Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 852595 (X3) Date Survey Completed 02/09/2023
Name of Provider or Supplier Fidelity Home Dialysis Street Address, City, State 1230 Johnson Ferry Pl Suite H30, Marietta, GA
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
E0000 An initial certification survey was conducted at Fidelity Home Dialysis from February 8, 2023 through February 9, 2023. The survey revealed that the facility was in compliance with 42 CFR Part 494.62, Conditions for Coverage for Emergency Preparedness Plan for End Stage Renal Disease facilities. No deficiencies were cited.
V0000 An Initial Certification Survey was conducted at Fidelity Home Dialysis from February 8, 2023 through February 9, 2023. The survey revealed that the facility was in substantial compliance with 42 CFR Part 494 Condition for Coverage for End Stage Renal Disease Facilities. However, standard level deficiencies were cited which resulted from the facility's noncompliance related to the survey. The facility census was two staff-assisted home hemodialysis patients.
V0583 H-TRAIN BY CERTIFIED HOME TRAIN FACILITY
CFR(s): 494.100(a)(1)

The training must- (1) Be provided by a dialysis facility that is approved to provide home dialysis services;


This STANDARD is not met as evidenced by:
Based on a review of records, a review of the State Operations Manual Chapter 2, and staff interview, it was determined that the facility failed to meet one of two general requirements (home training) for Home Hemodialysis Training and Support Services. Approval to provide home training and support services requires the dialysis facility to provide both home training to the patient and/or their care partner in the modality and ongoing support and monitoring of the patient and/or care partner. The facility had two staff-assisted hemodialysis patients at home. Findings include: A review of medical records for two of two patients showed a lack of dialysis training provided to home hemodialysis patients and/or their care partner. A review of the State Operations Manual Chapter 2 - The Certification Process (Revised 190, 06/14/19) stated the following: End Stage Renal Disease (ESRD) Facilities - 2271 General Requirements for Home Training and Support Program: Approval to provide home training and support services requires the dialysis facility to provide both home training to the patient and/or their care partner... An approved home training and support program must include both training and support services. - 2273 Dialysis Modalities and Dialysis Related Services included the following: Home Hemodialysis Training and Support The patient and/or care partner is trained to perform routine hemodialysis treatments at the patient's place of residence by a home training nurse ... Staff-Assisted Dialysis in the Home In order to provide staff-assisted home dialysis, a dialysis facility must be approved to provide Home Training and Support Services. Staff-assisted home dialysis does not require additional approval. During an interview with the Regional Director of Operations on 2/8/23 at approximately 3:00 p.m., it was confirmed that the facility did not train home patients but only admitted patients for staff-assisted hemodialysis at home, provided by a qualified registered nurse.
V0597 H-PROVIDE ORDERED SUPPLIES/EQUIPMENT
CFR(s): 494.100(c)(1)(vi)

Services include, but are not limited to, the following: (vi) Purchasing, leasing, renting, delivering, installing, repairing and maintaining medically necessary home dialysis supplies and equipment (including supportive equipment) prescribed by the attending physician.


This STANDARD is not met as evidenced by:
Based on a review of facility records and staff interview, it was determined that the facility failed to maintain records of preventive maintenance for the home hemodialysis (HHD) machines used for two of two HHD patients. This deficient practice had the potential to negatively affect the health and safety of the two patients who were receiving staff-assisted HHD at home. Findings include: A review of the facility's equipment maintenance logs revealed no documented evidence that routine quarterly and six month preventive maintenance (PM) of the HHD machines used for two of two home patients, were completed in accordance with the manufacturer's recommendations. During an interview with the Facility Administrator on 2/9/23 at 3:35 p.m., she stated that the new Biomed Technician organized the equipment PM records and placed them in one folder, but did not include the quarterly and six month PM records. The Facility Administrator could not provide the missing documents.