Fresenius Medical Care of Hickory

“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: 35306 Based on facility policy review, observations, and staff interview, the facility staff failed to follow infection control standard precautions by failing to ensure faceshields covered the eyes, mouth, and nose during access of an AVF for initiation of dialysis in 1 of 2 observations (Patient #11, CCHT #1) and 1 of 1 blood draw observations (Patient #13, CCHT #1). Findings included: Review on 12/06/2023 of facility policy titled, “Initiation of Treatment Using an Arteriovenous Graft or Fistula and Optiflux Single Use Ebeam Dialyzer,” Published: 07/06/2021, revealed “... The following supplies are needed for this procedure: Personal Protective Equipment (PPE) including gown, gloves, mask, and face shield/goggles...” Review on 12/15/2023 of facility policy titled, “Personal Protective Equipment,” Published: 11/06/2023, revealed “...The purpose of this policy is to identify Personal Protective Equipment (PPE) and potential areas for use... Employees shall use personal protective equipment in accordance with the type of patient contact expected and anticipated exposure... Personal protective equipment including a full-face shield or mask and protective eyewear with full side shield....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...” 1. Observation on 12/06/2023 at 1050 revealed CCHT #1 accessed Patient #11’s AVF for initiation of dialysis with a full-face shield propped on top of her head. Observation revealed CCHT #1 failed to use the facility provided PPE and to follow infection control standard precautions outlined in the facility’s PPE policy. Interview on 12/07/2023 at 1035 with the CM revealed that her expectation would be that “staff members would protect themselves from blood splatter.” Interview on 12/07/2023 at 1110 with the CN revealed, “The face shield should cover the entire face” anytime there is potential for blood splatter. Interview on 12/07/2023 at 1210 with CCHT #1 revealed, “We are supposed to have it [full-face shield] down. I flip it [faceshield] up and forget to flip it [full-face shield] back down.” 2. Observation on 12/06/2023 at 1108 revealed CCHT #1 accessed Patient #13’s AVF for a blood draw with a full-face shield propped on top of her head. Observation revealed CCHT #1 failed to use the facility provided PPE and to follow infection control standard precautions outlined in the facility’s PPE policy. Interview on 12/07/2023 at 1035 with the CM revealed that her expectation would be that “staff members would protect themselves from blood splatter.” Interview on 12/07/2023 at 1110 with the CN revealed, “The face shield should cover the entire face” anytime there is potential for blood splatter. Interview on 12/07/2023 at 1210 with CCHT #1 revealed, “We are supposed to have it [full-face shield] down. I flip it [faceshield] up and forget to flip it [full-face shield] back down.””

“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: 35306 Based on facility policy review, medical record reviews, and staff interview, the facility staff failed to monitor a patient at a minimum of every 30 minutes during hemodialysis treatments for 2 of 10 sampled in-center hemodialysis records reviewed (Patients #2 and #9). Findings included: Review on 12/06/2023 of facility policy titled, “Patient Monitoring and Safety Checks During Hemodialysis Treatment,” Published: 09/05/2023, revealed “... The purpose of this document is to provide guidance for patient monitoring and safety check guidelines during hemodialysis treatments... Monitor and document every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in the [Facility Initials] Treatment Record. Review on 12/06/2023 of the facility policy titled, “Patient Assessment and Monitoring,” Published: 05/01/2023, revealed “... During Treatment ... Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations. 1. Review of the medical record for Patient #2 revealed a 59-year-old male admitted for In-Center Hemodialysis treatments on 12/14/2021. Review of the Treatment Flowsheet for 11/23/2023 revealed staff documented monitoring at 0720 and the next monitoring documentation was at 0818 (57 minutes later). Review of the Treatment Flowsheet for 11/28/2023 revealed staff documented monitoring at 0730 and the next monitoring documentation was at 0833 (63 minutes later). Review of the Treatment Flowsheet for 12/02/2023 revealed staff documented monitoring at 0911 and the next monitoring documentation was at 1019 (68 minutes later). Interview on 12/07/2023 at 1035 with the CM revealed she had reviewed the expectations of monitoring patients and the policy with staff. Interviewed revealed the staff were expected to monitor the patients every 30 minutes during treatments or more frequently as needed, but not to exceed 45 minutes. Interview revealed the staff monitored vital signs, visualized the access sites and checked for wet transducers and machine parameters. Interview revealed the staff failed to document the patient monitoring per policy. Interview on 12/07/2023 at 1110 with the CN revealed patients are to be monitored every 30-45 minutes per policy. Interview revealed delays in documenting monitoring for Patient #2 were likely due to staff having to donn PPE to go into the isolation room to enter data into the electronic health record. Interview revealed the staff failed to document the patient monitoring per policy. 2. Review of the medical record for Patient #9 revealed a 42-year-old male admitted for In-Center Hemodialysis treatments on 05/05/2011. Review of the Treatment Flowsheet for 11/21/2023 revealed staff documented monitoring at 1253 and the next monitoring documentation was at 1350 (57 minutes later). Interview on 12/07/2023 at 1035 with the CM revealed she had reviewed the expectations of monitoring patients and the policy with staff. Interviewed revealed the staff were expected to monitor the patients every 30 minutes during treatments or more frequently as needed, but not to exceed 45 minutes. Interview revealed the staff monitored vital signs, visualized the access sites and checked for wet transducers and machine parameters. Interview revealed the staff failed to document the patient monitoring per policy. Interview on 12/07/2023 at 1110 with the CN revealed patients are to be monitored every 30-45 minutes per policy. Interview revealed delays in documenting monitoring for Patient #2 were likely due to staff having to donn PPE to go into the isolation room to enter data into the electronic health record. Interview revealed the staff failed to document the patient monitoring per policy.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 49480 Based on policy review, medical record review, and staff interview the facility staff failed to follow the adequacy plan of care by failing to dialyze patients at the prescribed BFR in 5 of 10 sampled in-center hemodialysis records reviewed (Patients #1, #4, #2, #6, and #9). Findings included: Review on 12/06/2023 of the facility policy titled, “Patient Assessment and Monitoring,” Published: 05/01/2023 revealed, “... During Treatment ... Follow the steps below for monitoring patient and machine parameters during treatment... Check machine settings and measurements: Check prescribed blow flow is being achieved or reason is documented in medical record if unable to meet prescribed blow flow...” 1. Review of medical record for Patient #1 revealed a male patient admitted for In-Center Hemodialysis treatments on 12/21/2018. Review of the physician orders revealed Patient #1’s BFR was ordered at 450. Review of the Treatment Flowsheet dated 11/20/2023 revealed Patient #1’s hemodialysis treatment was initiated at 1101 and ended at 1447 (226 minutes). Review of the Flowsheet revealed Patient #1’s BFR average was 380 with no documentation for the decreased BFR and Registered Nurse notification. Review of the Treatment Flowsheet dated 11/24/2023 revealed Patient #1’s hemodialysis treatment was initiated at 1058 and ended at 1439 (221 minutes). Review of the Flowsheet revealed Patient #1’s BFR average was 410 with no documentation for the decreased BFR and Registered Nurse notification. Review of the Treatment Flowsheet dated 12/01/2023 revealed Patient #1’s hemodialysis treatment was initiated at 1055 and ended at 1444 (229 minutes). Review of the Flowsheet revealed Patient #1’s BFR average was 430 with no documentation for the decreased BFR and Registered Nurse notification. Interview on 12/07/2023 at 1035 with the CM revealed the facility’s patient care technicians should notify the nursing staff anytime they increase and/or decrease the patient’s BFR or make any changes outside the ordered prescription and document the reason on the treatment flowsheet. The interview confirmed the medical record findings that Patient #1 had a decreased BFR in 3 of 6 treatments with no documentation for the decreased BFR and Registered Nurse notification. 2. Review of medical record for Patient #4 revealed a male patient admitted for In-Center Hemodialysis treatments on 11/16/2022. Review of the physician orders revealed Patient #4’s BFR was ordered at 450. Review of the Treatment Flowsheet dated 11/22/2023 revealed Patient #4’s hemodialysis treatment was initiated at 0726 and ended at 1055 (209 minutes). Review of the Flowsheet revealed Patient #4’s BFR average was 400 with no documentation for the decreased BFR and Registered Nurse notification. Review of the Treatment Flowsheet dated 11/24/2023 revealed Patient #4’s hemodialysis treatment was initiated at 0715 and ended at 1018 (183 minutes). Review of the Flowsheet revealed Patient #4’s BFR average was 352 with no documentation for the decreased BFR and Registered Nurse notification. Interview on 12/07/2023 at 1035 with the CM revealed the facility’s patient care technicians should notify the nursing staff anytime they increase and/or decrease the patient’s BFR or make any changes outside the ordered prescription and document the reason on the treatment flowsheet. The interview confirmed the medical record findings that Patient #4 had a decreased BFR in 2 of 6 treatments with no documentation for the decreased BFR and Registered Nurse notification. 35306 3. Review of the medical record for Patient #2 revealed a 59-year-old male admitted for In-Center Hemodialysis treatments on 12/14/2021. Review of the Physician orders revealed Patient #2’s BFR was ordered at 450. Review of the Treatment Flowsheet dated 11/23/2023 revealed Patient #2’s hemodialysis treatment was initiated at 0717 and ended at 0925 (128 minutes). Review of the Flowsheet revealed Patient #2’s BFR average was 410 with no documentation for the decreased BFR and Registered Nurse notification. Review of the Treatment Flowsheet dated 11/30/2023 revealed Patient #2’s hemodialysis treatment started at 0655 and ended at 1029 (214 minutes). Review of the Flowsheet revealed Patient #2’s BFR average was 410 with no documentation for the decreased BFR and Registered Nurse notification. Review of the Treatment Flowsheet dated 12/02/2023 revealed Patient #2’s hemodialysis treatment started at 0645 and ended at 1021 (216 minutes). Review of the Flowsheet revealed Patient #2’s BFR average was 440 with no documentation for the decreased BFR and Registered Nurse notification. Interview on 12/07/2023 at 1035 with the CM revealed the facility’s patient care technicians should notify the nursing staff anytime they increase and/or decrease the patient’s BFR or make any changes outside the ordered prescription and document the reason on the treatment flowsheet. The interview confirmed the medical record findings that Patient #2 had a decreased BFR in 3 of 6 treatments with no documentation for the decreased BFR and Registered Nurse notification. 4. Review of the medical record for Patient #6 revealed a 72-year-old male admitted for In-Center Hemodialysis treatments on 04/14/2022. Review of the Physician orders revealed Patient #6’s BFR was ordered at 400. Review of the Treatment Flowsheet dated 11/21/2023 revealed Patient #6’s hemodialysis treatment was initiated at 1208 and ended at 1455 (167 minutes). Review of the Flowsheet revealed Patient #6’s BFR average was 350 with no documentation for the decreased BFR and Registered Nurse notification. Review of the Treatment Flowsheet dated 11/30/2023 revealed Patient #6’s hemodialysis treatment started at 1140 and ended at 1514 (214 minutes). Review of the Flowsheet revealed Patient #6’s BFR average was 300 with no documentation for the decreased BFR and Registered Nurse notification. Interview on 12/07/2023 at 1035 with the CM revealed the facility’s patient care technicians should notify the nursing staff anytime they increase and/or decrease the patient’s BFR or make any changes outside the ordered prescription and document the reason on the treatment flowsheet. The interview confirmed the medical record findings that Patient #6 had a decreased BFR in 2 of 6 treatments with no documentation for the decreased BFR and Registered Nurse notification. 5. Review of the medical record for Patient #9 revealed a 42-year-old male admitted for In-Center Hemodialysis treatments on 05/05/2011. Review of the Physician orders revealed Patient #9’s BFR was ordered at 450. Review of the Treatment Flowsheet dated 11/21/2023 revealed Patient #9’s hemodialysis treatment was initiated at 1047 and ended at 1513 (266 minutes). Review of the Flowsheet revealed Patient #9’s BFR average was 420 with no documentation for the decreased BFR and Registered Nurse notification. Review of the Treatment Flowsheet dated 11/23/2023 revealed Patient #9’s hemodialysis treatment started at 0525 and ended at 0737 (132 minutes). Review of the Flowsheet revealed Patient #9’s BFR average was 410 with no documentation for the decreased BFR and Registered Nurse notification. Review of the Treatment Flowsheet dated 11/28/2023 revealed Patient #9’s hemodialysis treatment started at 1051 and ended at 1417 (206 minutes). Review of the Flowsheet revealed Patient #9’s BFR average was 400 with no documentation for the decreased BFR and Registered Nurse notification. Interview on 12/07/2023 at 1035 with the CM revealed the facility’s patient care technicians should notify the nursing staff anytime they increase and/or decrease the patient’s BFR or make any changes outside the ordered prescription and document the reason on the treatment flowsheet. The interview confirmed the medical record findings that Patient #9 had a decreased BFR in 3 of 6 treatments with no documentation for the decreased BFR and Registered Nurse notification.”