Fresenius Kidney Care Sun Prairie

“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 appropriate Personal Protective Equipment (PPE) (face protection, gloves, fluid resistant/fluid imperious garment used to protect staff from being exposed to Bloodborne Pathogens-infectious microorganisms in human blood that can cause disease in humans) for one of three survey days. The failure to wear PPE appropriately had the potential for staff to be exposure to blood borne pathogens and this could affect 69 in-center patients. Findings include: Observation on 12/10/24 at 10:30 AM Licensed Practical Nurse (LPN) 1 was at Station 7 initiating the dialysis treatment for Patient (P) 8 via fistula (the gold standard vascular access used to access the blood for hemodialysis treatment for those with chronic kidney disease.) LPN 1 did not have on a mask or face covering to protect his/her mouth. During an interview on 12/10/24 at 10:40 AM LPN1 stated that they were told that a mask and goggles were only required for Central Venous Catheters (CVC- a type of central venous access device specifically designed to facilitate kidney replacement therapy in patients without a functioning long-term hemodialysis vascular access) and a mask was not required for care of fistulas. LPN1 acknowledged he/she would be at risk for blood splatter to the nose and mouth without protection. During an interview on 12/11/24 at 2:05 PM the Administrator confirmed staff were required to wear full PPE including gown, gloves, and full-face covering including goggles and a mask covering the nose and mouth or a full-face shield that covered the eyes, nose, and mouth to protect from potential blood splatters during initiation and termination of dialysis via CVC and fistula. Review of the facility policy titled, “Personal Protective Equipment,” revised 11/06/23, indicated, “ ...Personal protective equipment including a full-face shield or mask and protective eyewear with full side shield, fluid resistant gowns, and gloves must be worn to protect employees from blood or other potentially infectious material (OPIM). PPE is used to protect employees who are occupationally exposed to blood or OPIM 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.)””

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, the facility failed to ensure expired medications were disposed of and not available for use during one of three survey days. Failure to remove expired medical supplies had the potential to affect 69 in-center patients receiving dialysis treatments at the facility. Findings include: During an observation of the medication refrigerator on 12/11/24 at 11:40 AM, one vial of Purified Protein Derivative (PPD) testing solution (used to test patients for Tuberculosis, a highly contagious respiratory disease) and a vial of Heparin (medication used as a blood thinner) 30,000 units per 30 milliliters was opened and undated. During an interview on 12/11/24 at 11:45 AM, Registered Nurse (RN) 1 confirmed the medications were opened and undated. RN1 stated monthly audits for expired medications were checked however it was not included on the medication count list. During an interview on 12/11/23 at 11:45 AM, the Administrator stated the medications should be checked monthly and discarded if unlabeled or older than 28 days from opening per facility policy. He/she confirmed staff were required to date and initial multidose vials when opened to ensure they were disposed of within 28 days. Review of the facility policy titles “Medications Preparation and Administration,” revised 02/06/23, indicated “ ...label any open multi-dose vial that is not used immediately and store vial accordingly ...Expiration dates for all stored medications are to be monitored on a monthly basis ...Any open multi dose vials must be discarded 28 days after opening or per manufacture’s expiration date ...””

“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 the facility’s policy and procedure, the facility failed to keep patient hemodialysis access sites uncovered and visible for one of three days of the survey. The needle insertion sites and line connections for all patients on treatment must be visible to staff at all times to ensure the lines and needles do not become dislodged or disconnected that could lead to an adverse event and could affect all 69 in-center patients receiving treatment in the facility. Findings include: Observation on 12/10/24 at 10:10 AM revealed Patient (P) 4 at Station 14 had their access sites covered, with a blanket. Patient Care Technician (PCT) 1 did a check on the patient however he/she did not pull back the blanket to view the access site. During an interview on 12/10/24 at 10:15 AM PCT1 confirmed he/she did not pull back the blanket at Station 14 when he/she did the blood pressure check at 10:10 AM and should have to ensure the access site was stable with no bleeding. Observation on 12/10/24 at 10:25 AM revealed P2 at Station 6 left arm access site was covered by a blanket. Observation on 12/10/24 at 10:50 AM revealed P2 at Station 6 access site remained covered. Licensed Practical Nurse (LPN) 1 did a blood pressure check and machine monitor checked at Station 6 however he/she did not uncover the access site. LPN1 went over to another station to discontinue a dialysis treatment and could not be interviewed at the time of the observation. Observation on 12/10/24 at 11:10 Registered Nurse (RN) 2 completed a blood pressure check and machine monitor check at Station 6 for P2 and uncovered the patient access site. During an interview on 12/11/124 at 1:20 PM RN 1 stated patient access sites should always be visible and if covered when doing the 30-minute checks staff should uncover the access site to ensure there was no bleeding or needle dislodgement. During an interview on 12/11/24 at 2:05 the Administrator stated patient access sites must be always uncovered per facility policy and if the patient refused it must be documented in the patient medical record. Review of the facility policy titled, “Patient Assessment and Monitoring,” revised 05/01/23 indicated, “ ...During Treatment ...Access-Observe connections are secure and visible ...ensure access remains uncovered throughout the treatment. Observe and ensure: Tape is secure, Needles are intact, No bleeding or infiltration is noted ...””

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 28297 Based on interview, record review, and review of facility policy, the facility failed to ensure two of seven sampled in-center patients (Patient (P) 4 and P6) were given the opportunity to participate in their Plan of Care (POC). The failure to give patients opportunities to be involved in their POC had the potential for missed opportunities for improved care and this could affect the 69 in-center patients. Findings include: 1.Review of the “Face Sheet” provided by the facility for P4 revealed the facility admitted the patient on 12/28/23 with a diagnosis of end stage renal disease (ESRD). Review of P4’s initial “POC” provided by the facility, dated 01/23/24, revealed the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” Review of P4’s 90day “POC” provided by the facility, dated 04/23/24, revealed the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” 2. Review of the “Face Sheet” provided by the facility for P6 revealed the facility admitted the patient on 06/04/18 with a diagnosis of ESRD. Review of P6’s annual “POC” provided by the facility, dated 03/09/24, revealed the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” During an interview on 12/11/24 at 12:00 PM the Dietitian stated the Social Worker or Nurse was responsible for getting the patients signature on the “POC” after the meeting had taken place. During an interview on 12/11/24 at 1:00 PM the Social Worker stated the Registered Nurse was responsible for having the patient sign the “POC” after the meeting had taken place. He/she stated it was important to have the patient sign the “POC” to ensure they understand their plan and given an opportunity to ask any questions. During an interview on 12/11/24 at 1:20 PM Registered Nurse (RN) 1 stated he/she was unaware that nurses were responsible to have patients sign their “POC.” During an interview on 12/11/24 at 2:05 PM the Administrator stated the Social Worker was responsible to print out the completed “POC” and given to the nurses on the treatment floor to have them go over it with the patient and get the patients signature to indicate they acknowledged the information in the “POC.” The Administrator confirmed the “POCs” were not signed by P4 and P6 Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” revised 07/03/23, indicated, “ ...Patient Participation in Plan of Care the following are recommendations for involving the patient in the development and review of the Plan of Care: ...Encourage both patient and family to participate in the Plan of Care discussions in whatever format the facility and attending physician develop. Notify the patient in writing of the time and date of the Plan of Care review ...If the patient and or designee is unable or unwilling to attend the Plan of Care meeting ...the Registered Nurse may review the Plan of Care as developed by the IDT at the meeting with the patient and obtain the patients’ signature and any comments. The patients’ level of participation is determined by the patients ...””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 28297 Based on interview, record review, and review of the facility’s policy, the facility failed to ensure two of seven sampled in-center patients (Patients (P)3, and P4) documentation for monitoring was complete. The failure to document monitoring of patients per facility policy had the potential to not capture a potential adverse event in a timely manner and could affect all 69 in-center hemodialysis patients. Findings include: 1.Review of the medical record “Face Sheet” provided by the facility for P3 revealed the facility admitted the patient on 03/28/23 with a diagnosis of End Stage Renal Disease (ESRD). Review of the “Dialysis Flow Records” provided by the facility revealed on 11/27/24, P3’s blood pressure (BP) was checked at 11:40 AM with a reading of 95/71. Per facility policy P3’s BP should have been checked no later than 12:25 PM and was not checked until 12:35 PM with a reading of 94/63, which was 10 minutes late. In addition, staff did not document that the patient’s access site, dialysis prescription, and heparin infusion were monitored by checking the box on the flow sheet as required per facility policy. Review of the “Dialysis Flow Records” provided by the facility revealed on 12/05/24 P3’s BP was checked at 1:03 PM with a reading of 94/61. Per facility policy P3’s BP should have been checked no later than 1:48 PM and was not checked until 2:01 PM with a reading of 93/67, which was 13 minutes late. In addition, staff did not document that the patient’s access site, dialysis prescription, and heparin infusion were monitored by checking the box on the flow sheet as required per facility policy. 2. Review of the medical record “Face Sheet” provided by the facility for P4 revealed the facility admitted the patient on 12/28/23 with a diagnosis of ESRD. Review of the “Dialysis Flow Records,” provided by the facility, revealed on 12/03/24 P4’s BP was checked at 8:35 AM with a reading of 117/61. Per facility policy P4’s BP should have been checked no later than 9:20 AM and was not checked until 9:54 AM with a reading of 161/65, which was 34 minutes late. In addition, staff did not document that the patient’s access site and dialysis prescription were monitored by checking the box on the flow sheet as required per facility policy. Review of the “Dialysis Flow Records,” provided by the facility, revealed on 12/05/24 P4’s BP was checked at 9:31 AM with a reading of 109/61. Per facility policy P4’s BP should have been checked no later than 10:14 AM and was not checked until 10:34 AM with a reading of 115/55, which was 20 minutes late. In addition, staff did not document that the patient’s access site and dialysis prescription were monitored by checking the box on the flow sheet as required per facility policy. During an interview on 12/11/24 at 12:15 PM Patient Care Technician (PCT) 2 confirmed there were missing blood pressure checks and monitoring for P3, and P4. He/she stated the purpose of monitoring patients every 30 minutes was to ensure access sites were uncovered and not bleeding, that the dialysis machine was functioning correctly, and that the patient was safe. PCT2 stated they must monitor the patient’s blood pressure every 30 minutes because if the blood pressure drops it could mean too much fluid was being removed and the patient could become unresponsive. During an interview on 12/11/24 at 1:20 PM Registered Nurse (RN) 1 stated the patient’s blood pressure must be monitored every 30 minutes and if it drops, they may check it as soon as every 15 minutes. RN1 confirmed they are checking more than the patient blood pressure every 30 minutes including the patient access site, the dialysis prescription, and any machine malfunction. RN1 confirmed there were missing blood pressures for P3 and P4. RN1 stated if the patient blood pressure drop they could have an adverse event such as passing out. During an interview on 12/11/24 at 2:05 PM the Administrator confirmed the missing blood pressure and 30 minutes monitoring for P3 and P4. He/she stated it was important to do the checks because patients could become unstable, and they wouldn’t know unless they checked the blood pressure and if caught early enough we can prevent further complications. During an interview on 12/11/24 at 2:30 PM the Medical Director stated the expectation was that staff will do a visual observation of the patient and dialysis machine to ensure the machine was functioning properly and the patient and access was checked. He/she stated it was not good if patients were not monitored every 30 minutes because there could be potential complications such as syncope (loss of consciousness and cardiac arrest. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” revised 05/01/23 indicated, “Purpose: The purpose of this policy is to provide guidance to FKC direct patient care staff on assessment and monitoring patients before, during and after treatment. Direct patient care staff (RN, LPN/LVN, PCT ...) ...During Treatment, obtain blood pressure and pulse rate every 30 minutes or more often but not to exceed 45 minutes or per state regulation. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulation. Follow the steps below for monitoring patient and machine parameters during treatment: Blood pressure-record blood pressure. Recheck blood pressures after a drop that required interventions such as administering normal saline ... Report to the nurse: systolic blood pressure greater than 180mm/hg Diastolic blood pressure greater than 100mm/hg, blood pressure less than or equal to 100mm/hg systolic. Pulse: Record pulse. Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute. Report to the nurse patients whose heart rate has dropped below 60, risen above 100 or become irregular. Respirations: Observe for changes in respirations. Report to the nurse observations or complaints from the patient of shortness of breath, labored or difficult breathing ... Ultrafiltration Rate: Monitor UF rate. Note: Ultrafiltration rates greater than 13ml/kg/hr should be avoided if possible by providing adequate prescribed dialysis duration, and scheduling of additional treatments if medically necessary. Reported by patient: Ask if any new complaints to report. General Observations/Mental Status: Observe the patients’ overall condition during treatment. Report to the nurse any changes in patients’ overall condition or any changes in mental status ...Access: Observe connections are secure and visible ...Observe and ensure: Tape is secure, Needles are intact, No bleeding or infiltration is noted ...Machine Parameters and Extracorporeal Circuit: Check machine settings and measurements. Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow ...Check the amount of fluid removal. If heparin pump is used, ensure heparin is infusing at prescribed rate ...””