Somatus Dialysis of Fall Church, LLC

“Local, State, Tribal Collaboration Process CFR(s): §403.748(a)(4), §416.54(a)(4), §418.113(a)(4), §441.184(a)(4), §460.84(a)(4), §482.15(a)(4), §483.73(a)(4), §483.475(a)(4), §484.102(a)(4), §485.68(a)(4), §485.542(a)(4), §485.625(a)(4), §485.727(a)(5), §485.920(a)(4), §486.360(a)(4), §491.12(a)(4), §494.62(a)(4) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years [annually for LTC facilities]. The plan must do the following:] (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. * * [For ESRD facilities only at §494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility’s needs in the event of an emergency. This Standard is not met as evidenced by: 42725 Based on document review and interview, it was determined the facility failed to make an annual notification to the local emergency preparedness agency to inform the agency of the ESRD facility’s presence and needs in the event of an emergency. Findings: During the review of the facility’s emergency preparedness (EP) plan, the state agency (SA) was unable to locate documentation of the facility’s annual notification to the local EP agency informing the agency of the facility’s presence and needs in the event of an emergency. The SA reviewed specific areas of the EP plan with the leadership team on February 25, 2025 for additional information. The SA inquired about the annual notification letter to the local EP agency. Employee (EMP) 10 advised a previous employee was in the administrator role at that time so (EMP10) would review facility files to see if a letter was sent. On February 26, 2025, EMP10 notified the SA that the facility was unable to locate the annual local EP notification letter.”

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 The dialysis facility must provide or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter. This Standard is not met as evidenced by: 42725 Based on observations and interview, it was determined the facility failed to ensure that expired supplies were discarded and not available for use. Specifically, the supplies used for collecting laboratory blood specimens. Findings: During the tour and observations on February 24, 2025, the SA reviewed the laboratory area and supplies for collecting specimens. An opened package of lithium heparin tubes were in the cabinet with an expiration date of “2/3/25”. The SA inquired about the use of the tubes and EMP2 indicated they are used to collect a specimen after dialysis treatment to test the patient’s treatment adequacy. The SA also identified three sets of bottles used to obtain blood culture specimens that had expired on “1/28/25” and “1/29/25”. The SA inquired about a policy related to supply management and/or specimen collection. EMP10 was unable to locate a policy specifically addressing the two areas. EMP10 provided the SA with a section from the facility’s policy and procedure manual that partly reads: “9. The expiration date will be checked on all disposable supplies before the package is opened and the contents are used. 10. The contents of packages will not be used beyond the expiration date on the package...”. The leadership team acknowledged that expired supplies should be removed and not available for use. The team shared that a review of all laboratory specimens was being conducted to determine if the collection occurred after the tubes expired and if additional action was necessary. Additionally, a review of process and procedures was being conducted to identify any areas of improvement.”