Initial Comments:
Based on the findings of an unannounced, onsite Medicare recertification survey conducted on March 4 through March 7, 2024, Fresenius Kidney Care Back Mountain 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 conducted March 4 through March 7, 2024, Fresenius Kidney Care Back Mountain was identified to have the following standard level deficiencies which were determined to be in substantial compliance with the requirements of 42 CFR, Part 494, Subparts A, B, C, and D: Conditions for Coverage for End-Stage Renal Disease Facilities.
Plan of Correction:
494.90(b)(2) STANDARD
POC-INITIAL IMPLEMENTED-30 DAYS/13 TX
Name - Component - 00
Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.
Observations:
Based on review of facility policies/procedures and clinical records, and based on interview with the clinical manager (Employee #1), the facility failed to ensure the initial plan of care (POC) was developed as per facility policy and procedure for one (1) of two (2) patients for whom chronic hemodialysis treatments began after December 1, 2023. (Patient #3)
Findings include:
On March 7, 2024 at approximately 4:06 PM, review of facility policy 45283, titled "Comprehensive Interdisciplinary Assessment and Plan of Care" revealed the following: on page 2:
An initial...plan of care (POC) must be conducted on all patients new to dialysis within...13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.
Patient #3: On March 7, 2024 at approximately 10:24 AM, review of the medical record revealed the chronic hemodialysis start of care date was 01/24/2024. Review of hemodialysis treatment documentation revealed the thirteenth hemodialysis treatment (session) was completed on 02/28/2024.
There was no documentation in the clinical record which provided evidence the initial POC was completed by 02/28/2024.
During interview conducted on March 7, 2024 at approximately 12:04 PM, the CM reported the initial POC is scheduled to be conducted on 03/20/2024 so that family members can attend. There was no documentation in the medical record which provided evidence that the patient and/or family requested a delay in the initial POC meeting.
During interview conducted on March 7, 2024 at approximately 4:20 PM, the CM confirmed that the delay in the development of the initial POC was related to availability issues for the patient's nephrologist.
During interview conducted on March 7, 2024 at approximately 4:20 PM, the CM confirmed the initial POC for patient #3 was not developed by the thirteenth hemodialysis treatment.
Plan of Correction:V 557
The Clinic Manager (CM) or designee will re-educate the Interdisciplinary Team (IDT) staff on:
- Comprehensive Interdisciplinary Assessment and Plan of Care
Emphasis will be placed on ensuring that all Care Plans are completed, signed and dated per policy by all the IDT members, including the patient. The meeting will reinforce that all patients new to dialysis must have their initial care plan completed within thirty (30) days or thirteen (13) out-patient treatments of admission.
The in-servicing will be completed by March 27, 2024, with documentation of the training on file at the facility.
The CM or designee will perform monthly audits of all newly admitted patient's Care Plans for the next three (3) months. At that time, if one hundred percent (100%) compliance is observed, the audits will then be completed following the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (POC) specific audit tool will be used for the audits.
Issues of non-compliance will be addressed by the CM with re-education and counseling.
The CM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: April 30, 2024
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 review of facility policies/procedures, clinical records and documentation, observation, staff interview (Employee #3) and interview with the clinical manager (Employee #1), the facility failed to ensure planned actions were completed for two (2) of two (2) action plans (performance improvement projects). (Action Plans #1 and #2)
Findings include:
On March 7, 2024 at approximately 11:42 AM, review of facility policy 26799, titled "Quality Assessment and Performance Improvement Program" revealed the following on page 5:
Following root cause analysis, action plans will be determined...The facility must take immediate and appropriate actions to address any serious threats and ensure patient safety.
During observation of hemodialysis staff between March 4, 2024 at approximately 9:45 AM and March 6, 2024 at approximately 11:01 AM revealed the following:
Employee #2: After inserting the access needles into the fistula and completing the treatment initiation process for the patient seated at station #12 during the second shift on 03/05/2024, the registered nurse (RN) carried the laboratory specimen to the lab room. After departure from the laboratory specimen room, the RN removed gloves but failed to perform hand disinfection/washing before obtaining a clean pair of gloves from the supply box.
After removing the access needles from the fistula from the patient seated at station #4 during the second shift on 03/05/2024, the RN removed gloves but failed to perform hand disinfection/washing before obtaining additional clean supplies to complete the hemodialysis treatment termination process.
After removing one (1) blood line from the central venous catheter (CVC) for the patient seated at station #6 during the first shift on 03/06/2024, the RN removed gloves but failed to perform hand disinfection/washing before obtaining a new pair of gloves from the supply box. The RN then removed the second blood line but failed to perform hand disinfection/washing after completion of the treatment termination process.
Employee #3: After inserting the access needles into the fistula for the patient seated at station #1 during the second shift on 03/05/2024, the RN entered the medication preparation room without removing personal protective equipment (gown and gloves), The RN then proceeded to remove gloves but failed to perform hand disinfection/washing before preparing an intravenous (IV) medication. During interview conducted on 03/05/2024, the RN reported that the IV medication which the RN prepared was heparin.
Employee #4: After removing the bloodlines from the access needles for the patient seated at station #5 on the first shift on 03/06/2024, the certified clinical hemodialysis technician (CCHT) removed gloves but failed to perform hand disinfection/washing before obtaining a clean pair of gloves from the supply box.
Patient #1: On March 6, 2024 at approximately 1:22 PM review of the medical record revealed the blood/bloodline culture obtained on 12/30/2023 was positive for growth of viridans streptococcal group (bacteria).
Patient #3: On March 7, 2024 at approximately 10:24 AM review of the medical record revealed the blood/CVC culture obtained on 02/09/2024 was positive for growth of staphylococcus huminis (bacteria).
Patient #4: On March 7, 2024 at approximately 12:19 PM, review of laboratory results included in the medical record revealed the patient is hepatitis C reactive (positive).
Patient #5: On March 7, 2024 at approximately 1:37 PM, review of the medical record revealed Vancomycin (antibiotic) was administered on 01/26/2024 after assessment findings documented by the RN (Employee #1) revealed the CVC site exhibited greater than expected redness and tenderness at insertion site.
Action Plan #1: On March 6, 2026 at approximately 11:56 AM, review of an "Action Plan" implemented on 01/12/2024 revealed the following:
Analysis of Findings (Root Causes)/Goals: Goal for 100% adherence to infection control policies and procedures by the end of the increased auditing period.
Actions Planned/Time Frame/Person Responsible:
-Infection control audits increased to twice weekly;
-Staff Acknowledgment to be signed regarding infection control policies and where to find applicable polices;
-Time Frame: Increased auditing period over 6 weeks;
-Person responsible: Clinical manager (CM).
Review of infection control audit findings documentation revealed week six (6) of the twice weekly infection control audits was completed on 03/01/2024.
There was no documentation the CM (Employee #1) completed the planned action for hemodialysis staff to sign an acknowledgment regarding infection control policies and where to find applicable polices.
Patient #4: On March 7, 2024 at approximately 12:19 PM, review of the medical record revealed the following was documented on the hemodialysis treatment sheet dated 02/26/2024:
-8:03 AM: 200 milliliters (ml) of normal saline solution (NSS) was administered for blood pressure of 85/38 which was obtained at 8:01 AM, The next blood pressure assessment (91/47) was documented as having been completed at 8:29 AM which was 26 minutes after the administration of NSS.
-9:31 AM: 100 ml of NSS was administered for a blood pressure of 82/40, The next blood pressure assessment (89/44) was documented as having been completed at 10:00 AM which was 29 minutes after the administration of NSS.
Action Plan #2: On March 6, 2026 at approximately 11:58 AM, review of an "Action Plan" implemented on 01/14/2024 revealed the following:
Analysis of Findings (Root Causes)/Goals: Goal to achieve medical record documentation which is free from omission or errors.
Actions Planned/Time Frame/Person Responsible:
-CM to pull 4 treatment records from the treatment week to review errors with staff the following week.
-Time Frame: Increased treatment sheet auditing period over 6 weeks starting 01/22/2024.
-Person responsible: Clinical manager will audit treatment sheet records, provide feedback to staff and documents updates in the action plan.
Review of treatment sheet audit documentation revealed during week 1 (01/22/2024 through 01/25/2024), one (1) instance of low blood pressure with fluid administration did not include a recheck of the patient until 14 minutes later when "ideally", the need to recheck the patient is within 5 to 7 minutes.
There was no documentation the CM (Employee #1) completed the planned action to review treatment sheet omissions/errors with staff the following week and to provide feedback to staff as required in the above referenced action plan.
During interview conducted on March 7, 2024 at approximately 4:20 PM, the CM confirmed the above referenced planned actions were not completed as per the requirements included in action plans #1 and #2.
Plan of Correction:V 638
To ensure compliance the Director of Operations (DO) or designee will in-service the Interdisciplinary Team (IDT) members on policy:
- Quality Assessment and Performance Improvement Program
The meeting will focus on ensuring that QAPI meetings review the importance of showing review, discussion, trending, and action plans of quality outcomes. The meeting will re-educate that QAPI committee must address any problem area. This includes development and implementation of a root cause analysis and action plans for identified issues. Areas of concern include infection control such as following policies for hand hygiene and use of personal protective equipment. Documentation of the patient's treatment is another identified area addressing and documenting blood pressures that are out of range and follow up with interventions. The meeting will re-educate the IDT members on the need to ensure that action plans are implemented as stated. The meeting will stress that the plans must be reviewed monthly with discussion of the progress of the plan.
The in-service will be completed by March 27, 2024. Documentation of the in-servicing is on file at the facility.
To maintain compliance, the CM will review the audit results monthly for three (3) months prior to the QAPI meeting. The DO will monitor the monthly QAPI minutes to ensure that the monthly audits, including infection control, are being reviewed and tracked via the QAPI meetings. The DO will ensure the development, implementation and monthly review of action plans as indicated. The DO review of the QAPI minutes will be performed monthly over the next 3 months. If compliance is maintained the audits will then follow the QAPI audit schedule.
Issues of non-compliance will include re-education and counseling by the DO.
Sustained compliance will be monitored by the QAPI committee.
Completion Date: April 30, 2024
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