Initial Comments:
Based on the findings of an onsite unannounced Medicare complaint investigation survey conducted Tuesday September 30, 2025 was identified to have the following standard level deficiency that was 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:
494.90(b)(3) STANDARD
POC-OUTCOME NOT ACHIEVED-ADJUST POC
Name - Component - 00
If the expected outcome is not achieved, the interdisciplinary team must adjust the patient's plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must-
(i) Adjust the plan of care to reflect the patient's current condition;
(ii) Document in the record the reasons why the patient was unable to achieve the goals; and
(iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section.
Observations:
Based on review of policy/procedures, medical records (MR) and interview with facility Administrator the clinic failed to ensure the interdisciplinary team scheduled a meeting with the patient to update the plan of care due to treatment non-adherence for one (1) of three (3) records reviewed. MR #3.
Findings include:
Review of policy: Managing Missed Treatments due to Non-Adherence or Prolonged Hospitalizations or Vacation completed September 30, 2025 at approximately 1:00PM revealed. Purpose: "To provide guidance on managing missed treatments for patients who: miss their scheduled treatments without rescheduling, miss their scheduled treatments and reschedule...". Complex non-adherence; "continues to miss regularly scheduled treatments... routinely misses treatment and is risking health concerns or potential hospitalizations...2. Schedule and interdisciplinary team meeting with the patient to discuss assessment findings and develop a plan to address barriers...".
Review of medical records MR completed September 30, 2025 between approximately 11:30 AM and 12:30 PM revealed the following:
MR #3; Admit date:9/24/24; contained a Plan of Care showing an area of focus goal: "Treatment Adherence" established during the initial meeting dated 10/29/24. The 90 day interdisciplinary team meeting was scheduled for 1/29/25.
Documentation within the record showed the patient shortened or missed treatment on 11/1, 11/8, 11/12, 11/15, 11/22, 11/24, 11/26, & 11/26/24.
During December the patient shortened or missed treatment on 12/2, 12/4, 12/6, 12/9, 12/11, 12/18, 12/20, 12/24, 12/29 & 12/31/24.
In January, the patient shortened or missed treatment on 1/3, 1/10, 1/13, 1/15, 1/17 & 1/20/25.
There was no documentation to show an interdisciplinary team meeting was scheduled after 10/29/2024, per policy, to discuss the missed and shortened treatments, make adjustments to the established goal within the plan of care or to develop a plan to address barriers to care.
An interview with the facility Administrator completed September 30, 2025 at approximately 2:30 pm confirmed the policy as current and the above findings.
Plan of Correction:FRESENIUS KIDNEY CARE PENNSYLVANIA DIALYSIS CENTER READING
Plan of Correction for
Complaint
Provider Identification Number: 39-2549
Date of Survey: 9/30/25
V559 POC-Outcome not achieved-adjust POC
On 11/15/25, the Clinical Manager and/or designee held a staff meeting, elicited input, and reinforced the expectations and
responsibilities of the facility staff on the Policy.
Comprehensive Interdisciplinary Assessment and Plan of Care
Managing Treatment Adherence or Prolonged Hospitalization or Vacation
Emphasis will be placed on:
If the patient specific expected outcome as determined by the attending physician, IDT and patient for the Plan of Care is
not achieved within the identified time frame:
The Interdisciplinary team must adjust the patient's Plan of Care and document changes made to the POC.
Implement the Plan of Care changes to address the identified issues.
Patient adherence to the prescribed treatment plan will be reviewed as part of the IDT clinical assessment and should
determine if the patient's behavior is a health risk or risk of hospitalization. The IDT is responsible for assessing the
level of safety concerns.
Patients who are non-adherent should be referred to the Social Worker who can utilize the Root Cause Analysis and
Intervention Tool for patients not meeting quality goals to assess the reason for the missed treatment and if there's a
barrier that might contribute to more misses in the future.
Effective 11/17/25, the Clinical Manager will conduct 3 days per week audits for 2 weeks utilizing the facility specific audit tool,
with focus on ensuring that if a patient does not meet an expected outcome outlined in the plan of care that the above steps will be
taken per Fresenius Policy. The audits will then go to weekly for an additional 2 weeks or until 100% compliance is achieved.
The Governing Body will determine on-going frequency of the audits based on compliance. Once compliance sustained
monitoring will be done through the Clinic Audit Checklist per QAPI calendar.
The Medical Director will review the results of audits each month at the QAPI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of
Correction prior to presenting to the QAPI Committee monthly.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the
resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The QAPI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The root cause
analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAPI monthly.
The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues
identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAPI and Governing Body minutes, education and monitoring documentation, are available for review at the clinic.
Completion Date: 12/30/25
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