Davita Port Charlotte Artificial Kidney Center

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 21187 Based on review of clinic records, review of facility policies and procedures, and staff interview the facility staff failed to follow the patient plan of care in regard to managing volume status for 13 (Patients #11, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24) of 69 patients reviewed by failing to follow the physician’s order for a Maximum ultrafiltration (UF) rate of 13 milliliters per kilogram per hour (ml/kg/hr). Review of 5 cardiac related deaths at the facility in the last 6 months showed 2 (Patients #25 and 26) of the 5 residents had exceeded 13 ml/kg/hr UF rate in their last two months of dialysis treatments. The physician order for the 15 reviewed patients states: “Maximum Ultra Filtration (UF) Rate 13.0 ml/kg/hr”. The facility staff failed to monitor the fluid removal flow rate resulting in 15 patients exceeding the maximum rate. The facility staff failed to appropriately set the dialysis machine parameters to prevent the UF rate from exceeding the prescribed maximum. The failure to follow the physician’s order of a maximum ultrafiltration rate of 13 ml/kg/hr has a potential to cause serious injury, impairment, or death of patients, and resulted in the determination of the Condition for Coverage noncompliance at Immediate Jeopardy. From 2/29/24 through 3/2/24 ten of twelve staff members; four Registered Nurses (RN), one Licensed Practical Nurse (LPN), and five Patient Care Technicians (CCHT) received training in the following: Ultrafiltration Rate (UFR) Homeroom Lesson #1 Procedure 1-03-08B Fluid Removal Calculations Procedure 1-03-08C Fluid Replacement Calculations UF Calculator (desktop) Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment Understanding UFR in CWOW - Job Aid This includes being educated in the procedure for setting the dialysis machine to remove no more than 13 ml/kg/hr unless otherwise ordered by the physician when starting a dialysis treatment. The remaining two staff members will receive in-service training upon their return to work at the facility. On 3/2/24 at 12:00 p.m. observed patient setup for dialysis treatment. The nurses performed manual calculation for UF rate and applied the settings to the dialysis machines. An RN and a CCHT demonstrated knowledge of the procedure for monitoring post-treatment, the data collected/recorded during treatment and reporting abnormal findings. Cross reference to V0543”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 21187 Based on review of clinic records, review of facility policies and procedures, and staff interview the Governing Body failed to operate the facility in a manner to protect the safety of patients and failed to provide training to staff to ensure physician orders were followed. In March 2023 a software interface program with the dialysis machines for data management was implemented in the facility. The management failed to monitor reports showing outliers in fluid removal flow rates. When a problem with the program-based fluid removal flow rate (ultrafiltration, UF rate) calculation was identified in January 2024 by the software engineers, the Governing Body did not investigate the issue, did not notify the facility staff of a problem, did not modify the procedure for calculating the UF rate, and did not train staff to make adjustments to the dialysis machine settings. The failure of the governing body to ensure staff follow the physician order of a maximum ultrafiltration rate of 13 milliliters per kilogram per hour (ml/kg/hr) has a potential to cause serious injury, impairment, or death of patients, and resulted in the determination of Immediate Jeopardy. The Governing Body implemented the teammate training for the management of the ultrafiltration fluid removal rate to maintain the euvolemic status of patients while on dialysis. From 2/29/24 through 3/2/24 ten of twelve staff members; four Registered Nurses (RN), one Licensed Practical Nurse (LPN), and five Patient Care Technicians (CCHT) received training in the following: Ultrafiltration Rate (UFR) Homeroom Lesson #1 Procedure 1-03-08B Fluid Removal Calculations Procedure 1-03-08C Fluid Replacement Calculations UF Calculator (desktop) Policy 1-03-08 Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment Understanding UFR in CWOW - Job Aid This includes being educated in the procedure for setting the dialysis machine to remove no more than 13 ml/kg/hr unless otherwise ordered by the physician when starting a dialysis treatment. The remaining two staff members will receive in-service training upon their return to work at the facility. On 3/2/24 at 12:00 p.m. observed patient setup for dialysis treatment. The nurses performed manual calculation for UF rate and applied the settings to the dialysis machines. An RN and a CCHT demonstrated knowledge of the procedure for monitoring post-treatment, the data collected/recorded during treatment and reporting abnormal findings. Cross reference to V0751”

“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: 30599 Based on interview, review of clinical records, and facility policy the facility failed to manage the patient’s volume status by failing to follow the physician’s order not to exceed a maximum ultrafiltration (UF) (fluid removal) rate of 13 milliliters per kilogram per hour (ml/kg/hr) for 13 (Patients #11, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24) of 69 patients reviewed. Of the sampled patients, 2 (Patients #11 and 13) have been designated as ‘unstable’ due to concurrent conditions. Review of cardiac deaths in the facility found 2 (Patients #25 and 26) of the 5 cardiac deaths were noted to have exceeded the maximum 13 ml/kg/hr fluid removal rate during the last two months of their treatments. Excessive fluid removal rates can cause heart damage, Myocardial Infarction and Cerebral Vascular Accidents leading to death. This has the potential to affect all facility patients with high UF rate settings; that is, greater than 10 ml/kg/hr using the computer-generated calculations. The findings include: Procedure 1-03-08B reads “Fluid Removal Calculations” 1. Determine the patient’s ultrafiltration rate by subtracting the target weight from the pretreatment weight. Convert to fluid equivalents. 2. Add the total amount of fluids to be received (e.g. Prime, rinse back, oral fluids and IV medications) to the fluid weight removal goal to determine the total amount of fluid to be removed during the dialysis treatment. 3. For Volumetric Controlled fluid removal dialysis delivery systems: Program the amount of fluid to be removed and the treatment length into the UF (ultrafiltration) controlled calculator.” A study by the National Institutes of Health (NHI) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3091945/ and CMS indicate, “Removal of too much fluid or removing it too fast in one dialysis treatment ... may cause hypotension, muscle cramping, and clotting of the vascular access ...The ultrafiltration component of the hemodialysis prescription should be optimized with a goal to render the patient euvolemic and normotensive.” Ultrafiltration rates greater than or equal to 13 ml/kg/hr are associated with increased mortality rates. Record review of the “Treatment Details Report” for Patient #11 and Patient #13 showed: On 2/24/24 Patient #11 exceeded the maximum UF rate at 13.6 ml/kg/hr. On 1/2/24 at 11:45 a.m., Patient #13 exceeded the maximum UF rate at 14 ml/kg/hr. On 1/27/24 Patient #13 had exceeded the maximum UF rate at 15.1 ml/kg/hr. Review of the “Fluid Management Report” from 2/8/24 to 2/22/24 showed: On 2/10/24 Patient #14’s actual fluid removal rate during treatment was 13.6 ml/kg/hr. On 2/13/24 Patient #15’s actual fluid removal rate during treatment was 14 ml/kg/hr. On 2/14/24 Patient #16’s actual fluid removal rate during treatment was 14.7 ml/kg/hr. On 2/8/24 Patient #17’s actual fluid removal rate during treatment was 13. ml/kg/hr. On 2/10/24 Patient #18’s actual fluid removal rate during treatment was 14.4 ml/kg/hr. On 2/20/24 Patient #19’s actual fluid removal rate during treatment was 13.2 ml/kg/hr. On 2/12/24 Patient #20’s actual fluid removal rate during treatment was 14.2 ml/kg/hr. On 2/9/24 Patient #21’s actual fluid removal rate during treatment was 15.6 ml/kg/hr. On 2/14/24 Patient #21’s actual fluid removal rate during treatment was 16.5 ml/kg/hr. On 2/17/24 Patient #21’s actual fluid removal rate during treatment was 13.8 ml/kg/hr. On 2/8/24 Patient #22’s actual fluid removal rate during treatment was 13.2 ml/kg/hr. On 2/13/24 Patient #22’s actual fluid removal rate during treatment was 13.7 ml/kg/hr. On 2/15/24 Patient #22’s actual fluid removal rate during treatment was 13.2 ml/kg/hr. On 2/21/24 Patient #22’s actual fluid removal rate during treatment was 13.6 ml/kg/hr. On 2/12/24 Patient #23’s actual fluid removal rate during treatment was 16.8 ml/kg/hr. On 2/21/24 Patient #23’s actual fluid removal rate during treatment was 14 ml/kg/hr. On 2/14/24 Patient #24’s actual fluid removal rate during treatment was 14.7 ml/kg/hr. For the two patients identified on the Cardiac Death Record: On 4/1/23 Patient #25 had a fluid removal rate during treatment of 14.5 ml/kg/hr. On 4/13/23 Patient #26 had a fluid removal rate during treatment of 13.7 ml/kg/hr. On 2/29/24 at 12:44 p.m., the Facility Administrator (FA) stated she was not aware of an issue with the dialysis machines removing fluids at a rate greater than 13 ml/kg/hr until it was pointed out by the surveyors. The FA stated she has no recollection of a conversation about requiring the facility staff to perform manual calculation of fluid removal rates. She said the facility staff have not received training on how to calculate and input the fluid removal rate manually. The FA verified there were no physician orders to exceed a UF rate of 13 ml/kg/hr during treatment for any of the patients reviewed. The FA confirmed that 13 patients in the past two months experienced UF rates greater than the ordered maximum of 13.0 ml/kg/hr. The FA said the staff do not review the actual rate of fluid removal at the end of a patient’s dialysis session. On 2/29/24 at 3:00 p.m., the Regional Director of Clinical Services (DCS) said the cloud-based technology patient data platform (CWOW) software interface with the dialysis machines was implemented in March 2023. The DCS said that approximately two months ago, early January of 2024, regional management had a telephone conference with the CWOW technicians who developed the software interface for the dialysis machines. The DCS said the technicians detected that some patients were found to be exceeding 13 ml/kg/hr UF rate during their treatments. The DCS stated she did not understand the communications from the technicians at the time, but she had verbally told her FAs over the phone to start doing manual calculations in the machines to ensure none of the patients were exceeding the ml/kg/hr maximum UF rate. The DCS said the CWOW program, in calculating the amount of fluid to be removed from the patient, has a defect in that it does not include the fluids added to the patient during treatment from backwash and rinse that must then be removed. This defect has caused and has the potential to cause any patient with a fluid removal rate setting greater than 10 ml/kg/hr to have an actual rate during the treatment that exceeds the maximum of 13 ml/kg/hr. On 2/29/24 at 3:34 p.m. in a phone interview, the Medical Director said any patient exceeding a 13 ml/kg/hr UF rate on a dialysis machine has an increased risk of cardiac modalities due to stress on the heart including hypotension, Cerebral Vascular Accidents, and Myocardial Infarction. The Medical Director said overtime the stress causes Congestive Heart Failure, and Hypertrophy of the heart. On 2/29/24 at approximately 4:00 p.m., Registered Nurse (RN) Staff A said she determines the estimated fluid removal by entering the post weight of the last treatment and the pre-weight of the patient into the CWOW program for calculation. She would then set the dialysis machine using the calculation. Staff A said she is aware patients are not to exceed 13 ml/per kilogram per hour of fluid removal without a physician’s order. RN Staff A said she started working at the facility around the same time the CWOW system was installed. She said they were taught to trust the automated system in calculating the fluid removal of the dialysis patients. She stated she would verify the estimated fluid removal of the patient and ensure it was below 13 ml per hour prior to the start of the treatment. RN Staff A stated she was not able to see on her displays the actual fluid removal at the end of the treatment. She said she could see the Ultra-filtration on the screen, but she was never taught to verify the patient was not exceeding the ultrafiltration rate during the dialysis treatment.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 30599 Based on interview, record review, and policy and procedure review the Governing body failed to enforce regulations to safeguard the health and safety of 15 (Patients #11, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26) of 69 patients reviewed. The Governing Body failed to ensure the facility staff properly managed the patients’ volume status. The Governing Body failed to act when it was determined the cloud-based technology patient data platform (CWOW) software interface to the dialysis machines was improperly calculating the fluid removal flow rate; that is, the ultrafiltration (UF) rate, for the patients. The 15 patients had dialysis treatments with UF rates exceeding the physician ordered maximum UF rate of 13.0 milliliters/kilogram of body weight/hour (ml/kg/hr). Excessive fluid removal rates can cause heart damage, Myocardial Infarction and Cerebral Vascular Accidents leading to death. This has the potential to affect all facility patients with high UF rate settings; that is, greater than 10 ml/kg/hr using the computer-generated calculations. The findings include: A study by the National Institutes of Health (NHI) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3091945/ and CMS indicate, “Removal of too much fluid or removing it to fast in one dialysis treatment ...may cause hypotension, muscle cramping, and clotting of the vascular access ...The ultrafiltration component of the hemodialysis prescription should be optimized with a goal to render the patient euvolemic and normotensive.” Ultrafiltration rates greater than or equal to 13 ml/kg/ are associated with increased mortality rates. Record review of the “Treatment Details Report” for Patient #11 and Patient #13 showed: On 2/24/24 Patient #11 exceeded the maximum UF rate at 13.6 ml/kg/hr. On 1/2/24 at 11:45 a.m., Patient #13 exceeded the maximum UF rate at 14 ml/kg/hr. On 1/27/24 Patient #13 had exceeded the maximum UF rate at 15.1 ml/kg/hr. Review of the “Fluid Management Report” from 2/8/24 to 2/22/24 showed: On 2/10/24 Patient #14’s actual fluid removal rate during treatment was 13.6 ml/kg/hr. On 2/13/24 Patient #15’s actual fluid removal rate during treatment was 14 ml/kg/hr. On 2/14/24 Patient #16’s actual fluid removal rate during treatment was 14.7 ml/kg/hr. On 2/8/24 Patient #17’s actual fluid removal rate during treatment was 13. ml/kg/hr. On 2/10/24 Patient #18’s actual fluid removal rate during treatment was 14.4 ml/kg/hr. On 2/20/24 Patient #19’s actual fluid removal rate during treatment was 13.2 ml/kg/hr. On 2/12/24 Patient #20’s actual fluid removal rate during treatment was 14.2 ml/kg/hr. On 2/9/24 Patient #21’s actual fluid removal rate during treatment was 15.6 ml/kg/hr. On 2/14/24 Patient #21’s actual fluid removal rate during treatment was 16.5 ml/kg/hr. On 2/17/24 Patient #21’s actual fluid removal rate during treatment was 13.8 ml/kg/hr. On 2/8/24 Patient #22’s actual fluid removal rate during treatment was 13.2 ml/kg/hr. On 2/13/24 Patient #22’s actual fluid removal rate during treatment was 13.7 ml/kg/hr. On 2/15/24 Patient #22’s actual fluid removal rate during treatment was 13.2 ml/kg/hr. On 2/21/24 Patient #22’s actual fluid removal rate during treatment was 13.6 ml/kg/hr. On 2/12/24 Patient #23’s actual fluid removal rate during treatment was 16.8 ml/kg/hr. On 2/21/24 Patient #23’s actual fluid removal rate during treatment was 14 ml/kg/hr. On 2/14/24 Patient #24’s actual fluid removal rate during treatment was 14.7 ml/kg/hr. For the two patients identified on the Cardiac Death Record: On 4/1/23 Patient #25 had a fluid removal rate during treatment of 14.5 ML/KG/HR. On 4/13/23 Patient #26 had a fluid removal rate during treatment of 13.7 ML/KG/HR. On 2/29/24 at 12:44 p.m., the Facility Administrator (FA) stated she was not aware of an issue with the dialysis machines removing fluids at a rate greater than 13 ml/kg/hr until it was pointed out by the surveyors. The FA said when the cloud-based patient data interface system was implemented in March of 2023, they were told to trust the system to calculate the required ultrafiltration rate. The FA stated she has no recollection of a conversation about requiring the facility staff to perform manual calculation of fluid removal rates. She said the facility staff have not received training on how to calculate and input the fluid removal rate manually. The FA verified there were no physician orders to exceed a UF rate of 13 ml/kg/hr during their treatments for any of the patients reviewed. The FA confirmed that 13 patients in the past two months experienced UF rates greater than the ordered maximum of 13.0 ml/kg/hr. The FA said the staff do not review the actual rate of fluid removal at the end of a patient’s dialysis session. The FA verified the facility does not have a current policy or procedure for monitoring UV rates. On 2/29/24 at 1:30 p.m., the Medical Director said he was not aware of the issue of patients exceeding the maximum ultrafiltration rate until now. The Medical Director stated nurses should never exceed 13 ML/KG/HR without a written physician’s order. They were going to have to check into the issue to prevent it from reoccurring. On 2/29/24 at 3:00 p.m., the Regional Director of Clinical Services (DCS) said the cloud-based technology patient data platform (CWOW) software interface with the dialysis machines was implemented in March 2023. The DCS said that approximately two months ago, early January of 2024, regional management had a telephone conference with the CWOW technicians who developed the software interface for the dialysis machines. The DCS said the technicians detected that some patients were found to be exceeding 13 ml/kg/hr UF rate during their treatments. The DCS stated she did not understand the communications from the technicians at the time, but she had verbally told her FAs over the phone to start doing manual calculations in the machines to ensure none of the patients were exceeding the ml/kg/hr maximum UF rate. The DCS said the CWOW program, in calculating the amount of fluid to be removed from the patient, has a defect in that it does not include the fluids added to the patient during treatment from backwash and rinse that must then be removed. This defect has caused and has the potential to cause any patient with a fluid removal rate setting greater than 10 ml/kg/hr to have an actual rate during the treatment that exceeds the maximum of 13 ml/kg/hr. The DCS said a report is produced by the CWOW system that charts the fluid removal rate for each dialysis session performed company wide. She said the reports had not been monitored and the fluid removal rate greater than 13 ml/kg/hr was missed. The DCS said there is no documentation that management investigated the extent or outcomes of exceeding the maximum UF rate of 13 ml/kg/hr. She stated she was going to look for some notes she might have taken in January of this year regarding what she learned and what actions were taken. The DCS provided no documentation of any action taken by the company to prevent patients from exceeding a maximum ultrafiltration rate of 13 ml/kg/hr in response to learning of the issue. The DCS was not able to produce documentation that the facilities were informed about the fluid removal rate ‘glitch’. No written procedure was implemented for staff to manually set the fluid removal rate and no training was provided to the staff in the facilities. On 2/29/24 at 3:34 p.m. in a phone interview, the Medical Director said any patient exceeding a 13 ml/kg/hr UF rate on a dialysis machine has an increased risk of cardiac modalities due to stress on the heart including hypotension, Cerebral Vascular Accidents, and Myocardial Infarction. The Medical Director said overtime the stress causes Congestive Heart Failure, and Hypertrophy of the heart.”