Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 6/6/25, FMC Dialysis Services Of Berwick 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 Medicare recertification survey completed 6/6/25, FMC Dialysis Services of Berwick was identified 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 for End-Stage Renal Disease Facilities.
Plan of Correction:
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
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;
Observations:
Based on a review of Facility Policy, Clinical Record reviews (CR) and staff interview it was determined the medical director failed to ensure the policy for Nursing Supervision and Delegation was followed for five (5) of five (5) CR's reviewed (CR#1 through CR#5)
Findings include:
A review was conducted of facility policy 6/4/25 at 2:30 PM, Nursing Supervision and Delegation states, "The licensed RN cannot delegate any task, skill or practice that requires nursing judgement, critical decision making, or the use of the nursing process, which is 1) assessment, 2) diagnosis, 3) identification of outcomes, 4) planning 5) implementation and 6) evaluation...assessment of each patient preferably within an hour (or according to state requirments) of treatment initiation in the clinic setting....The registered nurse must evaluate each patient preferably within an hour or according to state requirements..."
Review of clinical records on 6/4/25 approximately 10:00 AM revealed the following:
CR#1: Admit date 12/18/24: On 6/2/25 treatment was initiated at 10:21 AM, there was no documentation of a registered nurse evaluation until 12:17 PM.
CR#2: Admit date 6/24/24: On 6/2/25 treatment was initiated at 12:12 PM, there was no documentation of a registered nurse evaluation. On 5/29/25 treatment was initiated at 10:02 AM, there wasa no documentation of a registered nurse evaluation until 12:48 PM. On 5/24/25 treatment was initiated at 10:06 AM, there was no documentation of a registered nurse evaluation until 4:13 PM.
CR#3: Admit date 11/5/24: On 5/31/25 treatment was initiated at 6:15 AM, there was no documentation of a registered nurse evaluation until 1:16 PM.
CR#4: Admit date 12/14/21: On 5/28/25 treatment was initiated at 7:04 AM, there was no documentation of a registered nurse evaluation until 8:17 AM. On 5/26/25 treatment was initiated at 6:19 AM, there was no documentation of a registered nurse evaluation until 2:17 PM.
CR#5: Admit date 4/28/21: On 6/2/25 treatment was initiated at 10:26 AM, there was no documentation of a registered nurse evaluation until 12:15 PM. On 5/28/25 treatment was initiated at 10:07 AM, there was no documentation of a registered nurse evaluation. On 5/21/25 treatment was initiated at 10:27 AM, there was no documentation of a registered nurse evaluation until 12:17 PM.
An interview with the clinical manager at the time of each record review confirmed the above findings.
Plan of Correction:V 715
By June 18, 2025, the Director of Operations (DO) and the clinic manager (CM) will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policy:
- Nursing Supervision and Delegation
The meeting will focus on the importance of the staff always following Fresenius Medical Care (FMC) policies related to the nursing pre-treatment assessment.
Minutes of the meeting with the Medical Director will be on file at the facility for review. The Medical Director will be informed at the meeting that the CM or designee will hold a meeting with the direct patient care (DPC) Registered nursing (RN) staff on the above policy by June 18, 2025. The Medical Director will be informed that the RN education will focus on ensuring that the DPC staff collect the patient data, weight and vital signs prior to the start of treatment. The registered nurse (RN) will evaluate the patient and the collected data preferably within an hour of the start of the treatment. The RN must assess any patient with abnormal vital signs or returning from the hospital.
The RN meeting training documentation will be on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is noted, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if one hundred percent (100%) compliance is sustained, the audits will then follow the monthly Quality Improvement and Performance Improvement (QAPI) schedule. A plan of correction (POC) audit tool will be used for the audits.
The Medical Director will be informed that staff found to be non-compliant will be re-educated and counseled.
To ensure ongoing compliance the CM will review the audit findings with the Medical Director at the QAPI Committee monthly meeting. Sustained compliance and ongoing oversight will be monitored by the QAPI committee.
Completion date: July 25, 2025
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