Initial Comments:
Based on an unannounced onsite Medicare recertification survey completed on 12/06/24, ARA Dialysis Unit at Ohio Valley Hospital was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed 12/06/24, ARA Dialysis Unit at Ohio Valley Hospital was found to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30 STANDARD
IC-SANITARY ENVIRONMENT
Name - Component - 00
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.
Observations:
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.
Plan of Correction:The governing body and management staff of this facility takes this deficiency statement very seriously and will ensure that these citations are corrected and that they remain in compliance. The governing body met on 12/16/24 to review and approve the plan of correction and the tools that will keep approved plan in compliance. The in-services and tools are available for review in the facility.
V 111
An in-service was initiated to all Direct Patient Care (DPC) Staff on 12/16/24 by the Clinic Manager (CM) regarding the monitoring of expiration dates on all ancillary supplies including Luer lock caps. Per policy G40 Infection Control "25. No dialysis supplies or medications may be used after the manufacturer expiration date printed on the package, label, or carton." During the in-service it was stressed that supplies such as Luer Lock caps should not be stored in the isolation room. It was additionally stressed that all supplies, including the Luer lock caps in the isolation room, must be checked monthly to ensure expired supplies are not available for staff use. All staff are responsible for checking the expiration date on all supplies, prior to use, to ensure they are not expired. The 6 expired Luer lock caps was discarded, and all supplies were checked to ensure there are no expired supplies available for staff use. Any expired items were discarded and replaced. The Facility Technical Manager (FTM) or designee, as part of the monthly facility inspections, is to ensure that all expiration dates on all stock supplies have been checked to ensure they are not expired. This inspection is documented on the FTM Technical QAPI Monthly Facility Inspections list. The clinic manager (CM) will ensure compliance by observing the expiration dates on all ancillary supplies, including any items such as Luer lock caps in the isolation room, weekly for a minimum of 8 weeks to ensure there are no expired items available for staff use. A CM monitoring tool was developed to monitor this action. The CM will ensure compliance through direct observation and use of the CM monitoring tool. The CM will also review the FTM monthly inspections list, monthly prior to the QAPI meeting. Additionally, the CM monitoring tool and FTM monthly inspections list will be reviewed at the monthly QAPI meeting, of which the medical director is a member, where further action will be taken as deemed appropriate, which could include additional monitoring, more education, and/ or disciplinary action.
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
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;
Observations:
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.
Plan of Correction:V 543
An in-service was initiated to all Direct Patient Care (DPC) staff on 12/16/24 by the Clinic Manager (CM) regarding following the facility charge nurse (CN) notification protocol for reporting patient not meeting blood pressure and heart rate parameters before during, and after treatment. Per IC07A Charge Nurse Notification Protocol it states "Events reportable to the charge nurse by direct patient care staff: Pre Treatment – Blood Pressure: Systolic >180 or <90, Diastolic >100 or <50. Intradialytic – Blood pressure: Systolic >180 or < 90 or any significant change in pressure. Post Treatment: SBP > 180 or <110. Diastolic BP> 90 or <50, Orthostatic BP changes – drops in SBP of > 25 pts or drops in DBP of > 15 pts." Also reportable events per the protocol "Cardiac – Pulse >110 or <55 or an irregular rhythm noted Any c/o chest pain or discomfort." Lastly, per IC07 Patient Assessments: "2. Vital signs will include pre and post dialysis weight, temperature, heart rate and sitting blood pressures on all patients. Standing blood pressure is also done on all ambulatory patients. 5. Pre and post dialysis assessments will include, but not be limited to, assessment of the above data and physical assessment including: Ambulatory status..." The following were stressed during the in-service:
- DPC staff must notify the charge nurse any time the patient's blood pressure or heart rate falls out of the set parameters of the protocol or the patient's individualized parameters set in the physician order, and this must be documented on the patient treatment sheet.
- The charge nurse must immediately perform an assessment on the patient and notify the physician for further orders, if indicated.
- If any intervention was provided, per physician orders (i.e. administration of clonidine), the charge nurse must perform a reassessment of the patient, within a reasonable timeframe, to ensure that the patient's blood pressure improved with the intervention.
- If there is no improvement, the physician must be notified for further orders.
- If trends are noted with patient's not meeting their individualized blood pressure goals, the IDT must be notified, and goals formulated in the Comprehensive Assessment and Plan of Care (CA/POC) process until the patient has achieved their individualized goal.
- Patient's must never be discharged with an elevated blood pressure, without notifying the charge nurse, and an assessment by the charge nurse performed.
- The ambulatory status of each patient must be documented on the treatment flowsheet post treatment.
The Charge Nurse, after each shift of patients is on dialysis, is to round on each patient to ensure their vital signs, including blood pressure and heart rate, are within set parameters of the CN protocol and that the DPC staff are notifying the charge nurse anytime the patient's blood pressure or heart rate is out of parameters. The charge nurse will notify the patient physician and provide intervention to the patient, if ordered, and follow up with the patient to ensure the blood pressure has improved. Additionally, after each shift of patients has completed their treatments, the Charge Nurse is to review the treatment records and verify the BP's and heart rate is being reported to the CN when it is out of parameters and the ambulatory status of each patient is documented. A CN rounding tool was developed to monitoring this action. The CM will also review 100% of treatment flow sheets daily for 2 weeks, until 100% compliance is achieved, and then once a week thereafter for 8 weeks until 100% compliance is achieved, to ensure any patient with vital signs, including blood pressure and heart rate, outside the set parameters of the CN protocol is reported to the CN and the CN notifies the patient physician and there is evidence of this documented in the nursing progress note along with any intervention. Additionally, the ambulatory status is documented on each patient's post treatment. A CM monitoring tool was developed to monitor this action. The clinic manager will ensure compliance by direct review of the treatment records and through review of the charge nurse rounding tool. The findings from the CM monitoring tool and the CN rounding tool, will be reviewed at the monthly Quality Assessment & Performance Improvement (QAPI) meeting, of which the medical director is a member, where additional action will be taken by the committee such as continuing the weekly CM monitoring and/or disciplinary action. - Standing orders for MR3 and MR4 have been reviewed and confirmed to be in place. These standing orders are now explicitly documented in their medical records and are actively being used to guide pre-treatment, intradialytic, and post-treatment care decisions.
- The medical records for MR3 and MR4 were updated to reflect the appropriate standing orders for blood pressure and heart rate parameters. These standing orders are being used to monitor and assess patient care.
- The Clinic Manager will conduct daily reviews of MR3 and MR4's treatment flowsheets to ensure adherence to standing orders. Compliance will be reported during QAPI meetings.
494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE
Name - Component - 00
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.
Observations:
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.
Plan of Correction:V 544
An in-service was initiated to all Direct Patient Care (DPC) staff on 12/16/24 by the Clinical Manager (CM) reinforcing that every part of the dialysis prescription must be supported by a physician order or justified in writing on the treatment sheet as to why the order could not be achieved. This includes the prescribed Blood Flow Rates (BFR) and Dialysate Flow Rate (DFR). Per policy IC08 Monitoring & Documentation of Patient Care During Treatment "4. The following must be documented before "starting" the patient's treatment in the electronic documentation system: Machine checks, Pre-treatment vital signs, Treatment RX – indicating caregiver review and verification of all patient treatment data and machine set-up information, Orders. 10. Data that must be documented ...at least every 30 minutes and PRN depending on patient's condition includes but is not limited to: Blood flow rate (BFR), Dialysate flow rate (DFR). Also, per the policy "15. Information that must be entered manually includes but is not limited to: 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." It was stressed during the in-service that every part of the dialysis prescription must be supported by a physician order or justified in writing the reason the order could not be achieved, and the charge nurse notified. This includes orders for the correct BFR and DFR. It was also stressed that 30-minute checks must be conducted to ensure the treatment is progressing safely and to note any changes (e.g. patients not meeting BFR and/or DFR). If the machine BFR and/or DFR cannot be achieved as ordered, the DPC staff member must document on the treatment sheet the reason that the prescribed orders could not be attained, and the charge nurse notified. The nurse in charge must perform and document an assessment of why the BFR or DFR cannot be achieved, and the physician notified. If any patient continuously is unable to achieve an ordered BFR and/or DFR the IDT must document this on the Comprehensive Assessment and Plan of Care (CA/POC) and document action taken to achieve prescribed BFR and/or DFR with a goal and target dates indicated when the goal will be achieved. The Charge Nurse (CN) will round on all patients shifts to verify that treatment orders are followed per physician order, including the correct BFR and DFR, on all patients and there is documentation on the treatment sheet as to why the BFR and/or DFR cannot be attained. A CN rounding tool was developed to monitor this action. The CM will review 100% of treatment flow sheets daily for 2 weeks, until 100% compliance is achieved, and then once a week thereafter for 8 weeks until 100% compliance is achieved, to ensure all treatment orders are followed per physician order, including the BFR and/or DFR and there is documentation by the DPC staff on the treatment sheet that the CN was notified if orders cannot be obtained and if trends are identified in patient not being able to meet their ordered BFR and/or DFR that the information is included in the Comprehensive Assessment and that plans are formulated with reasonable timelines to ensure the patient meets the ordered BFR. A CM monitoring tool was developed to monitor this action. The clinic manager will ensure compliance by direct review of the treatment records and through review of the charge nurse rounding tool. The findings from the CM monitoring tool and the CN rounding tool, will be reviewed at the monthly Quality Assessment & Performance Improvement (QAPI) meeting, of which the medical director is a member, where additional action will be taken by the committee such as continuing the weekly CM monitoring, further education, and/or disciplinary action.
494.110(b) STANDARD
QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE
Name - Component - 00
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.
Observations:
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.
Plan of Correction:V 638
The Corporate Clinical and Regulatory Manager (CRM) met with the members of the Quality Assessment Performance Improvement (QAPI) team, of which includes the Clinic Manager (CM) and Medical Director (MD), on 12/18/24 to review the requirements of the team measuring, analyzing, and tracking all quality indicators including fluid management. Per policy G09 Quality Assessment & Performance Improvement "Purpose: To ensure that Innovative Renal Care (IRC) care center: monitor appropriate aggregate outcomes and data to optimize patient care and improve processes as applicable. Provide care that promotes patient ability to meet defined individualized patient outcome goals. Regularly review outcome data to identify areas for improvement and take appropriate action to improve outcomes and processes." It was stressed during the in-service that the QAPI process should include tracking, analyzing, and trending fluid management of all patients, including percentage of patients with an Ultrafiltration rate (UFR) greater than 13ml/kg/hr. The QAPI members should review the Fluid Management report in the company's computer reports system (HUB) and bring this to the QAPI meeting for discussion and review. If trends are identified in patients not meeting their fluid management goals a root cause must be determined with action plans formulated, tracked, analyzed, and trended until improvement is noted and documented in the QAPI minutes. The QAPI committee will meet by 1/31/25 to review the fluid management report from January 2024 to present and if any trends are identified an action plan developed based on the root cause. The action plan will be tracked and trended in QAPI until all goals established by the QAPI committee are met. The root cause and action plan information, including the fluid management report, will be documented in the QAPI meeting minutes. The CM will review the fluid management report monthly prior to the QAPI meeting and bring any supporting documentation for review by the QAPI members, of which includes the medical director, and results will be tracked, analyzed, and trended, and a root cause determined, and actions plans developed with reasonable timelines formed to bring the facility back into compliance. To ensure further compliance the QAPI minutes will be reviewed by the Corporate Clinical and Regulatory manager monthly and the minutes will be monitored to ensure facility is trending and analyzing the fluid management on all patients, and that a root cause is determined with an action plan developed that is monitored until the goal is met. Evidence of this review will be documented on the CRM monitoring tool for the next 3 months. Additionally, the Regional Vice President, and/or the Corporate Clinical and Regulatory manager will attend (in person or via phone) the QAPI meetings for the next three months to ensure all areas are being addressed.
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