Rai Lebanon

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 40606 Based on review of the facility policy, review the facility’s evidence-based algorithm for fluid management and anemia management and interview, the Medical Director (MD) and Interdisciplinary Team (IDT) failed to address monthly clinical outcomes for 2 patients (#1 and #5) of 6 patients reviewed. This failure had the potential to affect all patients receiving care and services. This failure resulted in the Condition of Coverage (494.80) Patient Assessment not met. The findings include: V 504 - Based on review of the facility’s policies and procedures, review the facility’s evidence-based algorithm for fluid management, medical record review and interview, the facility failed to address fluid management needs for 2 patients (#1 and #5) of 6 patients reviewed for fluid management. V 507 - Based on review of the facility’s policies and procedures, review the facility’s evidence-based algorithm for anemia management, medical record review and interview, the facility failed to address the anemia management needs for 3 patients (#1, #2, and #5) of 6 patients reviewed for anemia management. Refer to V 504 and V 507.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 40606 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) meeting minutes, review of the facility’s census monthly lab documentation, review of the facility’s policies and procedures and interview, the facility’s QAPI Program and its members failed to act with operational responsibility to create and implement interventions to improve clinical outcomes for the facility’s patients. This failure resulted in the Condition of Coverage (494.110); Quality Assessment and Performance Improvement not met. The findings include: V 629 - Based on review of the Quality Management General Policy, review of the facility’s percentage of patients not meeting dialysis adequacy, fluid management standards, or anemia management protocols, review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes and interview, the facility’s QAPI committee, led by the Medical Director, failed to conduct comprehensive assessments of patients’ needs and develop Action Plans in response to the monthly clinical quality outcomes reviewed by the QAPI committee. Refer to V 629.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 40606 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) meeting minutes, review of the facility’s policies and procedures and interview, the Medical Director failed to ensure the quality of patient care and clinical outcomes. This failure had the potential to affect all patients receiving care and services. This failure resulted in the Condition of Coverage (494.150) Responsibilities of the Medical Director not met. V 712 - Based on review of the Quality Management General Policy, review of the facility’s percentage of patients not meeting adequacy, review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes and interview, the facility’s Medical Director failed to act with operational responsibility for the QAPI program. This failure had the potential to affect 59 patients receiving patient care. V 715 - Based on review of the facility’s Quality Management General Policy and interview, the facility’s Medical Director failed to uphold the Quality Management General Policy related to the assessment of patients’ response to the dialysis dose ordered; failed to provide a plan to address continuously low monthly dialysis quality indicators; failed to provide a plan to reflect evidence based professional patient safety standards related to patients’ response to the dose of dialysis prescribed and failed to develop a plan for the facility to offer additional treatment days. The provision of extra dialysis treatments would provide an opportunity for patients related to dialysis adequacy and fluid volume status management. These failures had the potential to impact all patients on the census. Refer to V 712 and V 715.”

“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: 40606 Based on review of the facility’s policies and procedures, review the facility’s evidence-based algorithm for fluid management, medical record review, and interview, the facility failed to address fluid management needs for 2 patients (#1 and #5) of 6 patients reviewed for fluid management. The findings include: Review of the facility policy titled Routine Dialysis Procedures, undated, showed “...Assess the patient’s Fluid Volume Status...Compare the weight to the patient’s dry weight and last post-dialysis weight...Notify the NP [Nurse Practitioner]...unless other parameters are ordered specific to the patient...Does the patient need to be scheduled for an extra HD [hemodialysis]...Notify the NP...If the EDW [estimated dry weight/weight without excessive fluid that builds up between dialysis] needs to be adjusted...If the planned post treatment weight is < [less than] or > 1 Kg [kilogram=2.2 pounds] of the ordered EDW...” Medical record review showed Patient #1 was admitted to the facility on 5/20/2024 for incenter hemodialysis with diagnoses including Encounter for Adequacy Testing for Hemodialysis, Chronic Respiratory Failure, and Dependence on Renal Dialysis. Medical record review of Patient #1’s physicians orders showed Patient #5 had an EDW of 136 and a treatment time of 3 hours and 15 minutes. Review of Patient #1’s Care Plan dated 8/27/2024 showed “...Area of Focus...BLOOD PRESSURE & FLUID MANAGEMENT...Goal...Achieve BP Control as specified by the patient’s physician...Intervention(s)...Educate patient...on fluid control (6/13/2024)...Change patient’s dry weight (algorithm or MD order)...in progress...8/26/2024). Further review of the care plan showed the following: Date EDW(Kg) Post Weight(Kg) Amount over EDW (Kg) patient left facility 8/26/2024 63.2 65.6 2.4 8/23/2024 63.2 65.9 2.7 8/19/2024 63.2 67.0 3.8 8/12/2024 63.2 67.0 3.8 8/9/2024 63.2 66.0 2.8 8/5/2024 63.2 67.0 3.8 Medical record review of Patient #1’s hemodialysis flowsheets from 8/30/2024 through 9/23/2024, showed the patient’s EDW of 63.2 and the following post treatment weights: - On 8/30/2024 the patient’s post treatment weight was 65.6 kg (2.4 kg > [greater than] EDW). - 9/2/2024 the patient’s post treatment weight was 65.7 kg (2.5 > EDW). - 9/6/2024 the patient’s post treatment weight was 67.1 kg (3.9 kg > EDW). - 9/9/2024 the patient’s post treatment weight was 66.5 kg (3.3 kg > EDW). - 9/13/2024 the patient’s post treatment weight was 67.8 kg (4.6 kg > EDW). - 9/16/2024 the patient’s post treatment weight was 68.2 kg (5.0 kg > EDW). - 9/21/2024 the patient’s EDW was increased to 68 Kg (4.8 Kg difference from previous EDW) the post treatment weight was 67.5 kg (.5 kg < EDW). - 9/23/2024 the patient’s post treatment weight was 68.8 kg (.8 kg > EDW). Further review showed no documentation of any further intervention(s) implemented to address Patient #1’s volume status. Patient #5 was admitted to the facility on 12/2/2024 with diagnoses including End Stage Renal Disease, Chronic Obstructive Pulmonary Disease and Fluid Overload. Review of Patient #5’s Care Plan dated 9/17/2024 showed “...Area of Focus...BLOOD PRESSURE & FLUID MANAGEMENT...Goal...Achieve BP Control as specified by the patient’s physician...Intervention(s)...Educate patient...on fluid control (6/13/2024)...Change patient’s dry weight (algorithm or MD order)...in progress...8/26/2024). Medical record review of Patient #5’s hemodialysis flowsheets dated 9/4/2024 through 9/23/2024, showed the patient’s EDW was 136 kg and the following post treatment weights: - 9/4/2024 the patient’s post treatment weight was 137.7 kg (1.7 kg > EDW) ); no extra time or fluid removal ordered. - 9/6/2024 the patient’s post treatment weight was 138.2 kg (2.2 kg > EDW); no extra time or fluid removal ordered. - 9/9/2024 the patient’s post treatment weight was 137.7 kg (1.7 kg > EDW); note was documented to remove 0.2 Kg below EDW, did not remove fluid as directed. - 9/11/2024 the patient’s post treatment weight was 136.9 kg (0.9 kg > EDW); note was documented to remove 0.2 Kg below EDW, did not remove fluid as directed. - 9/13/2024 the patient’s post treatment weight was 137.6 kg (1.6 kg > EDW); Patient signed off 30 minutes early. The patients pre weight was 139.2 Kg. - 9/16/2024 the patient’s post treatment weight was 136.1 kg (0.1 kg > EDW); note was documented to remove 0.2 Kg below EDW, did not remove fluid as directed. - 9/18/2022 the patient’s post treatment weight was 136.7 kg (0.7 kg > EDW); the patient documentation showed fluid was not removed from 11:36 AM to 12:05 PM, no documentation why fluid was not removed for that time. - 9/20/2024 patient missed treatment. - 9/23/2024 the patient’s post treatment weight was 136.6 kg (0.6 kg > EDW). Further review showed no documentation of any intervention implemented to address Patient #5’s volume status. During an interview on 9/26/2024 at 12:05 PM, the Director of Operations (DO) confirmed the increased percentage of patients not meeting fluid volume management adequacy had increased, missed treatments, and re/hospitalizations in the clinic were issues. During an interview on 9/27/2022 at 10:45 AM, the Medical Director (MD) stated he was responsible for the day-to-day operation of the dialysis facility and responsible for the clinical outcomes of the patients who receive dialysis treatments at this facility. Continued interview revealed the Medical Director was aware of the patients not meeting quality indicators, he stated, “...I know quality is low...” Continued interview revealed when he was asked about any attempts to improve the fluid management in the facility, he could not voice current interventions the facility had discussed or implemented. The Medical Director could not answer as to why patients were not offered extra treatments or other interventions to improve fluid status.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 40606 Based on review of the facility’s policies and procedures, review the facility’s evidence-based algorithm for anemia management, medical record review and interview, the facility failed to address the anemia management needs for 3 patients (#1, #2, and #5) of 6 patients reviewed for anemia management. The findings include: Review of the Medical Director Compliance Guidelines, Version 3 revised 1/1/2007, and review of the Medical Director Services Handbook, undated, showed the QAPI committee members, (to include Physician/Medicap Director) should perform ongoing assessment of data as it is related to clinical outcomes. The interdisciplinary team is to assess and identify commonalities among a clinics’ patient population who are not meeting the minimum expected targets (i.e. quality indicator goals) and implement interventions to improve quality indicator goals. If quality indicator goals are not met, the previously developed plan or intervention should be reevaluated for its effectiveness. The physician/Medical Director should develop, implement, and evaluate patients’ quality indicator goals by the use of widely accepted community-developed standards. The Centers for Medicare and Medicaid Services (CMS)-Clinical Performance Measures (CPMs), National Kidney Foundation (NKF), and Kidney Disease Outcomes Quality Initiative (KDOQI) are entities who have developed evidence based, minimum outcome criteria for dialysis facility’s to adopt as quality measure values to identify opportunities to improve care. Based on review of the facility’s algorithm titled, “...Corporate...Recommended Anemia Algorithm [name of medication] IVP [intravenous push] Administration (In Center Only)...” dated 1/1/2023, showed “...[name of medication] Starting Dose Chart...Use patient’s post weight to determine starting dose. If post weight is unavailable, use...estimated dry weight...Rounded Weight (kg) [kilograms]...Dose...(mcg) [micrograms]...Every 2 weeks...” Medical record review showed Patient #1 was admitted to the facility on 5/20/2024 for incenter hemodialysis with diagnoses including Chronic Respiratory Failure and Dependence on Renal Dialysis (End Stage Renal Disease). Medical record review of Patient #1’s physician’s progress note dated 5/20/2024, showed “...Clinical Notes...reviewed labs...discussed with patient...anemia...” There was no specific goal for the hemoglobin target range or numerical value identified in the note by the physician. The physician did not address the patient’s anemia status in the note. Medical record review of Patient #1’s physician’s progress note dated 6/17/2024, showed “...Clinical Notes...reviewed labs...discussed with patient...anemia...Hb last month 9.2...increase [ESA name] to 150 mcg every 2 weeks until labs are back...” There was no specific goal for the hemoglobin target range or numerical value identified in the note by the physician. Medical record review of Patient #1’s physicians’ progress note dated 7/19/2024 showed “...Clinical Notes...reviewed labs...discussed with patient...anemia...Hb 10.9...reduce [ESA name] 200 mcg every 2 weeks and continue to decrease as needed...” There was no specific goal for the hemoglobin target range or numerical value identified in the note by the physician. Medical record review of Patient #1’s physicians’ progress note dated 8/9/2024 showed no reference to assessment of anemia in the note. Patient #2 was admitted to the facility on 3/29/2021 with diagnoses including End Stage Renal Disease, Fluid Overload, Anemia and Chest Pain. Medical record review of a physicians’ progress note dated 5/17/2024, showed”...Clinical Notes...reviewed labs...discussed with patient...anemia...Hb [hemoglobin-part of blood that aids in carrying oxygen] 7.1 [range-the minimum quality indicator goal is 10]...increase ESA[name]...[ESA-Erythropoietin Stimulating Agent is a medication used to treat low blood counts.] to 20,000 units [maximum dose] per treatment and as hemoglobin starts climbing reduce the dose...multiple hospitalizations...” Refer above to facility algorithm and note the corporation had made conversion charts to reference one another for dosing information. Medical record review of a physicians’ progress note dated 6/12/2024 showed”...Clinical Notes...reviewed labs...discussed with patient...anemia...Hb 9.7...[ESA name] at max dose and at some point will need to reduce it if hemoglobin continues to rise...” There was no specific goal for the hemoglobin target range or numerical value identified in the note by the physician. Medical record review of a physicians’ progress note dated 7/5/2024 showed “...Clinical Notes: Continue dialysis as prescribed...Clinically stable...” Nothing was documented by the physician that addressed the quality indicator goal of Hb of 9.7 as of the 6/12/2024 visit or interventions to manage the patients anemia. Medical record review of a physicians’ progress note dated 8/14/2024 showed”...Clinical Notes...reviewed labs...discussed with patient...anemia...Hb 10.3...increase [ESA name] to 17,000 units...” There was no specific goal for the hemoglobin target range or numerical value identified in the note, the previous note indicated patient was ordered the maximum dose of 20,000 units of an ESA. Medical record review of a physicians’ progress note dated 9/18/2024 showed “...Clinical Notes: Continue dialysis as prescribed...Clinically stable...” Nothing was documented by the provider that addressed the patients anemia status. Patient #5 was admitted to the facility on 12/2/2024 with diagnoses including End Stage Renal Disease, Chronic Obstructive Pulmonary Disease, Fluid Overload, and Cocaine Abuse. Review of the medical record showed Patient #5’s current care plan identified the area of focus of anemia management. The intervention implemented for the patient was “...Monitor HGB [hemoglobin]...Change ESA dose (MD/per algorithm)...” There was no specific goal for the hemoglobin target range or numerical value identified. Medical record review of Patient #5’s physicians’ progress note dated 6/17/2024 showed”...Assessment...Anemia...Follow Anemia protocol...” There was no specific goal for the hemoglobin target range or numerical value identified in the note by the physician. Medical record review of Patient #5’s physicians’ progress note dated 7/19/2024 showed”...Clinical Notes...reviewed labs...discussed with patient...anemia...Hb 8.9...[ESA name] to 100mcg every 2 weeks...” There was no specific goal for the hemoglobin target range or numerical value identified in the note, the previous note indicated patient was ordered “follow anemia protocol.” Medical record review of Patient #5’s physicians’ progress note dated 8/16/2024 showed”...Clinical Notes...reviewed labs...discussed with patient...anemia...Hb 9.9...[ESA name] at current dose...” There was no specific goal for the hemoglobin target range or numerical value identified in the note. Medical record review of Patient #5’s physicians’ progress note dated 9/16/2024 showed”...Clinical Notes...reviewed labs...discussed with patient...anemia...Hb 11.1...Continue [ESA name] per protocol...” There was no specific goal for the hemoglobin target range or numerical value identified in the note. Review of facility documentation of lab results for Patient #5 showed the following: Date Hemoglobin result (with the Goal range of 10-12) 7/3/2024 9.4 7/10/2024 8.9 7/26/2024 9.7 7/31/2024 9.3 8/7/2024 9.9 Review of quality indicator documentation provided by the facility, showed the clinical outcomes/quality indicator for anemia in 9/2024 showed 40.9 % of the facility’s patient population with a hemoglobin result of less than 10. Therefore, 24 of the 59 patients were below the minimum value range of the target indicator (NOTE: This range allows the ESRD patients to have increased energy related to oxygen delivery to their body’s cells). During an interview on 9/26/2024 at 12:05 PM, the Director of Operations (DO) confirmed the increased percentage of patients not meeting anemia management adequacy had increased. During an interview on 9/27/2024 at 10:45 AM, the Medical Director (MD) stated he was responsible for the day-to-day operation of the dialysis facility and responsible for the clinical outcomes of the patients who receive dialysis treatments at this facility. The continued interview revealed the Medical Director was aware of the patients not meeting quality indicators, he stated, “...I know quality is low...” Continued interview revealed, when asked about the attempted to improve anemia management in the facility, he could not voice current interventions the facility’s had implemented. When asked why patients with low anemia quality indicator markers were not offered ESA medication per the corporations’ protocol, the Medical Director stated “...I know my patients...they are sick...the algorithms don’t take into consideration how sick they are...””

“QAPI-INDICATOR-ADEQUACY OF DIALYSIS CFR(s): 494.110(a)(2)(i) The program must include, but not be limited to, the following: (i) Adequacy of dialysis. This Standard is not met as evidenced by: 40606 Based on review of the Quality Management General Policy, review of the facility’s percentage of patients not meeting dialysis adequacy, fluid management standards, or anemia management protocols, review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes and interview, the facility’s QAPI committee, led by the Medical Director, failed to conduct comprehensive assessments of patients’ needs and develop Action Plans in response to the monthly clinical quality outcomes reviewed by the QAPI committee. The finding include: Review of the Quality Management General Policy, revised 4/6/2011, showed “...Quality Management Committee develops, implements and maintains effective data driven assessment and performance improvement activities...The activities reflect the complexity of dialysis facility’s organization and focuses on indicators [of quality measures] related to positive health outcomes...” The QAPI committee members should perform ongoing assessment of data as it is related to clinical outcomes. The interdisciplinary team is to assess and identify commonalities among a clinics’ patient population who are not meeting the minimum expected targets (i.e. quality indicator goals) and implement interventions to improve quality indicator goals. If quality indicator goals are not met, the previously developed plan or intervention should be reevaluated for its effectiveness. The QAPI committee should develop, implement, and evaluate patients’ quality indicator goals by use widely accepted community-developed standards. The Centers for Medicare and Medicaid Services (CMS)-Clinical Performance Measures (CPMs), National Kidney Foundation (NKF), Kidney Disease Outcomes Quality Initiative (KDOQI), and the Association for the Advancement of Medical Instrumentation (AAMI) are entities who have developed evidence based, minimum outcome criteria for dialysis facility’s to adopt as quality measure values to identify opportunities to improve care. Review of the QAPI meeting minutes for April 2024-September 2024 showed the facility included monthly assessment of Adequacy. Continued review showed the adequacy measurements included the percentage (%) of patients not meeting the following goals: 1) Kt/V < 1.2 (a monthly measurement of dialysis adequacy, obtained from patients’ bloodwork that reflects how efficiently toxins are removed on the dose of dialysis prescribed). 2) Missed treatments (1 or more missed dialysis treatments each month). 3) Fluid Volume status (indicator of excessive fluid retention). 4) Hospitalizations Further review of the QAPI meeting minutes showed for the prior 5 months, in relation to the survey conducted in September 2024 (QAPI data lags 1 month behind) an average of 13.1% of the facility’s patients did not meet the monthly dialysis adequacy Kt/V goal. During this 5-month period, there was an average of 11% of the patient population not meeting the dialysis adequacy goal of Kt/V of 1.2. Continued review of the QAPI meeting minutes revealed for the prior 5 months, in relation to the survey conducted in September 2024 (data is 1 month behind) an average of 39% of the facility’s patients did not meet the monthly “missed treatment” goal. Continued review of the QAPI meeting minutes revealed for the prior 5 months, in relation to the survey conducted in September 2024, an average of 44.3% of the facility’s patients did not meet established fluid volume management parameters. The fluid volume status (Estimated Dry Weight-EDW) is established by the Nephrologist using kilograms (kg). The unit of measure of 1 kg. (1 kg. = 34 fluid ounces = 2.2 pounds) as the preferred unit of measure. The EDW is referred to as a baseline weight to establish safe fluid removal (not having symptoms) as a result of removal of too much fluid removed during the dialysis treatment process. Dialysis patients are advised by their Nephrologist and their care team to limit fluid intake to 1 kg. per day between dialysis treatments. Further monthly review showed the following: -April 2024- percentage of patients not meeting the monthly fluid volume management parameter was 45.2%, -May 2024- percentage increased to 48.8%, -June 2024- percentage of patients not meeting the fluid volume management parameter at 40.5%, -July 2024- percentage increased to 43.2%, -August 2024- percentage of patients not meeting fluid volume management parameters increased to 44%. During an interview on 9/26/2024 at 12:05 PM, the Director of Operations (DO) confirmed the percentage of patients not receiving adequate dialysis treatments had increased, inadequate fluid volume management continued for greater than 40% of the patients, missed treatments and re-hospitalizations identified by QAPI data remained quality indicator issues. During an interview on 9/27/2022 at 10:45 AM, the Medical Director (MD) confirmed patients’ who have not met quality indicators were reviewed monthly in the QAPI meetings. The Medical Director, when asked about the work that the QAPI committee had attempted to improve the clinical outcomes in the facility, he could not voice current interventions the facility’s had discussed or implemented for improving quality indicators in the clinic as a whole.”

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 40606 Based on review of the Quality Management General Policy, review of the facility’s percentage of patients not meeting adequacy, review of the Quarterly Update of the Dialysis Facility Report June 2024, review of the Quality Assessment and Performance Improvement (QAPI) meeting minutes and interview, the facility’s Medical Director failed to act with operational responsibility for the QAPI program. This failure had the potential to affect all patients on the census. The findings include: Review of the Quality Management General Policy, revised 4/6/2011, showed “...Quality Management Committee develops, implements and maintains effective data driven assessment and performance improvement activities...The activities reflect the complexity of dialysis facility’s organization and focuses on indicators related to positive health outcomes...” Review of the QAPI meeting minutes for April 2024-September 2024 showed the facility included monthly assessment of “Adequacy.” Continued review showed the adequacy measurements included the percentage (%) of patients not meeting the following goals: 1) Kt/V < 1.2 (a monthly bloodwork measurement of adequate clearance of waste products from the patient’s blood obtained with the dose of dialysis prescribed) 2) Missed treatments (1 or more missed dialysis treatments each month) 3) Fluid Volume status (indicator of excessive fluid retention) 4) Hospitalizations Further review of the QAPI meeting minutes showed for the prior 5 months, in relation to the survey conducted in September 2024 (QAPI data lags 1 month behind) an average of 13.1% of the facility’s patients did not meet the monthly Kt/V goal. Further monthly review showed the following: April 2024- percentage of patients not meeting the Kt/V goal was 10.3%, May 2024- percentage decreased to 5.1%, June 2024- percentage of patients not meeting the goal increased to 15.6%, July 2024- percentage decreased to 11.9%, August 2024- percentage of patients not meeting the goal was 12.2%. During this 5-month period, there was an average of 11% of the patient population not meeting the goal of Kt/V of 1.2. Continued review of the QAPI meeting minutes revealed for the prior 5 months, in relation to the survey conducted in September 2024 (data is 1 month behind) an average of 39% of the facility’s patients did not meet the monthly missed treatment goal. The goal for the cumulative dialysis clinics of the corporation was 24%. Continued review of the QAPI meeting minutes revealed for the prior 5 months, in relation to the survey conducted in September 2024, an average of 44.3% of the facility’s patients did not meet the monthly fluid volume management goal (what was the goal?). Further monthly review showed the following: April 2024- percentage of patients not meeting the monthly fluid volume management goal was 45.2%, May 2024- percentage increased to 48.8%, June 2024- percentage of patients not meeting the goal at 40.5%, July 2024- percentage increased to 43.2%, August 2024- percentage of patients not meeting the fluid volume management goal was 44%. During an interview on 9/26/2024 at 12:05 PM, the Director of Operations (DO) confirmed the percentage of patients not receiving adequate dialysis treatments had increased, inadequate fluid volume management continued for greater than 40% of the patients, missed treatments and re-hospitalizations remained quality issues. During an interview on 9/27/2022 at 10:45 AM, the Medical Director stated he was responsible for the day-to-day operation of the dialysis facility and responsible for the clinical outcomes of the patients who receive dialysis treatments at this facility. Continued interview revealed the Medical Director was aware of the patients not meeting adequacy and other quality indicators, he stated “...I know quality is low...””

“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: 40606 Based on review of the facility’s Quality Management General Policy and interview, the facility’s Medical Director failed to uphold the Quality Management General Policy related to the assessment of patients’ response to the dialysis dose ordered; failed to provide a plan to address continuously low monthly dialysis quality indicators; failed to provide a plan to reflect evidence based professional patient safety standards related to patients’ response to the dose of dialysis prescribed and failed to develop a plan for the facility to offer additional treatment days. The provision of extra dialysis treatments would provide an opportunity for patients related to dialysis adequacy and fluid volume status management. These failures had the potential to impact all patients on the census. The findings include: Review of the Quality Management General Policy, revised 4/6/2011, showed “...Quality Management Committee develops, implements and maintains effective data driven assessment and performance improvement activities...The activities reflect the complexity of dialysis facility’s organization and focuses on indicators [of quality measures] related to positive health outcomes...” The Medical Director should act with responsibility and in conjunction with QAPI committee members to perform prioritization of ongoing assessment(s) of data as it is related to clinical quality outcomes. The interdisciplinary team is to assess and identify commonalities among a clinics’ patient population who are not meeting the minimum expected targets (i.e. quality indicator goals) and implement interventions to improve quality indicator goals. If quality indicator goals are not met, the previously developed plan or intervention should be reevaluated for its effectiveness. The Medical Director in conjunction with QAPI committee should evaluate patients’ quality indicator goals, develop, implement a plan(s) by implementing widely accepted community-developed standards relative to the unique patient population served by the facility. The Centers for Medicare and Medicaid Services (CMS)-Clinical Performance Measures (CPMs), National Kidney Foundation (NKF), Kidney Disease Outcomes Quality Initiative (KDOQI), and the Association for the Advancement of Medical Instrumentation (AAMI) are entities who have developed evidence based, minimum outcome criteria for dialysis facility’s to adopt as quality measure values to identify opportunities to improve care. Review of the QAPI meeting minutes for April 2024-September 2024 showed the facility included monthly assessment of Adequacy. Continued review showed the adequacy measurements included the percentage (%) of patients not meeting the following goals: 1. Kt/V < 1.2 (a minimum monthly measurement of dialysis adequacy, obtained from patients’ bloodwork that reflects how the patient responds to the dose of dialysis prescribed by the physician). 2. Missed treatments (1 or more missed dialysis treatments each month). 3. Fluid Volume status (indicator of excessive fluid retention). 4. Hospitalization/Readmissions Further review of the QAPI meeting minutes showed for the prior 5 months, in relation to the survey conducted in September 2024 (QAPI data lags 1 month behind) an average of 13.1% of the facility’s patients did not meet the monthly dialysis adequacy Kt/V goal. During this 5-month period, there was an average of 11% of the patient population not meeting the dialysis adequacy goal of Kt/V of 1.2. Continued review of the QAPI meeting minutes revealed for the prior 5 months, in relation to the survey conducted in September 2024 (data is 1 month behind) an average of 39% of the facility’s patients did not meet the monthly “missed treatment” goal. Continued review of the QAPI meeting minutes revealed for the prior 5 months, in relation to the survey conducted in September 2024, an average of 44.3% of the facility’s patients did not meet established fluid volume management parameters. The fluid volume status (Estimated Dry Weight-EDW) is established by the Nephrologist using kilograms (kg). The unit of measure of 1 kg. (1 kg. = 34 fluid ounces = 2.2 pounds) as the preferred unit of measure. The EDW is referred to as a baseline weight to establish safe fluid removal (not having symptoms) as a result of removal of too much fluid removed during the dialysis treatment process. Dialysis patients are advised by their Nephrologist and their care team to limit fluid intake to 1 kg. per day between dialysis treatments. Further monthly review showed the following: April 2024- percentage of patients not meeting the monthly fluid volume management parameter was 45.2%, May 2024- percentage increased to 48.8%, June 2024- percentage of patients not meeting the fluid volume management parameter at 40.5%, July 2024- percentage increased to 43.2%, August 2024- percentage of patients not meeting fluid volume management parameters increased to 44%. During an interview on 9/26/2024 at 12:05 PM, the Director of Operations (DO) confirmed the percentage of patients not receiving adequate dialysis treatments had increased, inadequate fluid volume management continued for greater than 40% of the patients, missed treatments and re-hospitalizations identified by QAPI data remained quality indicator issues. During an interview on 9/27/2022 at 10:45 AM, the Medical Director(MD) confirmed he was responsible for the day-to-day operation of the dialysis facility and ultimately responsible for the clinical outcomes of patients at the dialysis clinic. The Medical Director stated he is also an attending Nephrologist at the facility as well. Continued interview revealed the MD voiced his rationale for not consistently implementing the Corporation provided, evidence-based, quality indicator driven algorithms was “...I know my patients...the algorithms don’t take into consideration of how sick they are...” The MD confirmed he had knowledge of 1 patient who had met only 1 of the quality indicators since admission in April of 2024 for dialysis services. Continued interview revealed the MD stated he was aware of various patients not meeting dialysis adequacy and other quality indicators/measures for 2024 so far, he stated the quality indicators are reviewed monthly in QAPI meetings, but when asked he could not voice an intervention implemented. When the MD discussed the various quality indicators/measures, he confirmed “...the quality is low...” The MD voiced he believed the “Culture” of the clinic was attributed to the traditional past poor performance of the facility in relation to patients not meeting quality indicator goals.”