Initial Comments:
Based on the findings of an onsite unannounced Complaint Investigation conducted on October 7, 2025, Renal Care Group - Mt Airy was identified to have the following standard level deficiency 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:
494.150(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 medical records (MR), hemodialysis treatment records, hemodialysis patient schedule, facility policy, and an interview with the clinical manager (CM) and director of operations (DO), the medical director failed to ensure that the facility followed its policy related to Early Termination or Arriving Late to Treatment for one (1) of three (3) MR's reviewed: MR#1
Findings include:
The Facility's Early Termination or Arriving Late for Treatment Policy, Reference Number 45623, reviewed on October 7, 2025 at approximately 11:15 AM reads in part, "Arriving Late: There may be times when a patient's transportation is delayed and arrives late for their scheduled time. If the patient arrives after their scheduled time for dialysis treatment, start the patients' treatment as soon as possible. Staff should do their best to accommodate the patient's prescribed treatment time. If this is not possible due to facility hours of operation, the provider must be notified to review the time delay and determine the appropriate intervention. The facility staff should make every attempt to assist the patient with rescheduling any lost treatment time."
A review of patient schedules and hemodialysis treatment records from 06/30/2025 through 10/04/2025 were reviewed on October 7, 2025 starting at 10:30 AM. The admission date (AD) is indicated below.
MR#1, AD 06/30/2025 was prescribed hemodialysis (HD) treatments for four (4) hours in duration from 6/30/24 to 9/1/25. On 9/3/25, the treatment duration was decreased to 3.5 hours. MR#1 received HD treatments via a central venous catheter (CVC). MR#1 was to have a 1:1 sitter (provided by the family) during HD treatments due to behavioral issues and concern for patient safety
From 6/30/25 to 7/28/25, HD treatment sheets noted that treatments were completed as expected. Treatment times ranged from 3 hours (h) 49 minutes (m) to 4h, 8m.
After 7/28/25 and through 9/1/25, treatment times were periodically less than the ordered duration of 4 hours due to various reasons noted below.
7/30/25: MR#1 was scheduled for HD treatment from 11:45 AM to 3:45 PM. The patient arrived to the dialysis center late. HD treatment was initiated at 1:48 PM and ended at 3:45 PM. Total HD Treatment Time (HDTT): 1h, 57m. The treatment sheet contained a treatment status categorized as 'Complete, Unexpected, Late arrival with inability to extend treatment.'
8/4/25: MR#1 was scheduled for HD treatment from 11:45 AM to 3:45 PM. MR#1 arrived to the dialysis center late, accompanied by family. Treatment was initiated at 12:12 PM and ended at 3:45 PM. Total HDTT: 3h, 33m: The treatment status noted, 'Complete, Unexpected, Late arrival with inability to extend treatment.'
8/11/25: MR#1 was scheduled for HD treatment from 11:45 AM to 3:45 PM. MR#1 arrived to the dialysis center late, accompanied by family. Treatment was initiated at 12:17 PM and ended at 3:47 PM. Total HDTT: 3h, 30m: The treatment status noted, 'Complete, Unexpected, Late arrival with inability to extend treatment, Physician notified.'
8/20/25: MR#1 was scheduled for HD treatment from 11:45 AM to 3:45 PM. Treatment was initiated at 11:50 PM and ended at 2:51 PM. Total HDTT: 3h, 1m. The treatment status noted, 'Complete, Unexpected, Late arrival with inability to extend treatment.' However, MR#1 did not arrive late. A nurses' note stated that treatment ended early for patient safety because MR#1 was restless and confused. repeatedly attempting to get out of the chair, and there was no support person at chairside.
8/25/25: MR#1 was scheduled for HD treatment from 11:45 AM to 3:45 PM. Treatment was initiated at 11:55 PM and ended at 3:08 PM. Total HDTT: 3h, 13m. The treatment status noted, 'Complete, Unexpected, Other.' The HD technician noted that MR#1 was bending the central venous catheter (CVC) causing high venous pressures. The nurses' note stated that MR#1 was pulling on the CVC, unable to be reoriented, restless, attempting to get up, no caregiver at chairside, and therefore, treatment was terminated early.
8/27/25: MR#1 was scheduled for HD treatment from 11:45 AM to 3:45 PM. Treatment was initiated at 12:06 PM and ended at 3:38 PM. Total HDTT: 3h, 32m. The treatment status noted, 'Complete, Unexpected, Transportation.' There was no further documentation as to the issue with transportation, i.e., whether MR#1 arrived late for treatment due to transportation, or left early due to transportation. A nurses' note stated that the MR#1 was agitated throughout treatment, needed continuous redirection related to tugging at the CVC, was able to complete treatment in full (even though the treatment time was 30 minutes short), and that a family meeting was held with the clinical manager (CM) and charge nurse (CN) to discuss MR#1.
8/29/25: MR#1 was scheduled for HD treatment from 11:45 AM to 3:45 PM. Treatment was initiated at 12:15 PM and ended 3:51 PM. Total HDTT: 3h, 36m. The treatment status noted, 'Completed, Unexpected, Transportation.' Although there was no further note elaborating on the issue with transportation, it is assumed that MR#1 arrived late, given that treatment started late and ended at the scheduled time. A note by the CM indicated that the treatment days were going to change to Tuesday, Thursday, and Saturday (TTS), and after consulting with the physician, treatment duration would be decreased to 3.5 hours due to MR#1 achieving optimal and efficient removal of waste products during dialysis.
9/1/25: Treatment orders continued to be 4 hours in duration. Treatment time was 3h, 45m.
9/3/25: This treatment, scheduled for a Wednesday, was listed as absent, in order to initiate the switch to a TTS schedule. Treatment orders were decreased to 3.5 hours. A note entered on 9/3 stated, 'changing treatment days to TTS.'
9/4/25: This was the first treatment on the new TTS schedule as well as the new treatment duration of 3.5 hours. MR#1 was not listed on the 9/4 HD schedule so the scheduled start time was unknown. MR#1's treatment was initiated at 1:30 PM and ended at 3:54 PM. Total HDTT: 2h, 24m. The treatment status noted, 'Complete, Unexpected, Late Arrival with inability to extend treatment.'
9/6/25: MR#1 was scheduled for HD treatment from 12:30 PM to 4:00 PM. Treatment was initiated at 12:53 PM and ended 3:55 PM. Total HDTT: 3h, 2m. The treatment status noted, 'Completed, Unexpected, Late Arrival with inability to extend treatment.'
9/9/25: MR#1 was scheduled for HD treatment from 11:55 AM to 3:25 PM. Treatment was initiated at 12:46 PM and ended 2:32 PM. Total HDTT: 1h, 46m. The treatment status noted, 'Completed, Unexpected, Transportation.' A nurses' note stated, "when MR#1 arrived to clinic, after treatment was initiated, the family member mentioned leaving the clinic to go to the post office. Explained to daughter that if s/he leaves, the facility must terminate treatment. MR#1 was left patient alone for approximately 20 minutes. MR#1's treatment was terminated early."
MR#1 was scheduled to receive 4 hours of HD treatments from 6/30/25 to 9/1/25, then 3.5 hours of treatment after 9/1/25. Between 7/30/25 and 9/9/25, there were eight (8) instances of MR#1 arriving late to the clinic, and three (3) instances involving MR#1's behavior that led to shortened treatments. The facility's "Early Termination or Arriving Late for Treatment" Policy states that staff should do their best to accommodate the patient's prescribed treatment time, and if that is not possible due to facility hours of operation, the provider must be notified to review the time delay and determine the appropriate intervention.
There was no evidence during the time frame of 7/30/25 to 8/28/25 of the physician/provider being notified of MR#1's late arrivals that resulted in short treatment times, except for 1 instance of physician notification by the assigned nurse on 8/11/25. A clinical note by the CM on 8/29/25 indicated that physician discussion took place regarding reduction of the treatment time from 4 hours to 3.5 hours.
All HD treatments after 9/9/25 through 10/4/25 met the expected treatment duration of 3.5 hours.
An interview with the director of operations on October 7, 2025 starting at 2:40 PM confirmed the above findings.
Plan of Correction:V715 MD resp-Ensure all adhere to P&P
By 10/25/25, the Clinic Manager (CM) and/or designee will review citations from the Statement of Deficiencies via a staff meeting and/or huddles, elicit feedback, and reinforce the expectations and responsibilities of the staff on the following Policies and Procedures:
Early Termination or Arriving Late for Treatment
Early Termination of Treatment Against Medical Advice Form
Emphasis will be placed on:
There may be times when a patient's transportation is delayed and arrives late for their scheduled time.
If the patient arrives after their scheduled time for dialysis treatment start the patient's treatment as soon as possible.
Staff should do their best to accommodate the patient's prescribed treatment time. If this is not possible due to facility hours of operation, the provider must be notified to review the time delay and determine the appropriate intervention. ·
The facility staff should make every attempt to assist the patient with rescheduling any lost treatment time.
If late arrivals are not due to an atypical problem with the patient's transportation, but rather a habitual behavior consider the following: ·
Explore reasons for the late arrivals with the patient and determine what solutions can be implemented to help the patient arrive on time for scheduled treatments.
The facility Social Worker should explore available assistance from community-based organizations to support timely attendance.
Counsel and educate the patient on effects of shortened treatment. If needed, schedule an Interdisciplinary team Care Plan meeting with the patient/family/support system.
Patients requesting early termination of a treatment in an outpatient facility will be referred to the supervising registered nurse. The registered nurse (RN) will evaluate the patient and discuss with the patient their reasons for requesting to terminate their treatment earlier than prescribed. If the patient's reasons for terminating the treatment early are due to complications of the treatment such as cramping, discomfort, or anxiety, the RN will discuss these issues with the patient, interdisciplinary team (IDT), and provider and implement any prescribed or recommended interventions to alleviate the patient's symptoms.
The RN who evaluates the patient must document the rationale for early termination and reinforce the consequences of not receiving the entire prescribed treatment.
Picture The RN is responsible for notifying the provider and ensuring that the "AMA", or Against Medical Advice form is completely signed.
The in-service attendance forms document this activity and are available for review at the facility. Any employees not in attendance will be educated on return to the facility.
For ongoing compliance, effective 10/27/25, the CM and/or designee will conduct daily audits for 2 weeks on 10% of pt census to ensure clinical staff utilizing facility specific auditing tool. A POC specific auditing tool will be used for the audits. Once compliance is sustained at 100%, the Governing Body will decrease frequency to weekly for 4 weeks then resume regularly scheduled audits based on the QAPI calendar. Monitoring will be done through the clinic audit checklist.
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.
Completion Date: 11/24/25
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