Four Seasons Dialysis Center LLC.

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 28297 Based on observation, interview, and review of facility policy, the facility failed to ensure staff wore Personal protective equipment (PPE) appropriate for one of three survey days. The failure to wear PPE appropriately had the potential for staff to be exposed to Bloodborne Pathogens (infectious microorganisms in human blood that can cause disease in humans.) and this could affect 171 in-center patients. Findings include: 1. Observation on 05/21/24 at 1:10 AM revealed Certified Clinical Hemodialysis Technician (CCHT) 32 discontinuing the treatment at Station 3 for Patient (P) 16 via a fistula (a connection between an artery to a vein in to allow for hemodialysis). CCHT32 only had one button on the protective gown buttoned throughout the process. During an interview on 05/21/24 at 1:20 PM, CCHT32 confirmed that his/her gown was not buttoned and was required to be completely closed to prevent exposure to blood. 2. During an observation on 05/21/24 at 2:00 PM, Registered Nurse (RN) 18 was at Station 5 administering medication into the extracorporeal circuit for P17. During an interview on 05/21/24 at 2:05 PM, RN18 confirmed he/she did not have all the buttons on his/her gown buttoned as required but should have to prevent cross contamination of blood. During an interview on 05/21/24 at 3:40 PM the Nurse Manager confirmed staff were required to wear PPE gown completely buttoned to prevent exposure to Bloodborne pathogens. Review of the facility policy titled, “Method of Compliance: Protective Equipment,” effective 07/2004, indicated, “ ...Disposable, impervious gowns will be worn over scrubs when in the treatment area and must be closed in front ...Gowns must fully cover the arms and torso from the neck area to the thigh and knee area ...””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 22676 Based on review of glucometer logs, interview, facility policy review, and review of manufacturer’s instructions, the facility failed to ensure the glucometers were in the control range and follow manufacturer’s instructions for one of one glucometer used in the facility. This had the potential to provide inaccurate glucose results that could result in mistreated blood glucose levels to all 178 patients receiving care at the facility. Findings include: Review of “Blood Glucose Logs” provided by the Administrator, for glucometer (No identify meter number) from 03/01/24 through 05/19/24 revealed the acceptable high blood glucose control range should be 255-388. On 03/06/24 the recorded high control results were 404. During an interview on 05/21/24 at 2:30 PM, the Nurse Manager confirmed the staff did not repeat calibration of the abnormal high testing level. Review of the facility’s policy titled, “Maintaining Glucometer/Supplies,” indicated, “If test results fall outside of the range ...repeat the test.” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/2020, indicated, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 28297 Based on observation, interview, and review of facility policy the facility failed to ensure patient access sites were visible at all times for one of three survey days. The failure to ensure patient access sites were uncovered had the potential for unidentified bleeding and blood loss that could affect 171 in center patients. Findings include: Observation on 05/20/24 at 12:20 PM revealed P13’s left upper arm access site at Station 6 was covered by a blanket. Observation on 05/20/23 at 12:35 PM revealed Certified Clinical Hemodialysis Technician (CCHT) 23 went to Station 6 to do a 30-minute assessment. CCHT23 did not pull back the blanket or uncover the access site as required. Observation on 05/20/24 at 12:50 PM revealed Registered Nurse (RN) 13 went to Station 6 to discontinue the treatment. During an interview on 05/20/24 at 12:50 PM, RN13 confirmed the patient’s access site was covered with the blanket tucked under the patients’ arm. RN13 confirmed the patients access site should be uncovered at all times. During an interview on 05/20/24 at 12:55 PM, CCHT23 stated he/she didn’t realize the patients access site was covered when he/she completed the 30-minute check as required. CCHT23 confirmed he/she should have pulled the blanket back to ensure the access site was uncovered to prevent unidentified bleeding at the access site. Review of the facility’s policy titled, “Prevention of Accidental Access Removal,” effective 01/2010, indicated, “ ...Ensure that access is visible at all times. DO NOT COVER IT UP ...””

“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: 22676 Based on record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for three of 15 sampled in-center patients (Patient (P) 1, P7, and P13). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the all 171 patients receiving in-center dialysis treatments at this facility. Findings include: 1.Review of P1’s electronic medical record (EMR) from 05/08/24 through 05/20/24, revealed a prescribed blood flow rate (BFR) 350 milliliters per min (ml/min). On 05/10/24. The BFR was documented at 400 ml/min from 10:31 AM through 1:43 PM. On 05/13/24, the BFR was documented at 400 ml/min from 10:31 AM though 1:52 PM. On 05/20/24, the BFR was documented at 400 ml/min from 10:01 AM though 1:01 PM. There was no documented rationale for the change to the prescribed BFR. 2. Review of P7’s EMR form 03/05/24 through 05/16/24 revealed a prescribed BFR of 400 ml/min. On 03/05/24, the BFR was documented at 350 ml/min from 2:01 PM though 5:31 PM. There was no documented rationale for the change to the prescribed BFR. 3. Review of P13’s EMR from 05/03/24 through 05/15/24 revealed a prescribed BFR of 400 ml/min. On 05/13/24, the BFR was documented at 450 ml/min from 10:00 AM though 12:30 PM. There was no documented rationale for the change to the prescribed BFR. During an interview on 05/22/24 at 10:00 AM, the Nurse Manager confirmed the above findings and confirmed that staff did not follow the facility’s policy. Review of the facility’s policy titled, “Intradialytic Monitoring” dated 01/2010, indicated, “Prescribed blood flow is maintained unless an event occurs due to treatment thereby maintaining blood flow is not possible ...document the reason and notify the “MD.””