Davita Clearfield Dialysis

“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: 44820 Based on employee (EMP) interviews, observations (OBS), review of facility policy and an interview with the facility administrator, the facility failed to ensure staff/employees follow its policy for medication preparation for one (1) of two (2) medication preparation observations (OBS#1). Findings include: A review of policy, 1-06-01A “Preparation and Administration of Parenteral Medications (Non EPO, Non-Parsabiv) With All Dialyzer Types” on November 19, 2024 at approximately 11:00 AM states: ...”7. If the medication is in a vial, remove the vial cap, and clean vial stopper with an alcohol prep pad...” Observation of the treatment area was conducted on November 20, 2024, from approximately 9:00 A.M. to 11:30 A.M. OBS#1 was conducted on November 20, 2024 at approximately 9:20 A.M. Medication preparation performed by EMP#3. EMP#3 failed to utilize alcohol prep pad per policy and procedure and did not wipe the vial of Ferrlecit with alcohol or other antiseptic prior to entering the vial with a needled 10cc syringe. EMP#3 states “Since the vial is new and I just popped the seal I do not have to wipe with alcohol.” An interview with the facility administrator on November 20, 2024, at approximately 11:00 A.M. confirmed the above findings.”

“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: 44820 Based on review of policy, clinical records (CR) and interview with the facility administrator the clinic failed to ensure the nurse documented interventions for the patient leaving treatment more than 1 kg over the estimated dry weight, the clinic failed to ensure documentation of interventions for “abnormal findings” per policy, the clinic failed to ensure facility staff notified and documented that the nurse was notified if patient BP’s recorded contained systolic greater than 180 mm/Hg or below 90 mm/Hg, the clinic failed to ensure patient received medications as prescribed by the physician, the clinic failed to ensure and document that the patient received the prescribed dialysis treatment time and the clinic failed to ensure all medications orders contained frequency and parameters for administration, the clinic failed to ensure physician was notified for two (2) of four (4) records reviewed (CR#2& CR#4). no CR4 data below Findings include: Review of Policy “1-03-08” TITLE: “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” completed on 11/5/2024 at approximately 11:00 AM revealed: PURPOSE: “To obtain and document baseline and ongoing inforamtion about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring duringtreatment and for reviewing the patient’s response to treatment and status prior to discharge... POLICY: 1. Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. a. Data collection includes butisnotnecessarily limited to:... ii. Measurement of Blood Pressure (BP); 1. Sitting and standing BP measurement required pre and post treatment (if patient unable to stand, document reason in patient electronic record or flow sheet)... PRE-TREATMENT DATA COLLECTION/ASSESSMENT; 4. Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse... 10. If the dialysis prescription is not being met... the reason will be documented and the licensed nurse informed... 13. All findings, interventions and patient response will be documented in the patient’s medical record... 16. If an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse... 17. Licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions or notification of physician is necessary prior to discharge of the patient from the facility... ABNORMAL FINDINGS; ... The following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient’s medical record... Fluid Status... Post-treatment: If patient is above or below 1 kg from the target weight... Blood Pressure: Pre-dialysis: Systolic greater than 180mm/Hg or less than 90mm/Hg... Blood Pressure-Intradialytic: Systolic greater than 180mm/Hg or less than 90mm/Hg... Blood Pressure Post Treatment: If the patient can stand: standing Systolic BP greater than 140mm/Hg or less than 90mm/Hg; If patient is not able to stand, document reason and sitting BP... Pre/Intra/Post Patient Reports/Complaints and/or teammate observation of:... Weakness or numbness... Changes in mobility, ambulation or reports of falls...” Review of CR’s completed on 11/19/2024 between approximately 8:45 AM and 12:00PM revealed: CR#2, Admit date: 1/11/2023; Mobility: walker; ambulates - no assistance needed. Treatment date: 11/1/2024: Mobility: walker; ambulates - no assistance neededTarget weight prescribed - 74.5 kg - pre-weight recorded 72.3 kg(kilograms) post weight recorded 71.3kg. Standing BP not documented pre-treatment, standing BP not documented post-treatment. No documented interventions by nurse/no physician notification documented. Treatment date: 11/4/2024: Mobility: ambulates - no assistance needed; standing BP not documented post-treatment; No documented interventions by nurse/no physician notification documented. Treatment date: 11/6/2024: post weight documented 72.5kg - target weight prescribed 71.0kg; No documented interventions by nurse/no physician notification documented. Treatment date: 11/8//2024: post weight documented 73.7kg - target weight prescribed 71.0kg; No documented interventions by nurse/no physician notification documented. Treatment date: 11/11/2024: post weight documented 74.1kg - target weight prescribed 71.0kg; No documented interventions by nurse/no physician notification documented. Treatment date: 11/13/2024: Mobility: ambulates - no assistance needed; standing BP not documented pre-treatment; post weight documented 73.2kg - target weight prescribed 71.0kg; No documented interventions by nurse/no physician notification documented. Treatment date: 11/15/2024: post weight documented 72.7kg - target weight prescribed 70.0kg; No documented interventions by nurse/no physician notification documented. CR#4, Admit date: 8/28/2024; Mobility: ambulates - no assistance needed. Treatment date: 11/11/2024: 11:31 AM - intra-dialytic BP documented 212/115mm/Hg; 11:41 AM clonidine 0.1 mg documented by RN as administered; clonidine orders do not contain parameters for administration or frequency; No documented interventions by nurse/no physician notification documented. Treatment date: 11/15/2024: 11:29 AM - intra-dialytic BP documented by PCT -181/95mm/Hg; 12:29 PM - intra-dialytic BP documented by PCT - 184/107mm/Hg; 12:59 PM - intra-dialytic BP documented by PCT - 193/106mm/Hg; 13:14 PM - RN documents patient complaint of Headache and administered Tylenol - no documentation of BP monitoring/check by RN; 13:29 PM - intra-dialytic BP documented by RN- 206/109mm/Hg; 13:31 PM - intra-dialytic BP documented by RN - 172/139mm/Hg clonidine 0.1 mg documented by RN as administered; clonidine orders do not contain parameters for administration or frequency; No documented notification to RN by PCT, no interventions by nurse/no physician notification documented. Interview with the Facility Administrator completed 11/19/2024 at approximately 2:30PM confirmed the above findings.”

“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: 44820 Based on a review of clinical records (CR), facility policy, and an interview with the facility administrator, the agency failed to ensure that an initial comprehensive assessment was conducted on all new patients within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session for two (2) of four (4) CR’s reviewed: (CR#2 and CR#3). A review of Policy 1-14-01 conducted on 11/19/2024 at approximately 1:30 PM revealed: “TITLE: Interdisciplinary Team Patient Assessment and Plan of Care... ASSESSMENT: The facility’s interdisciplinary team (IDT) consistsof, at a minimum, the patient or the patient’s personal representative, a registered nurse, a physician or Non-Physician Practioner (NPP), ifallowed by state ESRD licensure regulations, treatingthe patient for ESRD, a social worker, and qualified renal dietitian per CMS... 4. A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines...” A review of Clinical Records was conducted on 11/19/2024 from approximately 8:30 AM to 11:30 AM. CR#2 admit date: 01/11/2023 did not have the initial comprehensive assessment completed until 03/27/2023, 75 days after the beginning of the first dialysis session. CR#3 admit date: 01/25/2023 did not have the initial comprehensive assessment completed until 03/27/2023, 61 days after the beginning of the first dialysis session. An interview conducted with the facility administrator on 11/19/2024 at approximately 2:00 PM confirmed the above findings.”

“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: 44820 Based on a review of facility policies, clinical records (CRs), interview with facility administrator, registered nurse (RN) interviews and Patient Care Technician (PCT) interviews, the facility failed to ensure treatments were delivered in accordance with the dialysis prescriptions ordered by the physician for four (4) of four (4) CRs reviewed (CR#1, CR#2, CR#3 and CR#4). Findings included: Review of facility policy on 11/18/2024 at approximately 9:00 AM revealed: “Policy: 1-03-08, TITLE: Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment... PURPOSE: To obtain and document baseline and ongoing information about the patient before, during and after dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge... 3. Patient identity, prescription and machine settings re verified by teammate prior to initiation of treatment with exception of blood flow rate which is verified and documented when the order is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with nursing assessment...INTRADIALYTIC DATA COLLECTION ASSESSMENT... 9. Intradialytic monitoring and data collection which may be performed by the PCT or licensed nurse includes: a. vital signs and treatment monitoring...b. At a minimum, obtain and document the following:..iii. Blood and dialysate flows, arterial and venous pressures... 10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtained prescribed blood flow rate) the reason will be documented and the licensed nurse informed... 12. The licensed nurse notifies the physician as needed of changes in patient status. 13. All findings, interventions and patient response will be documented int the patient’s medical record... 16. If an abnormal finding(s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge... 17. Licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility...” Review of CRs conducted on 11/19/2024 from approximately 8:30 AM - 11:30 AM revealed the following: CR#1, admitted on 10/7/2024. Treatment flowsheets reviewed revealed: Treatment date: 10/28/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 10:30 AM - BFR 350ml/min documented by PCT; 11:00 AM - BFR 350ml/min documented by RN; 11:30 AM BFR 350ml/min documented by PCT, 12:00 PM - BFR 350ml/min documented by PCT; 12:30 PM - BFR 350ml/min documented by PCT; 13:00 PM - BFR 350ml/min documented by PCT; 13:30 PM - BFR 350ml/min documented by RN; 13:55 PM treatment terminated - BFR 350ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 10/30/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 10:44 AM - BFR 350ml/min documented by PCT; 10:56 AM - BFR 350ml/min documented by RN; 11:26 AM BFR 350ml/min documented by RN, 11:56 AM - BFR 350ml/min documented by RN; 12:26 PM - BFR 350ml/min documented by RN; 13:26 PM - BFR 350ml/min documented by RN; 13:56 PM - BFR 350ml/min documented by PCT; 14:12 PM treatment terminated - BFR 350ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/1/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 10:34 AM - BFR 350ml/min documented by RN; 11:04 AM - BFR 350ml/min documented by PCT; 11:31 AM BFR 350ml/min documented by RN, 12:01 PM - BFR 350ml/min documented by PCT; 12:31 PM - BFR 350ml/min documented by PCT; 13:01 PM - BFR 350ml/min documented by PCT; 13:31 PM - BFR 350ml/min documented by PCT; 14:01 PM - BFR 350ml/min documented by PCT; 14:05 PM treatment terminated - BFR 350ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/4/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 11:05 AM - BFR 350ml/min documented by PCT; 11:35 AM - BFR 350ml/min documented by PCT; 12:05 PM BFR 350ml/min documented by PCT, 12:32 PM - BFR 350ml/min documented by PCT; 13:02 PM - BFR 350ml/min documented by PCT; 13:32 PM - BFR 350ml/min documented by PCT; 14:02 PM - BFR 300ml/min documented by PCT; 14:32 PM - BFR 300ml/min documented by PCT; 14:35 PM treatment terminated - BFR 300ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/6/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 13:14 PM - BFR 350ml/min documented by PCT; 13:34 PM - BFR 350ml/min documented by RN; 14:04 PM BFR 350ml/min documented by PCT, 14:31 PM - BFR 350ml/min documented by PCT; 15:01 PM - BFR 350ml/min documented by PCT; 15:31 PM - BFR 300ml/min documented by PCT; 16:01 PM - BFR 300ml/min documented by PCT; 16:31 PM - BFR 300ml/min documented by RN; 16:41 PM treatment terminated. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/8/2024 - Blood Flow Rate (BFR) 250ml/min prescribed by physician; treatment initiated at 11:02 AM - BFR 350ml/min documented by PCT; 11:30 AM - BFR 350ml/min documented by PCT; 12:00 PM BFR 350ml/min documented by RN, 12:30 PM - BFR 350ml/min documented by RN; 13:00 PM - BFR 350ml/min documented by RN; 13:30 PM - BFR 350ml/min documented by PCT; 14:00 PM - BFR 350ml/min documented by RN; 14:30 PM - BFR 350ml/min documented by RN; 14:33 PM treatment terminated - BFR 350ml/min documented by RN. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/13/2024 - Dialysis Flow Rate (DFR) 800ml/min prescribed by physician; treatment initiated at 11:01 AM - DFR 800ml/min documented by PCT; 11:30 AM - DFR 300ml/min documented by RN; 12:00 PM - DFR 300ml/min documented by PCT, 12:30 PM - DFR 300ml/min documented by PCT; 13:00 PM - DFR 300ml/min documented by PCT; 13:30 PM - DFR 300ml/min documented by PCT; 14:00 PM - DFR 300ml/min documented by PCT; 14:30 PM- DFR 300ml/min documented by RN; 14:37 PM treatment terminated. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. CR#2, admitted on 1/11/2023. Treatment flowsheets reviewed revealed: Treatment date: 11/1/2024 - Blood Flow Rate (BFR) 400ml/min prescribed by physician; treatment initiated at 9:29 AM - BFR 400ml/min documented by PCT; 9:59 AM - BFR 400ml/min documented by RN; 10:01 AM BFR 360ml/min documented by RN, 10:31 AM - BFR 360ml/min documented by PCT; 11:01 AM - BFR 360ml/min documented by PCT; 11:31 AM - BFR 360ml/min documented by RN; 12:01 PM - BFR 360ml/min documented by PCT; 12:31 PM - BFR 360ml/min documented by RN; 13:02 PM treatment terminated - BFR 350ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/11/2024 - Blood Flow Rate (BFR) 400ml/min prescribed by physician; treatment initiated at 9:29 AM - BFR 450ml/min documented by PCT; 9:59 AM - BFR 450ml/min documented by RN; 10:33 AM BFR 450ml/min documented by PCT, 10:59 AM - BFR 450ml/min documented by PCT; 11:29 AM - BFR 450ml/min documented by RN; 11:59 AM - BFR 450ml/min documented by RN; 12:29 PM - BFR 450ml/min documented by RN; 12:59 PM treatment terminated - BFR 450ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/15/2024 - Blood Flow Rate (BFR) 400ml/min AND cannulation with 15 guage needles prescribed by physician; treatment initiated at 12:20 PM - PCT documented 16 guage needles used to cannulate and BFR 350ml/min documented by PCT; 13:00 PM - BFR 350ml/min documented by PCT; 13:30 PM BFR 350ml/min documented by PCT, 14:00 PM - BFR 350ml/min documented by PCT; 14:30 PM - BFR 350ml/min documented by PCT; 15:00 PM - BFR 350ml/min documented by RN; 15:09 PM - BFR 350ml/min documented by RN; 15:10 PM treatment terminated - BFR 350ml/min documented by RN. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. CR#3, admitted on 1/25/2023. Treatment flowsheets reviewed revealed: Treatment date: 11/1/2024 - Blood Flow Rate (BFR) 400ml/min prescribed by physician; treatment initiated at 11:17 AM - BFR 450ml/min documented by PCT; 11:30 AM - BFR 450ml/min documented by RN; 12:00 PM BFR 450ml/min documented by PCT, 12:30 PM - BFR 450ml/min documented by PCT; 13:00 PM - BFR 450ml/min documented by PCT; 13:30 PM - BFR 450ml/min documented by PCT; 14:00 PM - BFR 450ml/min documented by RN; 14:30 PM - treatment terminated - BFR 450ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. Treatment date: 11/6/2024 - Blood Flow Rate (BFR) 400ml/min prescribed by physician; treatment initiated at 11:23 AM - BFR 450ml/min documented by PCT; 11:36 AM - BFR 450ml/min documented by PCT; 12:00 PM BFR 450ml/min documented by RN, 12:30 PM - BFR 450ml/min documented by RN; 13:00 PM - BFR 450ml/min documented by PCT; 13:30 PM - BFR 450ml/min documented by RN; 14:00 PM - BFR 450ml/min documented by PCT; 14:30 PM - BFR 450ml/min documented by PCT; 14:38 PM - treatment terminated - BFR 150ml/min documented by PCT. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. CR#4, admitted on 8/28/2024. Treatment flowsheets reviewed revealed: Treatment date: 11/11/2024 - Blood Flow Rate (BFR) 350ml/min prescribed by physician; treatment initiated at 11:30 AM - BFR 200ml/min documented by PCT; 12:01 PM BFR 150ml/min documented by RN, 12:26 PM - treatment terminated - BFR 150ml/min documented by RN. Treatment sheet contained no evidence of RN notification to physician for inability to achieve/administer prescribed dialysis orders. An interview with the facility administrator on 11/19/2024 at approximately 2:30 PM confirmed the above findings.”

“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: 44820 Based upon a review of facility policy, review of facility policy, review of employee(EMP)/staff schedule, treatment area observations (OBS), and an interview with the Nurse and Facility Administrator, the Medical Director failed to ensure staff stored and secured facility medications per policy, for one (1) of two (1) observations (OBS #1). Findings include: A review on 11/18/2024 at approximately 2:45 PM of Incenter Hemodialysis Policies & Procedures Davita Inc. revealed: Procedure: “1-06-01” Title: “MEDICATION POLICY... PURPOSE: To provide guidancefor medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications... POLICY... 11. All refrigerated medications... are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate per state regulations...” A review on 11/19/2024 at approximately 9:00 AM of the facility staffing/employee schedule revealed no licensed personnel were scheduled to work on 11/19/2024. Observations conducted in patient treatment area on 11/19/2024 between approximately 11:30 AM -12:30 PM revealed the following: OBS #1 occurred on Tuesday, 11/19/2024, at approximately 12:20 PM revealed: medication preparation and storage drawers and medication refrigerator containing oral, intravenous and subcutaneous and sublingual medications were not locked or secured. An interview with the facility administrator conducted on 11/19/2024 at approximately 12:35 PM confirmed the above findings. “We only have patients scheduled on Monday’s, Wednesday’s and Friday’s, the medications should definitely be locked up at the end of business days on those days.””