Innovative Renal Care Ohio Valley Hospital

“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: 46886 Based on supply observations (OBS) and interviews with staff, the facility failed to monitor supplies and maintain a sanitary environment for one (1) of two (2) OBS periods. (OBS2) Findings include: Supply Management Observation #2 on 12/4/24 at approximately 11:50 am revealed patient isolation room contained six Luer lock caps Lot#20254 with an expiration date of 6/5/2022. The finding was reviewed on 12/4/24 at approximately 2:30 pm with EMP1 Facility Administrator.”

“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: 46886 Based on reviews of policies and medical records (MR) and interviews with staff (EMP), the facility failed to manage and monitor a patient ’ s treatments and fluid volume status for two (2) of four (4) MRs reviewed. (MRs 3&4) Findings included: A review of Charge Nurse Notification Protocol on 12/6/24 revealed: “ Events reportable to the nurse by Direct Patient Care Staff...Pretreatment Systolic Blood Pressure [greater than] 180 or [less than] 90 ...Pretreatment Cardiac Pulse [greater than] 110 or [less than] 55 ...Intradialytic [during treatment] Blood Pressure Systolic [greater than] 180 or [less than] 90 or any significant change in pressure ...Intradialytic Cardiac Pulse [greater than] 110 or [less than] 55...Posttreatment ... SBP (systolic blood pressure) [greater than] 180 or [less than] 110 Posttreatment Diastolic BP [greater than] 90 or [less than] 50 ...Always report any complaints or unusual signs and symptoms to the nurse and document that the nurse was notified. This Protocol is for Guidance, Please refer to your patient ’ s standing orders for further instructions ... “ A review of Patient Assessment: Pre & Post dialysis procedure on 12/6/24 revealed: “ To ensure patient safety at the end of the treatment to be released from the acute dialysis services unit ...Vital signs will include temperature, heart rate, and pre-and post-blood pressure on all patients ...Pre and Post dialysis assessments will include ...Mental status including level of consciousness, pain, ambulatory status...” A 12/3/24 review of MR3 ’ s HD Treatment Flowsheets (HTF) revealed: MR3: Admit date: 2/23/22. HTF dated 11/18/24 revealed Direct Patient Care Staff (DPCS) documented an intradialytic pressure of 192/114 but failed to document nurse notification as per facility policy. A post HD treatment pressure of 190/106 was documented prior to discharge and standing orders for post treatment discharge pressures were not available for review. HTF dated 11/20/24 revealed DPCS documented an intradialytic pressure of 200/113 but failed to document nurse notification as per facility policy. A post HD treatment pressure of 184/106 was documented prior to discharge and standing orders for post treatment discharge pressures were not available for review. HTF dated 11/22/24 revealed DPCS documented an intradialytic pressure of 191/109 but failed to document nurse notification as per facility policy. A post HD treatment pressure of 187/110 was documented prior to discharge and standing orders for post treatment discharge pressures were not available for review. HTF dated 11/29/24 revealed DPCS documented an intradialytic pressure of 191/120 but failed to document nurse notification as per facility policy. A post HD treatment pressure of 196/114 was documented prior to discharge and standing orders for post treatment discharge pressures were not available for review. A 12/3/24 review of MR4 ’ s HD Treatment Flowsheets (HTF) revealed: MR4: Admit date: 9/13/24. HTF dated 11/20/24 revealed a pre-treatment cardiac pulse of 50 and standing orders for pre-treatment cardiac pulse parameters were not available for review. During treatment, Direct Patient Care Staff (DPCS) documented cardiac pulse rates of 49 and 47 and failed to document nurse notification as per facility policy. Post treatment assessment documentation failed to reveal ambulatory status of MR4 as per facility policy. HTF dated 11/22/24 revealed a pre-treatment cardiac pulse of 52 and standing orders for pre-treatment cardiac pulse parameters were not available for review. During treatment, DPCS documented cardiac pulse rates of 44 and 46 and failed to document nurse notification as per facility policy. Post treatment assessment documentation failed to reveal ambulatory status of MR4 as per facility policy. HTF dated 11/25/24 revealed a pre-treatment cardiac pulse of 49 and standing orders for pre-treatment cardiac pulse parameters were not available for review. During treatment, DPCS documented cardiac pulse rates of 43, 46, and 46, but failed to document nurse notification as per facility policy. Post treatment assessment documentation failed to reveal ambulatory status of MR4 as per facility policy. HTF dated 11/29/24 revealed a pre-treatment cardiac pulse of 49 and standing orders for pre-treatment cardiac pulse parameters were not available for review. During treatment, DPCS documented a cardiac pulse of 43 but failed to document nurse notification as per facility policy. Post treatment assessment documentation failed to reveal ambulatory status of MR4 as per facility policy. The findings were reviewed with EMP1 facility administrator and EMP2 Clinical Regulatory Manager on 12/6/24 during an exit conference at approximately 2:00 pm.”

“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: 46886 Based on reviews of facility policy and medical records (MR), direct observations, and interviews with staff (EMP), the facility failed to ensure dialysis was administered as per prescription for one (1) of four (4) dialysis prescription observations (Observation 4) and three (3) of four (4) medical record reviews (MRs 1-3). Findings included: A review of Monitoring and Documentation of Patient Care During Treatment policy on 12/4/24 revealed: “ Purpose ...Data collected and documented accurately reflects what occurred during each dialysis treatment ...the following must be documented ...treatment Rx indicating caregiver review and verification of all patient treatment data and machine set-up information ...if the patient ’ s prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation ... “ Prescription Observation #4 (OBS4) conducted on 12/4/24 at approximately 11:45 am at Station #3 with EMP1 revealed a patient receiving a hemodialysis treatment with a Dialysate Flow Rate (DFR) of 800. A review of OBS4 ’ s hemodialysis prescription Current HD Order List obtained 12/4/24 at 10:50 am specified: “ ...Dialysate Flow rate: 500 ... “ Review of 12/4/24 HD Treatment Flowsheet (HTF) on 12/6/24 revealed a prescribed DFR = 500 was verified pre-treatment by RN and LPN, however DFR=800 was documented at 11:05, 11:31, and 11:35. Staff failed to correctly verify the patient ’ s prescription during treatment and failed to follow facility policy by dialyzing a patient with an incorrect DFR during OBS4. A review of MR1 on 12/3/24 revealed: MR1: Admit Date 8/2/22. MR1 contained HD Treatment Flowsheets (HTF) dated 8/26/24, 8/12/24, 8/16/24, 8/30/24, and 9/9/24 with Dialysis Prescriptions listing a Blood Flow Rate (BFR) of 350 and a Dialysate Flow Rate (DFR) of 500. HTF dated 8/12/24 documented a DFR=800, the facility failed to follow the physician ’ s order and provide the prescribed DFR of 500. HTF dated 8/16/24 documented BFR decreased to 275 approximately 90 minutes into the treatment and failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. HTF dated 8/26/24 documented BFR=300 and failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. HTF dated 8/30/24 documented BFR decreased to 280 approximately 45 minutes into the treatment and failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. HTF dated 9/9/24 documented a DFR=800 and a BFR decreased to 300 approximately 20 minutes into treatment. The 9/9/24 HTF failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy and the facility failed to follow the physician ’ s order and provide the prescribed DFR of 500. A review of MR2 on 12/3/24 revealed: MR2: Admit Date 8/15/22. MR2 contained HD Treatment Flowsheets (HTF) dated 11/15/24, 11/18/24, 11/20/24, 11/27/24, and 11/29/24 with a prescribed Blood Flow Rate (BFR) of 350. HTF dated 11/15/24 documented a BFR decreased to 260 approximately 10 minutes into the treatment and failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. HTF dated 11/18/24 documented a BFR decreased to 300 approximately 30 minutes into the treatment and failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. HTF dated 11/20/24 documented BFRs of 250 and 300 during the treatment, but failed to contain a progress note listing the reasons changes were made to the prescribed BFR as per facility policy. HTF dated 11/27/24 documented a BFR of 300 and failed to contain a progress note listing the reason for the change in a prescribed BFR as per facility policy. HTF dated 11/29/24 documented BFRs of 260 and 200 during the treatment, but failed to contain a progress note listing the reasons changes were made to the prescribed BFR as per facility policy. A review of MR3 on 12/3/24 revealed: MR3: Admit date: 2/23/22. MR3 contained HD Treatment Flowsheets (HTF) dated 11/18/24 11/20/24, 11/22/24, and 11/25/24 with a prescribed Blood Flow Rate (BFR) of 500. HTF dated 11/18/24 documented a BFR decrease to 450 approximately 30 minutes into the treatment but failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. HTF dated 11/20/24 documented a BFR 395-450 but failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. HTF dated 11/22/24 documented a BFR decrease to 450 approximately one hour into treatment but failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. HTF dated 11/25/24 documented a BFR of 450 but failed to contain a progress note listing the reason for a change in the prescribed BFR as per facility policy. The findings were reviewed with EMP1 facility administrator and EMP2 Clinical Regulatory Manager on 12/6/24 during an exit conference at approximately 2:00 pm.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 46886 Based on a review of policy, facility quality improvement data, dialysis facility reports and interviews with the administrator (EMP1) it was determined that the facility ’ s quality assurance performance improvement program (QAPI) failed to continuously monitor performance in the area of fluid management, specifically average ultrafiltration rates (UFR) greater than 13 ml/kg/hr affecting three (3) of thirty (30) hemodialysis patients. (MRs 3,5, and 6) Findings included: A review of scientific evidence published in the American Journal of Kidney Diseases revealed: “ ...ultrafiltration rates [greater than] 13 mL/h/kg were associated with greater mortality ...Findings were consistent across subgroups of sex, race, dialysis vintage, session duration, and body size. Higher ultrafiltration rates were associated with greater mortality when normalized to body weight, body mass index, and body surface area ... “ Assimon, M. M., Wenger, J.B., Wang, L., & Flythe, J. E. (2016, December) Ultrafiltration Rate and Mortality in Maintenance Hemodialysis Patients. American Journal of Kidney Diseases, 68(6), 911-922. https://doi.org/10.1002/mar.20105 An 11/18/24 review of the facility ’ s September 2024 Quarterly Dialysis Facility Report revealed 12.8 % of patients at the facility averaged an Ultrafiltration rate (UFR) greater than 13 ml/kg/hr between January-December 2023 while the national average for a UFR greater than 13 ml/kg/hr was 7.8 %, placing the facility above the national threshold and requiring a clinical outcome review during the scheduled recertification survey. A 12/2/24 interview with the facility administrator (EMP1) at approximately 10:00 am presented the September 2024 QDFR report information to the facility administrator and identified UFR rates greater than 13 ml/kg/hr as a focus of the recertification survey. ESRD Core Survey Data Worksheet completed on 12/2/24 by EMP1 identified three patients with a UFR greater than 13. A 12/6/24 QAPI review with EMP1, the facility administrator and QAPI coordinator, revealed that the facility did not currently track and trend or have a performance improvement plan related to patient average UFRs greater than 13. A 12/6/24 review of patient ’ s UFR averages between 9/6/24 - 12/6/24 revealed three patients [MR3, MR5, and MR6] with an average UFR greater than 13 ml/kg/hr. MR3 ’ s average UFR between 9/6/24-12/6/24 was 16.66. MR5 ’ s average UFR between 9/6/24-12/6/24 was 14.11. MR6 ’ s average UFR between 9/6/24-12/6/24 was 12.89. A 12/6/24 review of the Quality Assessment and Performance Improvement (QAPI) policy revealed: “ Purpose: To ensure that [care centers] regularly review outcome data to identify areas for improvement and take appropriate action to improve outcomes and processes ....The QAPI program must continually look at indicators for patients and associates as they are available ...trend outcomes...each [care center] must set priorities for performance improvement ...giving priority to improvement activities that affect clinical outcomes or patient safety. The following should be considered when determining priorities for improvement activities: ...impact on clinical outcomes ...patient safety ... “ While the facility reported a higher than national average clinical outcome between January-December 2023 and continued to identify individual patients with an elevated average UFR, the facility QAPI program failed to follow policy and continually identify, track, trend, and include a performance improvement plan related to UFR averages greater than 13 ml/kg/hr, a CMS identified clinical outcome threshold associated with a higher rate of patient mortality. The findings were reviewed with EMP1 facility administrator and EMP2 Clinical Regulatory Manager on 12/6/24 during an exit conference at approximately 2:00 pm.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 31759 Based on review of facility policy, manufacturer’s directions for use, observation, and staff (EMP) interview, the facility failed to follow written protocols for the cleaning and disinfection of contaminated surfaces, medical devices, and equipment for one (1) of one (1) bleach mixture (bleach 1). Findings include: Review of facility policy on May 1, 2024, at 12:30 p.m. showed, “G45 Cleaning and Disinfection of Equipment, Supplies & Treatment Area ... POLICY: 1. Unless equipment manufacturer’s specify use of another agent, equipment will be disinfected using 1:100 bleach/water solution.” Review of “pHoenix XL User Guide Rev. F” that was available for review where the meter’s where stored on treatment floor on April 30, 2024, at 11 a.m. showed, “Disinfecting Recommendations ... we recommend that you follow these steps daily before the first use of the meter: 1. Draw 1% bleach solution (one-part bleach to ninety-nine parts dialysis quality water) mixed fresh daily, into the meter to the 10 ml line. ... Let the solution sit in the meter for approximately for approximately 10 minutes. ... CAUTION: ... Dwell times longer than 10 minutes will cause premature deterioration of the Measurement Module.” Observation on the treatment floor on May 1, 2024, at 10 a.m. revealed three pHoenix meters (used to test dialysate conductivity) located on counter next to the sink. Also at the counter were two small bins of a water/bleach mixture used to wipe surfaces and to dwell inside equipment such as the pHoenix meter. During interview with EMP3 on May 1, 2024, at 10:10 a.m. he/she confirmed the two bins observed on the sink’s counter contained a mixture of bleach and water. EMP3 confirmed the bleach is used for disinfecting surfaces, and that it was used inside the pHoenix meters today before the treatment day started, where it dwelled for 10 minutes. Surveyor asked EMP3 to describe the process for making the bleach water mixture. EMP3 showed surveyor a 5-liter (5000 milliliter) pitcher that the bleach and water are mixed in. The pitcher had two lines drawn on it with a felt-tip marker. One line was loosely drawn at the pitcher’s 3000-milliliter mark, and another was loosely drawn over the pitcher’s 2900-liter mark. EMP3 noted that he/she fills the pitcher with 2900 liters of RO (dialysate quality) water and then adds full strength bleach (100 ml) until the total volume of bleach and water is 3000 milliliters. Interview with EMP1 (clinic manager) on May 1, 2024, at 12 p.m. confirmed above findings and that the above mixture is not 100:1 bleach but actually 29:1.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 31759 Based on review of facility policy, observation, and staff (EMP) interview, the facility failed to operate pHoenix XL meters (dialysis equipment for verifying conductivity) in accordance with the manufacturer’s directions for use for three (3) of three (3) Phoenix meters (PXH23501, PXH23499, & PXH27265). Findings included: Observation of treatment floor during a non-treatment day on April 30, 2024, at 10:20 a.m. revealed the facility’s three pHoenix XL meters (PXH23501, PXH23499, & PXH27265) were stored with 8-9 milliliters (ml) of liquid inside the meter’s control syringe (20 ml syringe for holding sample to be tested). Interview with EMP2 (technical manager) at 10:42 a.m. confirmed the meter’s syringes contained Neocare and have been stored this way since end-of-treatment day on 4/29/2024. See below for manufacturer’s recommendations on storage-- meters are not to be stored with Neocare. Review of maintenance logs “ARA Dialysis Ohio Valley Phoenix Meter XL Verification and Calibration Log” on April 30, 2024, at 10:53 a.m. showed that the meters required calibration on 4/8, 4/10, and 4/12/2024. On 4/8, the meter’s (PXH23501) verified conductivity was 14.2 with no recalibration. On 4/10, the meter’s (PXH23501) verified pH was 7.2 with no recalibration. On 4/12, the meter’s (PXH27265) verified conductivity was 14.2 with no recalibration. Per directions on the maintenance log, conductivity must be 14.0 +/- 0.1 or 13.9-14.1, and pH must be 7.0 +/- 0.1 or 6.9-7.1. Review of “pHoenix XL User Guide Rev. F” that was available for review where the meter’s were stored on treatment floor on April 30, 2024, at 11 a.m. showed, “B. Safety Cautions Verify accurate function of your pHoenix Meter before taking measurements or whenever inaccurate readings are suspected. ... Disinfecting Recommendations ... we recommend that you follow these steps daily before the first use of the meter: 1. Draw 1% bleach solution (one-part bleach to ninety-nine parts dialysis quality water) mixed fresh daily, into the meter to the 10 ml line. ... Let the solution sit in the meter for approximately for approximately 10 minutes. ... CAUTION: ... Dwell times longer than 10 minutes will cause premature deterioration of the Measurement Module. ... Storage Recommendations ... Mesa Laboratories NEO-CARE Cleaning Solution is ideal for pHoenix XL Meter. For storing meters overnight ot long, follow these steps: 1. Flush the meter with ... NEO-CARE ... 2. Disconnect the meter from the solution. Purge remaining fluid by rapidly pumping the syringe several times into waste receptacle. 3. Seal the Measurement module with an air-tight cap. 4. The measurement module is to be damp only during storage, never full of fluid. Always seal the measurement module to prevent residual NEO-CARE in the cell and syringe from drying out.” Note: facility used a stronger concentration of bleach in their meters. See V122 for more information. An interview with EMP2 on April 30, 2024, at approximately 1 p.m. confirmed above findings concerning calibration and that the pHoenix meters are not to be stored with Neocare inside the syringe (to be expelled leaving residual only to maintain dampness).”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 31759 Based on review of National Kidney Foundation (NKF) Guidelines, observation (OBS), and staff (EMP) interview, the facility failed to ensure one (1) of one (1) patient with an arteriovenous fistula (AVF) washed their access prior to disinfection and initiation of dialysis (AVF1). Findings included: According to NKF Guidelines, “Tips for Everyday Care of Your AV Fistula or Graft Prevent Infection ... Wash your access site before every dialysis treatment. Your dialysis center has hand washing sinks and antimicrobial soap.” Retreived from https://www.kidney.org/sites/default/files/11-50-0216_va.pdf Observation (AVF1) on treatment floor during initiation of dialysis on May 1, 2024, a 12 p.m., revealed patient ambulate to station 10 without washing his/her access at the sink. EMP1 wiped patient’s access with disinfectant, inserted needles into patient’s access, and started dialysis treatment. Interview with EMP1 at 12:05 p.m. confirmed patient did not wash his/her access in sink with soap and water prior to initiation of dialysis. EMP1 noted that he/she wiped AVF1’s access with a hand-sanitizing wipe (PDI Sani-Hands Instant Hand Sanitizing Wipes) per facility policy. When EMP1 was asked why the patient did not wash his/her access in sink EMP1 noted that the patient refuses to do so. Surveyor requested that EMP1 provide documentation from patient’s clinical record that he/she had been refusing to wash his/her access in the sink. EMP1 was unable to provide prior documentaiton that to show the patient had been refusing to wash his/her access in the sink or that the patient was educated concerning this guideline. EMP1 asserted that he/she did however document that patient refused to wash his/her access in the sink for today’s treatment. Interview with the patient while he/she was on dialysis on May 1, 2024, at 12:25 p.m. did not reveal that he/she refused to wash his/her access in the sink or that he/she was opposed to this practice.”