Fmc - Boone County

“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: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure staff performed hand hygiene per facility policy during 1 of 2 observations of dialysis access cannulation. The findings include: Review of the facility’s policy titled, “Access Assessment and Cannulation,” published 05/06/2024, indicated, “Note: To clarify glove changes during the cannulation procedure: After assessing the access, staff must perform hand hygiene and don new gloves. With the new gloves, staff may perform the full cannulation procedure including skin disinfection, lidocaine administration (if applicable) and cannulation. If any of the steps in the procedure are interrupted, hand hygiene must be performed and new gloves must be donned.” Observation on 12/09/2024 at 10:06 AM at Station 13, Patient Care Technician (PCT) 9 assessed a patient’s access by palpation alone, applied antiseptic to the patient’s skin over their access, and then cannulated the access. The PCT failed to perform hand hygiene and change gloves after palpating the patient’s access. During an interview on 12/09/2024 at 2:28 PM, PCT7 stated prior to cannulation, the staff should assess the access and hand hygiene should be completed prior to cannulation. She stated hand hygiene was completed when coming onto the clinic floor, between every patient, between every glove change, and before cannulation. During an interview on 12/09/2024 at 1:20 PM, Registered Nurse (RN) 14 stated hand hygiene and glove changes should be done prior to cannulating a patient’s access. During an interview on 12/11/2024 at 4:30 PM, the Clinic Manager stated staff should wash the patient’s access, assess the access, and then change gloves and perform hand hygiene prior to applying antiseptic to the patient’s access and cannulating.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to implement their infection control policy regarding tuberculosis (TB) testing of new patients, which affected 1 of 4 sampled newly admitted patients, Patient (P) 1. The findings include: Review of the facility’s policy titled, “Patient Tuberculosis [TB] Testing,” published 02/05/2024, indicated, “On admission, review the medical records of each patient to determine if they have received TB testing within the last year.” The policy indicated, “Patient who have no documented TB test within the last year will be tested using the TST [Mantoux Tuberculin Skin Test].” Review of P1’s medical record revealed an “ESRD [End Stage Renal Disease] Comprehensive RN [Registered Nurse] Assessment,” dated 12/09/2024, that revealed a “Visit Date” of 10/28/2024. The record indicated the patient’s “TB Skin Test” status was “Unknown.” During an interview on 12/10/2024 at 12:15 PM, the Clinic Manager stated the “Visit Date” on the “Comprehensive RN Assessment” form was the first treatment date in the center. Review of P1’s “Tuberculosis Skin Test Administration Record” revealed a TB skin test was given on 12/04/2024 and was read on 12/06/2024 with a negative reaction. During an interview on 12/10/2024 at 9:50 AM, the Clinic Manager stated there was no evidence that P1 had a TB test within the previous year. The Clinic Manager stated the patient should have had one completed at the time of admission. During an interview on 12/12/2024 at 3:37 PM, the Medical Director stated the expectation was that TB skin testing be completed on all new patients per facility policy.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility policy review, the facility failed to conduct an initial comprehensive assessment within 30 days or 13 treatments for 1 of 4 sampled newly admitted patients, Patient (P) 1. The findings include: Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 07/03/2023, indicated, “An initial comprehensive interdisciplinary assessment (CIA) and plan of care (POC) must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. Patients changing modality are classified as new patients and must have comprehensive interdisciplinary assessments and plans of care completed with the same frequency as patients new to dialysis.” Review of P1’s “Treatment Sheet Archive” revealed P1 had 18 treatments between admission and completion of the initial comprehensive assessment. The date of the thirteenth treatment was 11/26/2024. Review of P1’s “ESRD [End Stage Renal Disease] Comprehensive RN [Registered Nurse] Assessment,” dated 12/09/2024, revealed a “Visit Date” of 10/28/2024, and thirty calendar days from the visit date would have been 11/27/2024. Therefore this initial comprehensive assessment was 12 days late. During an interview on 12/10/2024 at 12:15 PM, the Clinic Manager stated the “Visit Date” was the patient’s first date in the clinic. During an interview on 12/10/2024 at 9:50 AM, RN12 stated P1 had one home peritoneal dialysis session on 11/20/2024, at which time they decided to go back to in-center treatments. During an interview on 12/10/2024 at 9:50 AM, the Clinic Manager stated the staff thought they had an extra 30 days to complete the comprehensive assessment due to the patient changing modalities. During an interview on 12/10/2024 at 11:45 AM, the Director of Operations stated the patient should have had an initial comprehensive assessment within the initial 30 days despite changing modalities. During an interview on 12/12/2024 at 3:37 PM, the Medical Director stated the expectation was that an initial comprehensive assessment be completed for all new patients within 30 days or per facility policy.”

“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: 50873 Based on interview, record review, and facility policy review, the facility failed to provide the necessary care and services to manage the patients’ volume status for 4 of 7 patients sampled for treatment record review, Patient (P) 1, P3, P4, and P6) . The facility failed to ensure staff reported out-of-range vital signs to a Registered Nurse (RN). The findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed, “If the PCT [patient care technician]/LPN [licensed practical nurse] note 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 policy instructed staff to, “Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations.” The policy instructed staff to, “Record blood pressure.” The policy instructed staff to, “Report to the nurse: Systolic blood pressures greater than 180 mm/Hg [millimeters of mercury], Diastolic blood pressure greater than 100 mm/Hg, Blood Pressure less than or equal to 100 mm/Hg systolic.” The policy instructed staff to, “Record Pulse.” The policy instructed staff to “Report to the nurse patients whose heart rates have dropped below 60, risen above 100 or become irregular.” 1. Review of P1’s “Treatment Sheet for Facility: [facility name],” dated 11/18/2024, revealed staff documented the following heart rates: 47 at 12:33 PM, taken by PCT7; 45 at 1:01 PM, taken by LPN15; 48 at 1:31 PM, taken by PCT7; 48 at 2:03 PM, taken by PCT7; 55 at 2:48 PM, taken by PCT7; 57 at 3:08 PM, taken by PCT7; 51 at 3:38 PM, taken by PCT7; and 51 at 4:00 PM, taken by PCT7. There was no evidence of an RN being notified related to the out-of-range vital signs. Review of P1’s “Treatment Sheet for Facility: [facility name],” dated 11/22/2024, revealed staff documented the following heart rates: 51 at 12:34 PM, taken by PCT7; 52 at 12:47 PM, taken by PCT7; 50 at 1:03 PM, taken by PCT7; and 54 at 1:30 PM, taken by PCT7. There was no evidence of an RN being notified related to the out-of-range vital signs. Review of P1’s “Treatment Sheet for Facility: [facility name],” dated 11/24/2024, revealed at 10:24 AM staff documented a pre-treatment heart rate of 55 that had an irregular rhythm, taken by PCT9. There was no evidence of notification to the RN of this abnormal assessment finding. In addition, staff documented the following heart rates: 53 at 10:31 AM, taken by PCT9; 46 at 11:01 AM, taken by PCT9; 48 at 11:33 AM, taken by PCT9; and 45 at 12:01 PM, taken by PCT9. There was no evidence of an RN being notified related to the out-of-range vital signs. 2. Review of P3’s “Treatment Sheet for Facility: [facility name],” dated 11/29/2024, revealed staff documented the following blood pressures: 100/56 mm/Hg at 9:51 AM, taken by PCT9; 99/51 mm/Hg at 10:02 AM, taken by PCT9; 95/50 mm/Hg at 10:31 AM, taken by PCT9; 95/51 mm/Hg at 11:02 AM, taken by PCT9. There was no evidence of an RN being notified related to the out-of-range vital signs. 3. Review of P4’s “Treatment Sheet for Facility: [facility name],” dated 11/19/2024, revealed staff documented the patient had a blood pressure of 162/129 mm/Hg at 6:47 AM, taken by PCT17. There was no evidence of an RN being notified. Review of P4’s “Treatment Sheet for Facility: [facility name],” dated 11/23/2024, revealed staff documented the patient had a blood pressure of 97/51 mm/Hg at 9:03 AM, taken by PCT9. There was no evidence of an RN being notified. Review of P4’s “Treatment Sheet for Facility: [facility name],” dated 11/25/2024, revealed staff documented the following blood pressures: 196/93 mm/Hg at 6:04 AM, taken by PCT17; 205/94 mm/Hg at 6:16 AM, taken by PCT17; and 94/50 mm/Hg at 7:00 AM, taken by PCT17. There was no evidence of an RN being notified related to these out-of-range vital signs. Review of P4’s “Treatment Sheet for Facility: [facility name],” dated 11/30/2024, revealed staff documented the following blood pressures: 190/96 mm/Hg at 6:07 AM, taken by PCT9; 196/100 mm/Hg at 7:06 AM, taken by PCT9; and 201/70 mm/Hg at 8:32 AM taken by PCT9. There was no evidence of an RN being notified related to the out-of-range vital signs. 4. Review of P6’s “Treatment Sheet for Facility: [facility name],” dated 11/18/2024, revealed staff documented the patient had a heart rate of 47 at 7:33 AM, taken by PCT9; and a blood pressure of 156/122 mm/Hg at 10:01 AM, taken by PCT9. There was no evidence of an RN being notified related to the out-of-range vital signs. Review of P6’s “Treatment Sheet for Facility: [facility name],” dated 11/26/2024, revealed staff documented the patient had a blood pressure of 162/118 mm/Hg at 12:46 PM, taken by PCT7. There was no evidence of an RN being notified related to the out-of-range blood pressure. During an interview on 12/09/2024 at 2:28 PM, PCT7 stated she would notify the nurse for systolic blood pressures under 100 mm/Hg or for a pulse rate below 60. During an interview on 12/09/2024 at 1:20 PM, RN14 stated PCTs should report systolic blood pressures above 160 mm/Hg, below 100 mm/Hg, or heart rates below 60. During an interview on 12/10/2024 at 9:50 AM, the Clinic Manager stated the expectation was that an RN be notified and the notification to be documented when any heart rate was lower than 60, systolic blood pressure was greater than 180 mm/Hg or lower than 100 mm/Hg, or diastolic blood pressure was greater than 100 mm/Hg or lower than 50 mm/Hg. She stated an LPN had the same reporting requirements as PCTs related to vital signs that were out-of-range. She stated PCTs were to report to an RN, not an LPN. The Clinic Manager stated the expectation for the RN upon being notified of out-of-range vital signs was to assess the patient, maybe recheck the vital signs, assess if as needed (PRN) medications were needed and administer if needed, and document the assessment and/or the interventions. During an interview on 12/12/2024 at 3:37 PM, the Medical Director stated the expectation was for a nurse to be notified of out-of-range vital signs per the facility 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: 50873 Based on interview, record review, and facility policy review, the facility failed to follow the individualized dialysis prescription as determined by the medical provider for 3 of 7 patients sampled for treatment record review, Patient (P) 1, P3, and P4. The findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed, “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.” 1. Review of P1’s “Treatment Sheet for Facility: [facility name],” dated 11/26/2024, revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min). The record revealed staff documented the treatment BFR was 300 mL/min from 11:32 AM to 2:01 PM. The record revealed no evidence of documentation of a rationale for why the treatment deviated from the prescribed treatment order. 2. Review of P3’s “Treatment Sheet for Facility: [facility name],” dated 11/24/2024, revealed a prescribed dialysis flow rate (DFR) of 500 milliliters per minute (mL/min). The record revealed staff documented the treatment DFR was 800 mL/min from 9:45 AM to 10:40 AM. The record revealed no evidence of documentation of a rationale for why the treatment deviated from the prescribed treatment order. 3. Review of P4’s “Treatment Sheet for Facility: [facility name],” dated 11/25/2024, revealed a prescribed blood flow rate (BFR) of 250 milliliters per minute (mL/min). The record revealed staff documented the treatment BFR was 300 mL/min from 6:04 AM to 9:34 AM. The record revealed no evidence of documentation of a rationale for why the treatment deviated from the prescribed treatment order. During an interview on 12/09/2024 at 2:28 PM, Patient Care Technician (PCT) 7 stated if she identified that a treatment was set for the incorrect BFR, she would correct it, document it, and tell the nurse. During an interview on 12/09/2024 at 1:20 PM, Registered Nurse (RN) 14 stated if the BFR or DFR was not entered into the machine as ordered, she would discuss it with the person who set up the patient machine for treatment and ask why it was different from the order. She stated she would then ask the staff member to document the rationale why and reinforce the need to notify the RN. During an interview on 12/11/2024 at 4:30 PM, the Clinic Manager stated the expectation was that if the staff was unable to achieve the ordered BFR, there should be documentation to explain why. The Clinic Manager stated there was no reason for deviation from the ordered DFR and would expect this to be as ordered. During an interview on 12/12/2024 at 3:27 PM, the Medical Director stated the facility expectation was that the dialysis prescription be followed as ordered and any deviations be documented.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 50873 Based on observation, interview, and facility policy review, the facility failed to monitor a patient’s dialysis access per facility policy during 1 of 2 observations of dialysis access cannulation. The findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed, “Follow the steps below for obtaining pre-treatment assessment data,” which included, “Record access findings. Evaluate the patient’s access per policy: Ask: complaints of pain, numbness, tingling, coldness and tenderness, fever.” The policy revealed, “Look, Listen, Feel.” Review of the facility’s policy titled, “Access Assessment and Cannulation,” published 05/06/2024, revealed, “Listen:” included, “NOTE: Staff/patients/care partners who have been trained to auscultate vascular accesses should listen to the entire length of the access for changes in the sound of the bruit - a normal low-pitched bruit should be present.” Observation on 12/09/2024 at 10:06 AM revealed Patient Care Technician (PCT) 9 entered patient treatment Station 13. The PCT performed hand hygiene, donned clean gloves, applied a tourniquet, palpated the patient’s dialysis access, applied antiseptic to the patient’s access, and inserted cannulation needles. The PCT did not auscultate the patient’s access prior to cannulation. During an interview on 12/09/2024 at 2:28 PM, PCT7 stated access assessments should be completed prior to cannulation and should include “look, listen, and feel.” During an interview on 12/09/2024 at 1:20 PM, Registered Nurse (RN) 14 stated the expectation was that staff assessed the patient’s dialysis access prior to cannulation, and that assessment included “look, listen, and feel.” During an interview on 12/11/2024 at 4:30 PM, the Clinic Manager stated the expectation was that staff assessed the patient’s dialysis access prior to cannulation, and that assessment should include palpation and auscultation. During an interview on 12/12/2024 at 3:27 PM, the Medical Director stated the expectation was that auscultation be conducted as a routine part of dialysis access assessment prior to each cannulation.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 50873 Based on observation, interview, document review, and facility policy review, the facility failed to safeguard protected health information (PHI) by failing to securely store a “Patient Info [information] Binder” containing PHI of 46 patients. This had the potential to affect all patients receiving care in the facility. The findings include: Review of the facility’s policy titled, “HIPAA [Health Insurance Portability and Accountability Act] Privacy Policies and Procedures,” revised 04/16/2024, indicated, “Paper copies of PHI will be stored in locked offices, file rooms, cabinets, or desk drawers. Access will be limited to individuals who require access to perform their job duties.” During an observation and interview on 12/06/2024 at 2:14 PM, a binder titled, “Patient Info [information] Binder” was observed on a shelf next to the medication refrigerator. Inside was a document titled, “Emergency Disaster Patient Contact List - Verified,” dated 11/28/2022. The documents revealed, “This form contains confidential information, keep in the Emergency Supply Box or Cart.” The documents revealed the clinic’s name and internal company clinic number and contained the names, medical record numbers, date of birth, address, phone number, hepatitis B immunity status, emergency contact information, transportation, and dialysis treatment schedule for 46 patients who were receiving care at the clinic at the time the report was printed. The contents of the folder were reviewed with the Clinic Manager at the time of the observation. During an interview at that time, the Clinic Manager stated she did not know it was there. She stated the binder contained PHI of patients and should be stored securely to prevent unauthorized access to patient PHI. The Clinic Manager stated the binder being kept on the shelf would not be considered secure. During an interview on 12/12/2024 at 3:27 PM, the Medical Director confirmed the expectation would be for all patient information to be stored securely.”