Fresenius Kidney Care Fitchburg

“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 141 in-center patients. Findings include: Observation on 12/04/24 at 2:25 PM Patient Care Technician (PCT) 1 was at Station 19 flushing the venous port line and changing the venous transducer where blood had backed up into the venous port line and venous transducer. PCT1 did not have on a gown or eye protection. Observation on 12/04/24 at 2:30 PM PCT1 was at Station 18 flushing the venous port line with normal saline and changing the venous transducer where blood had backed up into the venous port line and venous transducer. PCT1 did not have on a gown or eye protection. During an interview on 12/04/24 at 2:30 PM PCT 1 confirmed he/she did not have on a gown or eye protection when flushing the venous port line with normal saline and changing the venous transducer at Station 18 and 19 however it was required since there was a risk for blood spatter when flushing the venous port line and changing the venous transducer. During an interview on 12/06/24 at 2:15 PM the Charge Nurse stated it was concerning that a staff member would not wear appropriate PPE in situations that are high risk for blood spatter such as flushing the venous port line with saline and changing the venous transducer. The Charge Nurse confirmed blood could have splatter out of the venous line and exposed the staff to bloodborne pathogens. During an interview on 12/06/24 at 3:45 PM the Administrator confirmed staff should have had on appropriate PPE including a gown and eye protection when flushing the venous port line and changing the transducer as there is a high risk for blood splatter during this process. 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 ...” Review of the facility policy titled, “Exposure Categories and Determination,” revised 07/01/24, indicated, “ ...Job Classifications that involve exposure or reasonably anticipated exposure to blood or other potentially infections material or that involve likelihood for spills or splashes of blood or other potentially infectious material ...Handling infected material requires gloves, full face shield or mask and goggles and gown ...””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 28297 Based on observation, interview, and review of facility documents and policy, the facility failed to maintain the patient in-center dialysis treatment chairs in good condition. Failure to maintain 14 of 39 treatment chairs had the potential to negatively impact infection control practices to all 141 in-center hemodialysis patients. Findings include: During an observation on 12/05/24 at 3:40 PM, revealed 14 dialysis stations each with a reclining treatment chair for patient use. Observation of Station 1, 2, 3, 4, 5, 6, 7, 9, 11, 15, 17, 24, 26, and 29 revealed the dialysis station chairs’ seat cushions, headrest covers and/or footrests had cracks, rips, tears, peeling vinyl, visible signs of wear, or were torn. During an interview on 12/05/24 at 3:40 PM, the Area Technical Operations Director (ATOM) confirmed he/she was aware of the dialysis chair issues and verified the dialysis chairs could not effectively be cleaned to prevent infection control concerns. During an interview on 12/06/24 at 1:40 PM, the Director of Operations (DOR) confirmed he/she was aware of the dialysis chair issues and verified the dialysis chairs could not effectively be cleaned to prevent infection control concerns. The DOR also stated the clinic did not have a specific policy related to the cleaning/disinfecting of the dialysis chairs.”

“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: 36461 Based on record review, interview, and review of the facility’s policy, the facility failed to follow the hemodialysis prescription order for the blood flow rate (BFR) and/or dialysis flow rate (DFR) for four of 15 in-center hemodialysis patients (Patient (P)5, P6, P7, and P9) sampled. Failure to follow the physician orders had the potential for inadequate dialysis treatments. The failed practice had the potential to affect the 141 in-center hemodialysis patients. Findings include: 1. Medical record review for P5 revealed a “Patient Transfer,” record with hemodialysis orders dated 11/26/24, for a BFR of 450 milliliters per minute (mL/min) and DFR of autoflow of 1.5 (650 mL/min). Review of six “Hemodialysis Treatment Flowsheets,” for P5, dated 11/23/24 through 12/03/24, revealed the following: On 11/23/24 - Treatment was initiated at 11:31 AM with a BFR at 400 mL/min and DFR at 600 ml/mL/min ran until the treatment ended at 2:58 PM with no documented rationale for the changes. On 11/25/24 - Treatment was initiated at 12:25 PM with a BFR at 400 mL/min and DFR at 600 mL/min ran until the treatment ended at 3:26 PM with no documented rationale for the changes. On 11/27/24 - Treatment was initiated at 12:01 PM with a BFR at 400 mL/min and DFR at 600 mL/min ran until the treatment ended at 2:58 PM with no documented rationale for the changes. 2. Medical record review for P6 revealed a “Patient Transfer,” record with hemodialysis orders dated 11/05/24, for a BFR of 450 mL/min and DFR of 800 mL/min. Review of six “Hemodialysis Treatment Flowsheets,” for P6, dated 11/21/24 through 11/27/24, revealed the following: On 11/23/24 - Treatment was initiated at 11:19 AM with a BFR at 400 mL/min and DFR at 600 mL/min ran until the treatment ended at 2:05 PM with no documented rationale for the changes. 3. Medical record review for P7 revealed a “Patient Transfer,” record with hemodialysis orders dated 11/11/24, for a BFR of 450 mL/min and DFR of autoflow 1.5 (600 mL/min). Review of six “Hemodialysis Treatment Flowsheets,” for P7, dated 11/20/24 through 12/02/24, revealed the following: On 11/20/24- Treatment was initiated at 1:38 PM with a BFR at 400 mL/min and DFR at 600 mL/min, changed at 2:33 PM to a BFR at 350 mL/min and DFR 600 mL/min, changed at 3:34 PM to a BFR at 300 mL/min and DFR at 500 mL/min and ran at that rate until the treatment ended at 5:04 PM with no documented rationale for the changes. On 11/22/24 - Treatment was initiated at 1:08 PM with a BFR at 450 mL/min and DFR at 200 mL/min, changed at 1:32 PM to a BFR at 350 mL/min and DFR at 600 mL/min, changed at 3:30 PM to BFR at 400 mL/min and DFR at 600 mL/min and ran until the treatment ended at 4:42 PM with no documented rationale for the changes. On 11/24/24 - Treatment was initiated at 1:33 PM with a BFR at 450 mL/min and DFR at 700 mL/min, changed at 2:07 PM to a BFR at 400 mL/min and DFR at 600 mL/min, and ran until the treatment ended at 4:34 PM with no documented rationale for the changes. On 11/26/24 - Treatment was initiated at 1:10 PM with a BFR at 300 mL/min and DFR at 500 mL/min, changed at 2:32 PM to a BFR at 350 mL/min and DFR at 600 mL/min, and ran until the treatment ended at 4:38 PM with no documented rationale for the changes. On 11/29/24 - Treatment was initiated at 1:33 PM with a BFR at 400 mL/min and DFR at 600 mL/min, changed at 2:32 PM to a BFR at 350 mL/min and DFR at 600 mL/min, changed at 3:40 PM to a BFR at 300 mL/min and DFR at 500 mL/min and ran until the treatment ended at 4:33 PM with no documented rationale for the changes. On 12/02/24 - Treatment was initiated at 1:13 PM with a BFR at 400 mL/min and DFR at 600 mL/min, changed at 4:02 PM to a BFR at 300 mL/min and DFR at 500 mL/min, and ran until the treatment ended at 4:43 PM with no documented rationale for the changes. 4. Medical record review for P9 revealed a “Patient Transfer,” record with hemodialysis orders dated 11/11/24, for a BFR of 450 mL/min and DFR of autoflow 1.5 (600 mL/min). Review of six “Hemodialysis Treatment Flowsheets,” for P9, dated 11/20/24 through 12/02/24, revealed the following: On 11/22/24 - Treatment was initiated at 2:14 PM with a BFR at 400 mL/min and DFR at 600 mL/min, changed at 2:33 PM to a BFR at 450 mL/min and DFR 700 mL/min, changed at 3:02 PM to a BFR at 400 mL/min and DFR at 600 mL/min, changed at 5:33 PM to a BFR at 350 mL/min and DFR at 800 mL/min and ran at that rate until the treatment ended at 5:56 PM with no documented rationale for the changes. On 11/24/24 - Treatment was initiated at 2:01 PM with a BFR at 400 mL/min and DFR at 200 mL/min, changed at 2:34 PM to a BFR at 400 mL/min and DFR 600 mL/min, and ran at that rate until the treatment ended at 6:00 PM with no documented rationale for the changes. On 11/29/24 - Treatment was initiated at 2:32 PM with a BFR at 300 mL/min and DFR at 500 mL/min, changed at 3:00 PM to a BFR at 400 mL/min and DFR 600 mL/min, changed at 4:16 PM to a BFR at 450 mL/min and DFR 700 mL/min, changed at 5:06 PM to a BFR at 400 mL/min and DFR 600 mL/min and ran at that rate until the treatment ended at 6:26 PM with no documented rationale for the changes. During an interview with Patient Care Technician (PCT) 2 on 12/06/24 at 1:15 PM, he/she stated any changes to the dialysis prescription should be documented in the patient’s treatment flowsheet and reported to the nurse. During an interview with Registered Nurse (RN) 1 on 12/06/24 at 11:45 AM, he/she stated any changes to the dialysis prescription must be documented and to notify the nurse. During an interview with Medical Director on 12/06/24 at 3:30 PM, he/she stated the expectation was that any changes, or variances, to the dialysis prescriptions must be documented on the treatment flowsheets and the physician notified if adjustments are made multiple times during a single treatment or over the course of multiple days. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” last revised May 2023, revealed, “ ... 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 dialysate flow rate setting is correct, and the prescribed flow is being delivered ...” and “ ...Document any findings and interventions in the medical record ...””

“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 one of three Peritoneal Dialysis (PD) Patients (Patient (P) 13) was given the opportunity to attend and 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 30 PD patients. Findings include: Review of the “Face Sheet” provided by the facility for P13 revealed the facility admitted the patient on 06/03/24 with a diagnosis of end stage renal disease (ESRD). Review of P13’s annual “POC” provided by the facility, dated 09/12/24, revealed the patient did not sign off on the “POC” to indicate the patient participated in the “POC.” During an interview on 12/05/24 at 12:50 PM the Registered Nurse (RN)1 stated the Clinic Manager was responsible for having patients sign their POC. During an interview on 12/06/24 at 11:00 AM the Peritoneal Dialysis Nurse stated he/she was responsible for having patients sign their POC however he/she acknowledged and confirmed P13 had not signed their POC. Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” revised 07/03/23, revealed, “ ...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 inwriting 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 three of 10 sampled in-center patients (Patients (P)1, P3, and P10) 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 141 in-center hemodialysis patients. Findings include: 1.Review of the medical record “Face Sheet” provided by the facility for P1 revealed the facility admitted the patient on 08/26/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the “Dialysis Flow Records” provided by the facility revealed on 11/16/24 P1’s BP was checked at 1:32 PM with a reading of 105/65. Per facility policy P1’s BP should have been checked no later than 2:13 PM and was not checked until 2:32 PM with a reading of 99/56, which was 20 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 P3 revealed the facility admitted the patient on 06/14/21 with a diagnosis of ESRD. Review of the “Dialysis Flow Records,” provided by the facility, revealed on 11/25/24 P3’s BP was checked at 5:41 AM with a reading of 126/71. Per facility policy P3’s BP should have been checked no later than 6:26 AM and was not checked until 7:02 AM with a reading of 141/74, which was 36 minutes late. P3’s BP was checked again at 7:32 AM with a reading of 114/82 and should have been checked no later than 8:17 AM and was not checked until 9:01 AM with a reading of 110/61, which was 44 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. 3. Review of the medical record “Face Sheet” provided by the facility for P10 revealed the facility admitted the patient on 07/20/21 with a diagnosis of End Stage Renal Disease (ESRD). Review of the “Dialysis Flow Records” provided by the facility revealed on 11/22/24 P0 ‘s BP was checked at 12:33 PM with a reading of 136/83. Per facility policy P10’s BP should have been checked no later than 1:18 PM and was not checked until 1:34 PM with a reading of 129/82 which was 16 minutes late. P10’s blood pressure was checked at 3:02 PM with a reading of 112/75. Per facility policy P10’s blood pressure should have been checked no later than 3:47 PM and was not checked until 4:06 PM with a reading of 102/68, which was 19 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. During an interview on 12/06/24 at 1:10 PM Patient Care Technician (PCT) 2 confirmed there were missing blood pressure checks and monitoring of patients for P1, P3 and P10. 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 12/06/24 at 2:00 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 P1, P3 and P10. RN1 stated the blood pressure tells the condition of the patient and if not monitored there was a risk of hypotension that could result in an adverse event. During an interview on 12/06/24 at 2:15 PM the Charge Nurse confirmed there were missing blood pressure checks on P1, P3 and P10. He/she stated the expectation was that staff were walking around to each station every 30 minutes to check the patient’s blood pressure and assess the patient access site, the patient’s mental status to ensure no change in condition, and to verify the machine was function properly and were the physician orders. The Charge Nurse stated if the patient were not monitored every 30 minutes including blood pressures there was a risk of low blood pressure that could lead to an adverse event such as loss of consciousness or cardiac arrest. The Charge Nurse confirmed the facility policy says the patients must be monitored every 30 minutes and that it was unacceptable that blood pressures were not documented every 30 minutes. During an interview on 12/06/24 at 3:15 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 level of consciousness was assessed. He/she stated fluid was being removed from the patient and that could cause the patient’s blood pressure to drop. The Medical Director stated the patient could be asleep and pass out however that can be assessed by checking the patient’s blood pressure. He/she stated he/she would be very uncomfortable if the patient’s blood pressure was not checked per facility policy of every 30 minutes. 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 ...””