Davita Cedar Valley Waverly Dialysis

“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: 50072 Based on review of policy, observations, and interview the facility failed to ensure staff performed hand hygience in accordance with the facility policy. The facility staff reported a hemodialysis patient census of 32 at the time of the survey. Failure to perform hand hygiene, following the removal of soiled gloves can lead to cross contamination of other surfaces and other patients, and potentially place all 32 patients receiving in center hemodialysis treatments at risk for infections. 1. Review of the facility policy titled INFECTION CONTROL FOR DIALYSIS FACILITIES, with the latest revision date of April 2023, reads in part, that: HAND HYGIENE 1) All teammates, Physicians and Non-Physician, will perform hand hygiene: A. Upon entering and exiting patient area, B. Prior to gloving and immediately after removal of gloves, C. After contamination with blood or other infectious material, D. After patient and dialysis delivery system contact, E. After interacting with wall boxes (i.e., plugging/unplugging acid/ bicarb lines from dialysis machine, changing acid types, when exchanging a dialysis machine) F. Between patients even if the contact is casual, G. Before touching clean areas such as supplies, supply cart and chairside keyboard/mouse ... 2. Observations on 09/30/24 at approximately 1:30 pm showed RN (Registered Nurse) B failed to perform hand hygiene prior to donning gloves and performing patient care. 3. Additional observations on 10/02/24 at 7:30 and 7:32 am showed PCT (Patient Care Technician) H failed to perform hand hygiene after removing gloves after patient care and prior to entering information at the computer. 4. During an interview with the Medical Director on 10/02/24 at 12:14 pm, they acknowledged that staff should be following proper infection control procedures in the dialysis center, including hand hygiene.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 36083 Based on review of facility policy and procedure, observations, and staff interviews, the facility failed to sanitize the medication injection ports of intravenous (IV) solution bags prior to access for 2 of 2 patients (Patient #6 and Patient #3) in the sample for observation of IV medication administration practices. At the time of the survey, the facility reported a census of 32 in-center hemodialysis patients. Findings include: 1. The procedure titled, “Preparation and Administration of Intravenous Medications Via IV Pump” dated April 2024 directs staff to observe aseptic technique when adding medication to the IV solution bag. 2. During observation on 9/30/24 at 2:00 PM, registered nurse (RN) F was in the process of preparing 1.5 grams of vancomycin for Patient #6. RN F took out an IV solution set (bag and tubing) and hanged the IV solution bag in the handle of a cabinet at the medication preparation area. RN F attached the IV tubing to the bag and primed by letting the solution flow down to the sink. After diluting the contents of the medications (contained in 2 vials), RN F took a 10 milliliter (ml) syringe and withdrew contents from the 1st vial (1 gram), but without first disinfecting the rubber port, she injected the medication into the IV solution bag. RN F took another 10 ml syringe and withdrew the remaining contents of the 1 gram vial, and injected the medication into the same IV solution bag without disinfecting the port. RN F took another 10 ml syringe, withdrew the contents of the 2nd vial (500 milligrams) and again did not wipe the injection port of the IV solution bag but injected the medication into the IV solution bag. 3. The Patient Summary Report for Patient #6 showed an order with a start date of 9/23/24 for Vancomycin (antibiotic) 1500 mg IV every treatment. The Treatment Details Report on 9/30/24 showed Patient #6 received Vancomycin 1500 mg intravenously. 4. During observation on 9/30/24 at 2:24 PM, RN F was in the process of preparing 25 grams of sodium thiosulfate for Patient #3. RN F opened the package of an IV solution bag, attached an IV tubing set and hooked the IV solution bag in a cabinet door handle, however, in the process of priming the tubing with the solution from the bag, RN F’s bare right hand got in contact with the rubber injection port of the solution bag. While the IV solution continued to drip-drain into the sink, RN F prepared the medication (sodium thiosulfate) dose from 2 vials. Thereafter, RN F touched the IV solution bag to verify amount of fluid, and stopped the priming. RN F withdrew the contents of the 1st vial into a syringe, and injected into the IV solution bag without first disinfecting the rubber injection port of the bag. RN F withdrew the contents of the 2nd vial into a new syringe, and again injected the medication into the IV solution bag but did not first disinfect the injection port. 5. The Patient Summary Report for Patient #3 showed an order for Sodium Thiosulfate 25 grams IV three times a week. The Treatment Details Report showed Patient #3 received the medication on 9/30/24 that was infused from 3:07 PM to 3:33 PM. 6. During interview on 9/30/24 at 2:32 PM, RN F verified she did not sanitize the injection ports of the solution bags. When asked if the injection ports need to be disinfected, RN F replied, “Probably!” RN F also acknowledged the importance of disinfecting the injection ports during the priming of the IV tubing and medication preparation. 7. During an interview on 10/2/24 at 8:20 AM, RN C stated that injection ports in the saline bags need to be “scrubbed” before accessing to inject medications into the solution bag.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 50072 Based on review of facility policy, observations, and interview, the facility failed to ensure staff performed infection control practices to minimize the spread of infections or bloodborne pathogens in the dialysis facility in accordance with the facility’s policy. The facility staff reported a hemodialysis patient census of 32 at the time of the survey. Failure to follow proper infection control practices has the potential to adversely affect all of the patients in the facility. 1. Review of the facility policy titled INFECTION CONTROL FOR DIALYSIS FACILITIES, with the latest revision date of April 2023, reads in part, that: DISINFECTION 13) At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g. dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreen; countertops) ... 2. Observations on 10/01/24 at 2:05 pm showed PCT (Patient Care Technician) D cleaned the dialysis treatment station trash receptacle with a disposable towel soaked in bleach solution. PCT D dropped the towel on the floor, picked it up and continued to wipe down the trash receptacle prior to discarding the dropped towel in the trash. 3. During an interview with the Medical Director on 10/02/24 at 12:14 pm, they acknowledged that staff should be following proper infection control procedures in the dialysis center and agreed if a disposable towel soaked in bleach solution is dropped on the floor, it should be discarded immediately. 4. During an interview with RN (Registered Nurse) C on 10/02/24 at 12:25 pm, they acknowledged, “If a wipe is dropped on the floor, it should be thrown away.””

“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 documents review, observations, and interviews, the facility did not ensure correct dialysis prescription for 1 of 4 patients (Patient #7) observed for prescription verification. The facility reported a census of 32 in-center hemodialysis patients at the time of the survey. Findings include: 1. The Policy # 1-03-08, titled, Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, dated April 2024, indicates that staff verify patient identity and prescriptions prior to the initiation of treatment. The policy provides that prescription components are confirmed by a licensed nurse within one hour of treatment initiation, to include verifying correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings. 2. The first step of Procedure # 1-03-081, titled, Treatment Initiation Utilizing B Braun Dialog+ Dialysis Delivery Systems with All Single Use Dialyzer Types and Streamline Blood Lines, dated October 2021, directs staff to verify that the correct dialysate concentrate is attached. The procedure also indicates treatment checks should be completed every 30 minutes. 3. During observation on 9/30/24 at 3:19 PM, Patient #7’s dialysis treatment was running with a blood flow rate (BFR) of 350. The patient care technician (PCT) D verified Patient #7’s prescribed BFR was 450. PCT D, who was present during the observation, reported they did not know whey the blood flow rate was not set according to the prescription. 4. Patient #7’s treatment details report dated 9/30/24, showed a prescription for BFR at 450. However, Patient #7 ran the whole treatment duration (3 hours and 30 minutes) with a BFR of 350, without documentation as to the reason for not following the dialysis prescription. 5. During interview on 10/1/24 at 4:30 PM, the facility administrator (FA) also verified Patient #7’s treatment details report showing the BFR prescription was not followed. 6. During interview on 10/2/24 at 12:15 PM, the medical director (MD) indicated that medical records should accurately reflect what transpired during patients’ treatments and for staff to report to him or nephrologist any deviation from dialysis orders.”

“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: 36083 Based on policy review, medical records review, observation, and interviews, the facility did not ensure to address abnormal findings indicative of increased fluid volume, such as post-treatment weights above the target weight, for 3 of 5 patients (Patient #1, Patient #3, and Patient #5) whose medical records were reviewed. In addition, the facility failed to address abnormal heart rate for 1 of 5 patients (Patient #3) in the sample of medical records reviewed. The facility reported a census of 32 dialysis patients at the time of the survey. Findings include: 1. The policy #1-03-08, titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” dated April 2024, directs staff members to obtain and document ongoing information about the patient before, during, and after treatment through data collection and nursing assessment. The policy notes the “information obtained will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge.” The policy shows a list of post treatment abnormal findings including post treatment weight above 1 kilogram (kg) from target weight, and heart rate of greater than 100 beats per minute. 2. The policy #1-14-01, titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” dated October 2024, provides the comprehensive assessment will be used to develop the patient’s treatment plan and expectations of care. The policy lists treatment criteria, including fluid management needs. The policy indicates the plan of care will address care and services to manage the patient’s volume status. 3. Patient #1’s treatment details report from 9/16/24 through 9/30/24, showed a target weight of 209.5 kg. However, the post treatment weights were above the target weight on the following dates: A. On 9/16/24, Patient #1’s post treatment weight of 210.5 kg. Patient #1 ended treatment with 1 kg above the target weight. B. On 9/23/24, Patient #1’s post treatment weight was 211.1 kg, which was 1.6 kg above the target weight. C. On 9/30/24, Patient #1’s post treatment weight was 212.7 kg, which was 3.2 kg above the target weight. The records lack evidence to show how the abnormal findings were addressed. 4. During observation for discontinuation of dialysis with central venous catheter (CVC) on 9/3024 at 3:45 PM, Patient #3 ended treatment complaining, “I can’t breathe.” Registered Nurse (RN) B administered oxygen via mask. 5. Patient #3’s treatment details report from 9/20/24 through 9/30/24, showed a target weight of 120.5 kg. However, the post treatment weights showed Patient #3 consistently ended treatment above the target weight, as follows: A. On 9/20/24, Patient #3’s post treatment weight was 122.2 kg, or 1.7 kg above the target weight. B. On 9/25/24, Patient #3’s post treatment weight was 121.7, which was 1.2 kg above the target weight. The pre and post treatment assessments indicated wheezes. C. On 9/27/24, Patient #3’s post treatment weight as 123.4 kg, which was 2.9 kg above the target weight. The pre treatment assessment indicated shortness of breath, and post treatment assessment indicated shortness of breath upon exertion. D. On 9/30/24, Patient #3’s post treatment weight was 124.6 kg or 4.1 kg above the target weight. The post treatment assessment also showed Patient #3 was short of breath, with rales on lower left and right areas of lungs. The treatment report indicated Patient #3’s use of oxygen at 3 liter per minute. The records did not show how the abnormal findings were addressed. 6. Patient #3’s treatment details report also showed increased heart rates on the following dates: A. On 9/16/24 at 11:52 AM, a patient care technician (PCT) D recorded Patient #3’s heart rate as 120, at 12:51 PM as 102, and at 1:22 PM as 113. B. On 9/20/24, Patient #3’s heart rate remained above 100 for the whole duration of the treatment, and post treatment heart was 125. The records lacked evidence of how the abnormal heart rates were addressed. 7. Patient #5’s treatment details report from 9/20/24 to 9/30/24 showed a target weight of 104 kg. However, the post treatment weights were above the target weight, as follows: A. On 9/20/24, Patient #5’s post treatment weight was 105.7 kg, which was 1.7 kg above the target weight. B. On 9/23/24, Patient #5’s post treatment weight was 106.1 kg, or 2.1 kg above the target weight. The records did not show how the abnormal findings were addressed. 8. During interview on 10/1/24 at 4:30 PM, the facility administrator (FA) verified the post treatment weights were above the target weights for Patient #1, Patient #3, and Patient #5, as documented above. The FA also verified the lack of documentation to show if the abnormal findings were addressed. 9. During interview on 10/2/24 at 12:15 PM, the Medical Director (MD) stated expectations for staff to address abnormal findings and to reflect interventions in the patients’ medical records.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 36083 Based on review of medical records and facility policy, staff interviews, and observations, the facility did not implement interventions to manage anemia for 1 of 2 patients (Patient #6) observed for medication administration practices, and for 2 of 5 patients (Patient #2, Patient #5) in the sample for medical records review. The facility reported a census of 32 patients at the time of the survey. Findings include: 1. The policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” dated October 2024, provides that the interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment documenting his/her needs. The policy indicates that the IDT will implement individualized plan of care, specifying necessary services to address the patient’s needs. The facility also indicates that the plan of care will address anemia with “the necessary care and services to achieve and sustain the clinically appropriate hemoglobin level.” 2. During observation on 9/30/24 at 2:05 PM, registered nurse (RN) F stated she was not going to give Patient #3’s Mircera (anemia medicine) 50 microgram even though it was due, because the medication was out of stock. 3. The Patient Summary Report for Patient #3, showed an order on 9/19/24 for Mircera 50 micrograms (mcg) IV (intravenous) every 2 weeks, and the noted that the medication was not yet given. The Patient Treatment Details on 9/30/24, showed that Patient #3 has not received Mircera 50 mcg. 4. During interview on 10/1/24 at 4:30 PM, the facility administrator (FA) stated a change in dosage of Mircera (either increased or decreased) will be given when due, counted back from the last dose of any Mircera given. On 10/2/24 at 12:02 PM, the FA stated Patient #3’s last dose of Mircera was “every 4 weeks” and the last dose was administered on 8/22/24. The FA acknowledged Patient #3 should have received another dose 4 weeks after 8/22/24 or on 9/23/24. The FA, RN C, and the medical director (MD), all verified Patient #3 did not receive the ordered medication (Mircera 50 mcg) since it was due on 9/23/24. 5. Patient #2’s Treatment Details Report showed Patient #2’s last dose of Mircera 30 mcg was administered on 9/16/24. The Patient Summary Report for Patient #2 showed an order dated 9/21/24 for an increased dose of Mircera 50 mcg IV every 2 weeks. The Treatment Details Report dated 9/30/24 (2 weeks from last dose of Mircera on 9/16/24), showed that Patient #2’s Mircera was not given with reason “Not in Stock” noted. 6. During interview on 10/2/24 at 8:30 AM, RN C stated the facility had been out of stock for Mircera 50 mcg for 1 week and that they did not give any to patients with orders for the medication. During interview on 10/2/24 at 12:02 PM, the FA stated the facility will give the Mircera 50 mcg medications soon as they arrive but that they did not know when the stocks will arrive. 7. The Patient Summary Report for Patient #5 showed an order dated 9/29/24 for Mircera 30 mcg every 2 weeks. However, the Treatment Details Report dated 9/30/24 showed Mircera 30 mcg was not given with a reason noted that the medication was not in stock. 8. During interview on 10/2/24 at 12:15 PM, the MD stated that medications such as Mircera should be given according to protocol orders. The MD indicated for initial Mircera orders, it should be started as soon as ordered, and for changes in orders (increased or decreased doses), the changed dose will take effect depending on when the last dose was given. The MD acknowledged facility’s failure to administer the anemia medications as ordered, and further stated expectation that staff members should notify him when ordered medications were not administered due to unavailability.”