Mt Pleasant Dialysis Center

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 48749 Based on observation, record review, and interview, the facility staff failed to clean and disinfect contaminated surfaces and equipment in 3 (In-Center Treatment Area, Water Room, Laboratory) of 3 areas. Also, the facility staff failed to follow the “General Cleanliness and Infection Control Guidelines” policy. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by allowing supplies and equipment to be used that had been exposed to microbial contamination and unclean surfaces. Findings include: During a tour of the facility’s in-center treatment area on 12/02/2024 at 11:30 AM, the following infection control issues were observed: In-Center Treatment Area: * There were two footstools with a build-up of dust particles and an unknown dried yellow liquid. *There was a clutter of dialysis supplies on all of the counters in the in-center treatment floor area. *There was a black cart next to the lab with an accumulation of dust and an unknown dried white liquid on the top and bottom rack. *There were dead insects in the light covers. * There were seven oxygen concentrators (medical equipment that takes in room air and filters out nitrogen to provide higher oxygen concentration) with a build-up of dust and debris on the exterior surfaces. * There was a shelf at the door of the in-treatment center cluttered with patients’ personal items and the sling for the patients’ Hoyer lift (a device used to lift immobile patients). * There was an expired bottle of blood leak strips (used to confirm if a blood leak on a dialysis machine is triggered by an actual blood leak or a false alarm) with a date of 11/30/2024 in the crash cart. * There was an accumulation of dirt and debris on the floor throughout the center. * There was dried blood on the side tray of a dialysis chair. * There were open syringes with needles loose in a drawer in the medication prep area. The surveyor was unable to determine an expiration date. *There was a lab pole with multiple used gowns sitting in the isolation room. *The blood pressure cuffs in the isolation room had a build-up of lint on the velcro. *The was an expired bag of hand soap in the isolation room with a date of 02/2022. *There was a blue pad (disposale medical underpad) on the desk at the nurse’s station. The staff reported this was being used as a medication prep area. There was a clutter of paper and supplies around this area. Water Room: * There was an accumulation of dust and debris on the bottom shelf of the storage rack. * There was a build-up of dust, debris, hair, and dead insects on the floor under the storage rack. Laboratory: *There was an accumulation of dust, debris, and an unknown dried brown substance on the bottom of the plastic container holding clamps. *There were cardboard boxes broken down inside the lab freezer. There was an accumulation of dust and cardboard particles on the bottom of the lab freezer. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items).” A review of the policy titled, “General Cleanliness and Infection Control Guidelines” dated July 2024 revealed the following: “PURPOSE: The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. DISINFECTION * All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices. Walkways must be kept clear of debris and free of clutter. * Facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection. * Eating, drinking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. * Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or benchtops where blood or other potentially infectious materials are present. * Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping. * Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility. * Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station. * Clean supplies may not be kept under dirty sinks. * Fans may not be used in treatment areas. (ex floor fans, box fans, individual portable fans).” An interview on the morning of 12/03/2024 with Staff #2, acknowledged the infection control issues found during the in-center tour and that staff failed to follow the “General Cleanliness and Infection Control Guidelines” policy.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility’s direct care staff failed to change gloves and perform hand hygiene between patient encounters and before touching dialysis equipment and sterile supplies in 1 of 1 patient encounters. The facility staff failed to follow, “Personal Protective Equipment” policy. This deficient practice had the likelihood to lead to the transmission of infectious agents between staff members and the patients being treated at the facility. Findings include: During a tour of the facility’s in-center treatment area on 12/02/2024 at 11:30 AM the surveyor observed Staff # 20 (CCHT) touch the dialysis machine at station # 3 and proceed to touch the patient and patient supplies located at station # 3 without changing gloves and performing hand hygiene. Staff # 20 proceeded to dialysis station # 1 and touched the machine and dialysis chair with the same gloves on. No hand hygiene was performed. A review of the facility policy, “Personal Protective Equipment” with a date of 11/06/2023 revealed, “ ...Gloves: A supply of clean, non-sterile gloves and a waste container shall be placed near each dialysis station or treatment area. Staff must remove gloves and wash hands after: *Patient care *Exposure to blood and body fluids *Touching any surfaces within the patient station ...Always perform hand hygiene after glove removal ...” An interview with Staff # 1 on 12/02/2024 at 4:00 PM confirmed Staff # 20 was seen interacting with multiple patient dialysis stations without changing gloves and performing hand hygiene.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility staff failed to ensure that 4 (Heparin syringes) of 4 medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. The staff failed to follow the “Medication Preparation and Administration” policy. Findings include: During a tour of the facility’s in-center treatment area on 12/02/2024 at 11:30 AM, the surveyor observed 4 syringes containing Heparin (a drug used to prevent the blood from clotting) unsecured throughout the treatment floor. Two syringes of Heparin were found sitting on the chair at station # 2. There were no staff members at station # 2 at the time of the observation. The syringes were accessible to unauthorized persons and were not safeguarded for more than 25 minutes. Two syringes of Heparin were sitting on the chair at station # 16. There were no staff members at station # 16 at the time of the observation. The syringes were accessible to unauthorized persons and were not safeguarded for more than 5 minutes. A review of the facility’s policy, “Medication Preparation and Administration” with a date of 02/06/2023 revealed, “PURPOSE: To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control .... Medications may be pre-drawn up to 4 hours prior to administration. These pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated medication storage area or refrigerated if necessary, until delivery to the appropriate patient for administration,,,” An interview with Staff # 1 on 12/02/2024 at 4:00 PM confirmed the staff were leaving syringes of Heparin at the dialysis station without proper safeguarding.”

“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: 48653 Based on observation, record review, and staff interview, the facility’s direct care staff failed to ensure the patient’s dialysis access site was always visible during treatment on 4 (Patient # 2, # 9, and # 12, # 13) of 10 patient observations. The facility staff failed to follow the policy, “Patient Monitoring During Patient Treatment”. Ensuring proper visualization of the dialysis access is important for the early recognition and prevention of bleeding from the patient’s access site. Findings include: During a tour of the facility’s in-center treatment area on 12/02/2024 at 11:45 AM, the surveyor observed Patients # 2, # 9, and # 12, receiving dialysis treatment. The patients were covered with personal blankets and their dialysis access sites were not visible. The staff were unable to visualize the dialysis access sites to ensure there was no needle dislodgement or active bleeding from the site. During a tour of the facility’s in-center treatment area on 12/03/2024 at 10:00 AM, the surveyor observed Patient # 13 receiving dialysis treatment. The patient’s head and access site were covered so that the staff could not assess the patient or access site to determine if there was needle dislodgement or active bleeding. A review of the facility policy, “ Patient Monitoring During Patient Treatment” with a date of 08/20/2014 revealed, “PURPOSE: The purpose of this policy is to provide direction for monitoring dialysis patients during treatment. POLICY: Monitor the patient at the initiation of treatment and every 30 minutes, or more frequently as necessary. Observation: All patients must be under visual observation by FMS Clinical Staff during treatment ....Ensure each patient’s face is visible and uncovered ... Access: Observe and document at the initiation of dialysis and at every safety check that all connections are secure and visible ...Ensure access remains uncovered throughout treatment ...” An interview was conducted with Staff # 1 on 12/02/2024 at 4:00 PM. Staff # 1 acknowledged that the staff were not ensuring patients’ faces and access were uncovered and visible at all times throughout treatment.”

“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: 48749 Based on record review and staff interview, the facility staff failed to follow the physician’s prescribed orders for the blood flow rate (BFR) and the dialysis flow rate (DFR) in 5 (Patient # 2, # 3, # 4, # 5, and # 7) of 7 medical records reviewed. The facility staff failed to follow the “Patient Assessment and Monitoring” policy. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders which could negatively impact the effectiveness and adequacy of the dialysis treatment for all 71 in-center hemodialysis patients receiving care at the facility. Findings include: Patient # 2 A review of the treatment sheet dated 11/20/2024 revealed the following, “Dialysis Prescription: DFR (dialysis flow rate): 500ml/min (milliliters per minute) BFR (blood flow rate): 400 ml/min” The patient’s set DFR (dialysis flow rate) throughout treatment was “800 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. Patient # 3 A review of the treatment sheet dated 11/06/2024 revealed the following, “Dialysis Prescription: DFR: 500ml/min BFR: 400 ml/min” The patient’s set DFR throughout treatment was “600 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 11/11/2024 revealed the following, “Dialysis Prescription: DFR: 500ml/min BFR: 400 ml/min” The patient’s set DFR throughout treatment was “600 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. Patient # 4 A review of the treatment sheet dated 11/18/2024 revealed the following, “Dialysis Prescription: DFR: 500ml/min BFR: 400 ml/min” The patient’s set DFR throughout treatment was between “600 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. Patient # 5 A review of the treatment sheet dated 11/27/2024 revealed the following, “Dialysis Prescription: DFR: 800ml/min BFR: 400 ml/min” The patient’s set DFR throughout treatment was “500 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 11/30/2024 revealed the following, “Dialysis Prescription: DFR: 800ml/min BFR: 400 ml/min” The patient’s set DFR throughout treatment was “500 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. Patient # 7 A review of the treatment sheet dated 11/18/2024 revealed the following, “Dialysis Prescription: DFR: 800ml/min BFR: 450 ml/min” The patient’s set DFR throughout treatment was “500 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 11/22/2024 revealed the following, “Dialysis Prescription: DFR: 500ml/min BFR: 450 ml/min” The patient’s set DFR throughout treatment was between “ 600-700 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 11/24/2024 revealed the following, “Dialysis Prescription: DFR: 500ml/min BFR: 450 ml/min” The patient’s set DFR throughout treatment was between “500-600 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. A review of the treatment sheet dated 11/26/2024 revealed the following, “Dialysis Prescription: DFR: 500ml/min BFR: 450 ml/min” The patient’s set BFR throughout treatment was “400 ml/min and the DFR was 700 ml/hr”. There was no documented order from the physician to adjust the BFR or DFR for this treatment date. A review of the treatment sheet dated 11/29/2024 revealed the following, “Dialysis Prescription: DFR: 500ml/min BFR: 450 ml/min” The patient’s set DFR throughout treatment was “600 ml/min”. There was no documented order from the physician to adjust the DFR for this treatment date. A review of the facility’s “Patient Assessment and Monitoring” policy dated 05/01/2023 revealed the following: “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. 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.” An interview with Staff # 1 on 11/04/2024 at 11:00 AM confirmed the facility staff was not consistently following the physician’s order for blood flow rate and dialysis flow rate.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 48749 Based on record review and interview, the facility staff failed to ensure direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the Charge Nurse (CN) for further assessment and intervention on 3 (# 2, # 4, and #8) of 7 patient charts reviewed. Also, the facility Charge Nurse failed to report patient vital signs that fell outside the facility’s set parameters to the Physician. The facility staff failed to follow the facility’s “Patient Assessment and Monitoring” policy. Findings include: Patient # 2 A review of the treatment sheet dated 11/20/2024 for Patient # 2 revealed that Staff #12 reported abnormal vital signs to Staff # 6. Further review revealed that Staff # 6 did not alert the physician of abnormal vital signs during treatment. Staff # 12 documented the following on 11/20/2024: “11:10 AM: BP (blood pressure): 204/99; HR (heart rate): 54 11:31 AM: BP: 198/117; HR: 90 12:00 PM: BP 205/91; HR: 60 1:30 PM: BP 198/100; HR: 82 2:00 PM: BP 169/90; HR: 59” There is no documentation from Staff # 6 to support the Physician being made aware of these abnormal vital signs during Patient # 2’s treatment on 11/20/2024. A review of the treatment sheet dated 11/22/2024 for Patient # 2 revealed that Staff #12 reported abnormal vital signs to Staff # 6. Further review revealed that Staff # 6 did not alert the physician of abnormal vital signs during treatment. Staff # 12 documented the following on 11/22/2024: “1:00 PM: BP 183/84; HR: 56 1:30 PM: BP 190/92; HR: 57 2:00 PM:169/91; HR: 53” There is no documentation from Staff # 6 to support the Physician being made aware of these abnormal vital signs during Patient # 2’s treatment on 11/22/2024. Patient # 4 A review of the treatment sheet dated 11/26/2024 for Patient # 4 revealed Staff # 13 did not alert the charge nurse (CN) of abnormal vital signs during treatment. Staff # 13 documented the following on 11/26/2024: “1:30 PM: HR: 76 2:00 PM: HR: 103” There is no documentation from Staff # 13 to support the charge nurse being made aware of these abnormal vital signs during Patient # 4’s treatment on 11/26/2024. Patient # 8 A review of the treatment sheet dated 11/13/2024 for Patient # 8 revealed that Staff # 9 reported abnormal vital signs to Staff # 5. Further review revealed that Staff # 5 did not alert the physician of abnormal vital signs during treatment. Staff # 9 documented the following vital signs on 11/13/2024: “7:06 AM: BP 115/65; HR: 84 7:30 AM: BP 93/47; HR: 71 7:46 AM: BP 149/70; HR: 71” There is no documentation from Staff # 5 to support the physician being made aware of these abnormal vital signs during Patient # 6’s treatment on 11/13/2024. A review of the facility’s “Patient Assessment and Monitoring” policy dated 05/01/2023 revealed the following; “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. Data Collection: Direct patient care staff may collect data such as weight, BP, pulse, respirations, temperature, general observations, access, and complaints reported by the patient. If the PCT/LPN notes any changes or abnormal findings in the patient’s condition or vascular access are observed or reported by the patient, or the patient was hospitalized, the registered nurse must assess the patient. *The RN will notify the patient’s physician/physician extender of any abnormal findings, if necessary, based on clinical judgment for additional instruction. * Recheck blood pressures after a drop that requires interventions such as administering normal saline. * Reposition electronic cuff or use a manual cuff for aberrant blood pressure readings. Report to the nurse: *Systolic blood pressures greater than 180mm/Hg or Diastolic blood pressure greater than 100 mm/Hg. *Blood Pressure less than or equal to 100mm/hg systolic. Verify pulses manually if automated readings display below 60 or greater than 100 beats per minute. *Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or become irregular.” Further review of the facility’s “Reportable Parameters” revealed the following; “ BP: Systolic >180 or Diastolic >110 Systolic < 90 Change in systolic by >20 points HR: < 60 or >110 Increased or decreased by 15” An interview with Staff # 1 on 12/03/2024 at 11:00 AM confirmed the facility staff were not consistently reporting out-of-parameter vital signs to the Charge Nurse and the physician.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 29191 Based on record review and interview, the Interdisciplinary Team failed to ensure that the patient and/or designee was recognized as a member of the Interdisciplinary Team and encouraged to participate in the Plan of Care for 7 of 7 patients (patient #2 through #8). The facility staff failed to follow the facility policy “Comprehensive Interdisciplinary Assessment and Plan of Care”. Findings include: A review of Patient #2 through #8 Plan of Care did not include the patient or designee’s signature to acknowledge that the Patient had reviewed and/or participated in the plan of care as part of the Interdisciplinary team. A review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/23/2023 revealed the following: “General Policy for Patient Assessment and Plan of Care The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, the patient or patient’s designee, a registered nurse, the patient’s attending physician (or physician extender where allowed by State regulations), qualified master’s degree level social worker, and qualified registered dietitian. Patient Participation in Plan of Care The following are recommendations for involving the patient in the development and review of the Plan of Care: * Provide appropriate patient education to enable the patient to participate in the development 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. * Review expectations for participation in the Plan of Care with each patient. * Review this expectation again when Rights and Responsibilities are reviewed.” An interview with Staff #2 on 12/03/2024 at 10 AM confirmed that Staff #18 had failed to send invites to the patient and/or designee for an Interdisciplinary Team meeting to discuss the plan of care.”

“GOV-STAFF HAVE ACCESS TO CONTINUING ED CFR(s): 494.180(b)(4) The governing body or designated person responsible must ensure that- (4) All employees have an opportunity for continuing education and related development activities This Standard is not met as evidenced by: 29191 Based on record review and interview, the Facility Administrative Staff failed to ensure the Registered Nurse and technical staff had at least 5 CEUs (continuing education credits) annually which were related to end-stage renal disease for 3 (#5, #9, and #20) of 4 staff personnel files reviewed. Findings include: A review personnel file for Staff #5 (Registered Nurse) revealed 1 hour of documented continuing education units. Staff #5 (Registered Nurse) did not have at least 5 CEUs relating to end-stage renal disease in the past year. A review personnel file for Staff #9 (CCHT) certified clinical hemodialysis technician revealed 2 hours of documented continuing education units. Staff #9 (CCHT) did not have at least 5 CEUs relating to end-stage renal disease in the past year. A review personnel file for Staff #20 (CCHT) certified clinical hemodialysis technician revealed no hours of documented continuing education units. Staff #20 (CCHT) did not have at least 5 CEUs relating to end-stage renal disease in the past year. An interview with Staff #1 on 12/02/2024 at 3:00 PM confirmed the technical staff did not have at least 5 CEUs relating to end-stage renal disease in the past year.”