Review of the list revealed: Patient #2 was hospitalized from 2/21/24 to 2/27/24, 5/1/24 to 5/3/24, and 6/7/24 to 6/28/24. Patient #3 was hospitalized from 11/18/24 to 11/26/24. 3. In a concurrent medical record review and interview on 1/14/25 at 10:39 AM, Staff C, Registered Nurse (RN) and Charge Nurse and Staff D, RN and Clinical Manager were not able to locate documentation that the patients ’ dialysis prescriptions were verified before their first treatment at the facility following each hospitalization. Staff C reported that she always contacts the physician to verify the prescription before resuming treatment with a patient that has been hospitalized.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 44475 Based on facility policy, facility documents, medical record, and staff interview, the facility failed to conduct tuberculin (TB) testing of a patient in accordance with facility policy. Failure to ensure patients were screened for TB increases the patient ’ s and/or staff ’ s risk of acquiring and/or transmitting the infection. The facility staff reported an in center hemodialysis (ICHD) patient census of 20 at the time of the survey. Findings for 1 of 2 new patient admissions (Patient #3) include: 1. The facility policy titled “Patient Tuberculosis Testing” dated 2/5/24 directed, in pertinent part, on admission to review the medical records of each patient to determine if they have received TB testing within the last year. Patients who have no documented TB test within the last year will be tested using the TST (Tuberculin Skin Test). 2. During the survey, the facility provided a list of newly admitted patients. Review of the list revealed that Patient #3 was admitted to the facility on 10/14/24 as a transfer from another ESRD (End Stage Renal Disease) provider. 3. In a concurrent medical record review and interview on 1/14/25 at 10:41 AM, Staff D, Registered Nurse (RN) and Clinical Manager was unable to locate documentation of Patient #3 ’ s TB test in the patient ’ s medical record. In an interview on 1/14/25 at 12:07 PM, Staff D reported that the patient has not had TB screening since 2022.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 36083 Based on documents review, and staff interviews, the facility failed to report an occurrence regarding clotted vascular access for tracking and trending under the facility’s QAPI (Quality Assessment and Performance Improvement) program for 1 of 1 patient (Patient #4) sample reviewed for adverse occurrence reports. At the time of the survey, the facility reported a census of 20 in-center hemodialysis (ICHD) patients. Findings include: 1. The policy # 61025 version 2, titled, Patient Safety Event and Documentation, published on 2/6/23, notes the policy’s purposes to manage “all patient safety related events” and to promote a culture of patient safety. The policy indicates staff are encouraged to report patient events with an understanding that event review is focused on opportunities for learning and improving the safety of patients. The policy defines a safety event as one that results in mild to moderate patient clinical harm, not due to an underlying disease or condition and requires additional monitoring, intervention and/or medical care. The policy directs staff to document all patient events in a factual, complete, timely, and concise manner, and including documentation of an accurate recording of the event, times, interventions, and result of interventions. The policy also indicates that patient safety events should be reviewed during the QAPI program utilizing the “eQUIP Dashboard” in accordance with the QAPI policy. The policy further directs the facility to perform analysis of all events and complete all documentation in accordance with the QAPI process and tools. The policy listed clotting of an AVF (arteriovascular fistula) or AVG (arteriovenous graft) during dialysis that results in termination of treatment as an adverse event. 2. On 1/8/25 at 10:00 AM, Patient #4 reported during an interview that her AVF (Arterio-Venous Fistula is a surgically created blood vessel for the placement of dialysis needles) access site clotted and had to be replaced with a CVC (a Central Venous Catheter is a catheter inseted for dialysis). A review of Patient #4’s medical records showed that on 10/30/24, her “access was clotted” and was “unable to dialyze.” The medical records noted on 11/6/24 that Patient #4’s vascular access was “shut down” with unsuccessful attempts to declot. 3. On 1/13/25 at 3:30 PM, registered nurse (RN) C stated during an interview that Patient #4’s vascular access site (AVF) clotted sometime in “October or November” last year. RN C also stated she documented the details of the incident in Patient #4’s medical records but did not make a report of the incident to be reviewed in QAPI. 4. The facility’s document titled, “Adverse Events Reports” from 1/8/24 through 1/8/25, showed 7 incidents but did not show any reports regarding Patient #4’s clotted vascular access including the incident on 10/30/24. The QAPI records from 8/24 through 12/24 also did not show any report related to Patient #4’s clotted vascular access. 5. On 1/13/25 at 3:30 PM, RN C and the clinic manager (CM) verified the lack of information to show that Patient #4’s vascular access event was reported for review in the QAPI documents. The CM said clotted vascular access should be documented and reported as an occurrence according to facility policy. The CM also acknowledged the importance of reviewing trends of incidents under the QAPI program.”