Fkc - West Des Moines

“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: 44475 Based on observation, facility policy, and staff interviews, the facility failed to ensure supplies used for patient care were not expired. At the time of the survey, the End Stage Renal Disease (ESRD) facility reported a census of 59 in center hemodialysis patients, 29 peritoneal dialysis patients, and 28 home hemodialysis patients. Findings include: 1. The “Storage of Supplies” policy published on 4/5/21 directed, in part, the purpose of this policy is to provide guidelines for storage and handling of supplies. Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not expired, contaminated, or damaged. Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date. 2. The “Expiration Dates Sterile Supplies” policy published 7/4/12 directed, in part, this policy provides guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date. Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached expiration date. 3. Observation on 8/27/25 starting at 10:35 AM until 12:15 PM revealed the following: 6 gold lab tubes, in the consultation room in the home therapy area of the facility, that expired 7/31/25; in the med (medication) prep (preparation) room in the home therapy unit 6 1mL (milliliter) syringes with needles attached that expired 4/30/25; in the supply area by the water room an open box containing 48 extension sets expired on 8/31/24. 4. During a tour of the in-center treatment floor on 8/27/25 at 11:40 AM, 1 of 1 bottle of blood leak test strips were observed with an expiration date of 6/30/25. 5. In an interview on 8/27/25 at 12:15 AM, Registered Nurse (RN) C acknowledged the expiration date on the blood leak test strips indicating they should be replaced. RN C proceeded to bring the bottle to Staff B to be replaced. 51639 6. In an interview on 8/27/25 at 11:38 AM, Staff A, Home Program Manager, reported that the PCT (patient care technician) for the home therapy unit checks for expired supplies monthly. Staff A agreed that the expiration supplies found in the home therapy unit were expired.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 36083 Based on policy and records review, and staff interviews, the facility failed to ensure: 1) Testing of total chlorine in a timely manner for 6 incidents in the last 3 months. (Refer to V196). The facility reported a census of 51 hemodialysis patients at the time of the survey. The cumulative effect of this failure resulted in the facility’s inability to ensure safe water and dialysate for the treatments of the ESRD (End Stage Renal Disease) in-center hemodialysis patients.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 51639 Based on policy review, record review, and interviews, the facility failed to verify hemodialysis prescriptions for 4 of 4 patients (Patient #2, Patient #5, Patient #6, and Patient #7) returning from hospital admissions and prior to initiation of treatment in the dialysis clinic. (Refer to V 503) At the time of the survey, the facility staff reported an in-center hemodialysis patient census of 51. The cumulative effect of these systemic failures and deficient practices in Patient Assessment resulted in the facility’s inability to ensure the safe provision of care to the ESRD (End Stage Renal Disease) patients.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 36083 Based on document review, and staff interviews, the facility failed to test for total chlorine every 4 hours while patients were on hemodialysis for 6 incidents in the last 2 months (from 2/28/25 through 4/23/25). Findings include: 1. Review of the Carbon Filtration Monitoring for Incenter Water Systems Policy, dated 2/3/25, showed that total chlorine tests must be completed within 4 hours. The policy also provides if staff are unable to perform testing within 4 hours of the previous test, hemodialysis treatments must be discontinued, and staff must follow patient assessment and monitoring policies. The policy directs 2 trained staff members (1 being a nurse) must then be present to perform and verify the total chlorine testing and document results in the total chlorine test log. 2. Review of the facility’s total chlorine log showed that dialysis water was not tested for total chlorine every 4 hours as required, on the following dates: a) 4/1/25 from 5:00 AM to 12:26 PM (7 hours and 26 minutes, and from 12:26 PM to 4:52 PM (4 hours and 30 minutes); b) 3/20/25 from 8:58 AM to 1:12 PM (4 hours and 14 minutes); c) 3/11/25 from 9:00 AM to 2:30 PM (5 hours and 30 minutes); d) 2/25/25 from 12:06 PM to 4:33 PM (4 hours and 27 minutes); e) 2/20/25 from 12:15 PM to 4:26 PM (4 hours and 11 minutes). 3. During an interview on 4/24/25 at 12:03 PM, Registered Nurse (RN) B, stated that a patient care technician (PCT) would be assigned to do the total chlorine test and a nurse will co-sign that the test was completed. RN B stated that total chlorine tests should be performed within every 4 hours. However, RN B also verified there were instances when the tests exceeded the 4-hour required intervals. 4. During interview on 4/24/25 at 12:21 PM, PCT I indicated responsibility includes testing for total chlorine when opening the water system in the morning, and that the tests should be done every 4 hours thereafter. PCT I stated there were times the total chlorine tests were not done timely when staff were “busy getting patients off treatment at the same time.” PCT I also stated facility policy provides that when they are unable to do total chlorine test within 4 hours, “we are supposed to stop treatment and notify clinic manager and the biomed, but we have not done that.” 5. During interview on 4/24/25 at 1:01 PM, PCT C verified that total chlorine tests were not always done every 4 hours. PCT C stated, “sometimes we are busy with take-offs, and forget the water went off.” PCT C said they are supposed to do the tests every 4 hours. 6. During interview on 4/24/25 at 3:15 PM, the biomedical technician (BT) indicated an ongoing problem with the timeliness of total chlorine testing. The BT stated “error reports” were pulled out monthly and showed late total chlorine tests. The BT stated staff did not call or report to him whenever these late tests occurred. 7. During an interview on 4/24/25 at 4:30 PM, the Clinic Manager (CM) acknowledged that timely total chlorine testing is “extremely important.” The CM also stated expectations for staff members to follow the facility’s policy regarding testing for total chlorine.”

“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: 36083 Based on policy review, record review, and interviews, the facility failed to verify hemodialysis prescriptions of 4 of 4 patients (Patient #2, Patient #5, Patient #6, and Patient #7) returning from hospital admission and prior to initiation of treatment in the dialysis clinic. Failure to verify the dialysis prescription post hospitalization before return to the dialysis facility could potentially cause the staff to deliver a dialysis prescription inappropriate for the patient’s current health status. Hospitalized patients can experience significant health changes during hospitalization. Staff should not assume the patient would dialyze using the same dialysis prescription prior to hospitalization. Using the incorrect dialysis prescription for the patient’s current health status could potentially cause adverse outcomes, severe illness or death for the dialysis patient. At the time of the survey, the facility staff reported an in-center hemodialysis patient census of 51. Findings include: 1. The facility policy 45113, titled, “Care Transitions” published 7/05/22, states in part, “...FKC (Fresenius Kidney Care) licensed nursing staff will communicate with other FKC and Non-FKC Inpatient and Outpatient staff prior to the next scheduled outpatient or in-patient dialysis treatment to provide continuity of patient care...” 2. Review of the Hospital medical records for Patient #2 showed Patient #2 was admitted to the hospital for a fall after dialysis on 3/12/25. The medical record went on to show Patient #2 was diagnosed with a subdural hematoma. The Hospital Medical record also showed on 3/15/25 at 9:00 AM Patient #2 left the hospital Against Medical Advice [(AMA). AMA refers to a patient ’ s decision to leave the hospital before the treating physician recommends discharge.] 3. Review of Patient #2’s dialysis medical records and dialysis treatment flowsheets showed the following. a. The dialysis treatment flowsheet dated 3/12/25 (the last dialysis treatment before hospitalization) included a dialysis treatment prescription to include in part a K2 (Potassium), Ca. 2.5 (Calcium), Na 138 (Sodium), BFR 350 (Blood Flow Rate), DFR 800 (Dialysate Flow Rate), Bicarb 34 (Bicarbonate), 3 hours 30 minutes (Dialysis Treatment Time), EDW 56.2 (Estimated Dry Weight), Heparin 3000 Bolus (the administration of a concentrated dose of medication or fluid directly into a vein) and 2000 Intermittent (The units given during the course of the dialysis treatment). b. On 3/17/25 at 6:05 AM Patient #2’s dialysis treatment was initiated. c. On 3/17/25 at 6:06 AM PCT (Patient Care Technician) C documented on the dialysis treatment flowsheet Patient #2 was hospitalized on 3/12/25 to 3/14/25. PCT C also documented no new findings regarding falls or injuries for Patient #2 since the last dialysis treatment. d. On 3/17/25 at 9:00 AM, Registered Nurse (RN) B documented in part, Patient #2’s “last dialysis treatment was on Wed. 3/12/25.” RN B also documented a verbal order was received from the provider (Nurse Practitioner H) to dialyze Patient #2 with previous dialysis order and settings. Review of Patient #2 ’ s medical records and dialysis treatment flowsheets show that Patient #2 ’ s previous dialysis treatment was 3/12/25. e. On 3/17/25 at 11:17 AM, RN B documented, “HD (Hemodialysis) treatment completed as prescribed.” Closer review of Patient #2’s medical record and dialysis treatment flowsheet lacked documentation that reflected Patient #2 ’ s provider was contacted prior to dialysis to ensure Patient #2’s dialysis prescription was appropriate for use. 4. The document titled, Absence and Hospitalization, with a date range from 1/1/25 to 4/14/25, showed Patient #5’s hospitalization from 12/23/24 to 1/1/25. The document also identified Patient #5’s reason for hospitalization was sepsis (a bacterial infection). 5. Patient #5’s treatment flowsheet dated 1/2/25, indicated treatment a day after hospital discharge. The treatment flowsheet showed Patient #5’s central venous catheter was active or in use. The treatment flowsheet showed Patient #5’s treatment orders including a blood flow rate (BFR) of 450. However, the pre-dialysis vitals and evaluation section did not indicate assessment related to recent hospitalization, wherein the space for noting whether Patient #5 had been hospitalized since the last treatment, including the admit and discharge date, were all left blank. The treatment flowsheet also showed that Patient #5 completed treatment with a BFR of 400, instead of 450 as ordered. 6. The document titled, Absence and Hospitalization, with a date range from 1/1/25 to 4/14/25, showed Patient #6’s hospital admission on 3/12/25 to 3/13/25, due to weakness and ascites (buildup of fluid in the abdominal cavity). 7. Patient #6’s treatment flowsheet dated 3/14/25, indicated dialysis treatment the day following discharge from the hospital. The treatment flowsheet showed hemodialysis orders including a target weight of 106 kilograms. The pre-dialysis vitals and evaluation section indicated Patient #6 was hospitalized from 3/11/25 to 3/12/25, which were inconsistent with the Absence and Hospitalization log information. 8. The document titled, Absence and Hospitalization, dated 1/1/25 to 4/14/25, showed that Patient #7 was hospitalized from 2/25/25 to 3/24/25, due to weakness. 9. Patient #7’s treatment flowsheet showed completion of treatment on 3/25/25, which was the day immediately following hospital admission. The pre-dialysis vitals and evaluation section indicated that Patient #7 was hospitalized with an admit date of 2/22/25, and a discharge date of 3/22/25, which was different from the discharge date noted in the Absence and Hospitalization log. 10. During an interview on 4/16/25 at 10:55 AM, the (Nurse Practitioner NP stated that the facility staff notified (NP) about Patient #2’s blood pressure issues and Patient #2’s return from the hospital on 3/17/25 at 9:00 AM (3 hours and 5 minutes from initiation of treatment). The NP denied being notified of Patient #2’s hospital admission diagnosis. 11. During an interview on 4/16/25 at 11:11 AM, the medical director (MD) stated, “typically we want to have a record from the hospital reviewed by staff in order to know the discharge summary including diagnosis and manner of discharge.” The MD also reported that staff members are expected to call the nephrology providers and review hospital admission diagnosis and dialysis orders before starting patients on treatments. 12. On 4/16/25 at 3:09 PM, the charge nurse (CN) reported that there was lack of documentation to show dialysis orders were reviewed prior to initiation of dialysis treatments after their respective hospitalizations for the following patients: Patient #5 for hospitalization with a discharge date of 1/1/25 and a return for treatment dated 1/2/25; Patient #6 for hospitalization with a discharge date of 3/13/25 and a return for dialysis treatment on 3/14/25; and Patient #7 who was discharged from the hospital on 3/24/25, and had dialysis treatment on 3/25/25. The CN stated dialysis orders should have been reviewed first before starting the patients’ dialysis treatments. 51639”