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 012515 (X3) Date Survey Completed 04/20/2023
Name of Provider or Supplier Fresenius Medical Care Opelika Street Address, City, State 2609 Village Professional Drive, Suite 2, Opelika, AL
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)
V0101 COMPLIANCE WITH FED/STATE/LOCAL LAWS
CFR(s): 494.20

The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements.


This STANDARD is not met as evidenced by:
Based on review of the Alabama Department of Public Health for Rules for End Stage Renal Disease Treatment and Transplant Centers Chapter 420-5-5, the facility Absence and Hospitalization, Discharged to the Hospital Report documentation, and staff interview, it was determined the facility failed to follow State Licensure Rules for End Stage Renal Disease for reporting all unusual occurrences to the State Survey Agency (SSA) for unscheduled transports to a hospital. This did affect eight of ten unscheduled transfers and had the potential to affect all patients served by the facility. Findings include: Rules of Alabama State Board of Health Alabama Department of Public Health Chapter 420-5-5 End Stage Renal Disease Treatment and Transplant Centers Amended December 18, 2007 page 7 420-5-5-.01 General (7) Unusual Occurrences Unusual occurrences which threaten the welfare, safety and health of patients, personnel or visitors shall be reported by the ESRD (End Stage Renal Disease) facility within 24 hours, either by telephone (and confirmed in writing), or by facsimile to the Alabama Department of Public Health, Division of Health Care Facilities, and other agencies/authorities as required. Examples of unusual occurrences include: misuse of medical devices or medications, defective devices, suspected cases of patient abuse or neglect, life threatening burns, fires or other catastrophic occurrences, medical conditions or deaths that occur as the result of unusual circumstances. Any acute event that results in a patient receiving emergency treatment must be reported. Emergency treatment includes unscheduled transportation to a hospital or receipt of cardiac life support from a hospital, ambulance service or rescue squad, or staff member. Also, to be reported are outbreaks of infectious disease or any condition in the facility, including the water treatment system, which would necessitate the temporary or long term closure of the dialysis facility (excluding inclement weather). Review of the facility Absence and Hospitalization, Discharged to the Hospital Report dated 4/18/22 to 4/18/23, revealed a total of twelve patients were discharged to the hospital. The SSA was notified of only two of the twelve transferred/discharged from the facility by emergency transport to the hospital. An interview was conducted on 4/20/23 at 11:50 AM with EI (Employee Identifier) # 12, Interim Clinical Manager, who verified eight patients documented on the Absence and Hospitalization, Discharged to the Hospital Report were transferred from the facility to the hospital per emergency/ambulance service. EI # 12 confirmed the eight transfers were not reported as unusual occurrences to the SSA over the past 12 months.