Fkc Secaucus

“Primary/Alternate Means for Communication CFR(s): §403.748(c)(3), §416.54(c)(3), §418.113(c)(3), §441.184(c)(3), §460.84(c)(3), §482.15(c)(3), §483.73(c)(3), §483.475(c)(3), §484.102(c)(3), §485.68(c)(3), §485.542(c)(3), §485.625(c)(3), §485.727(c)(3), §485.920(c)(3), §486.360(c)(3), §491.12(c)(3), §494.62(c)(3). [(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following: (3) Primary and alternate means for communicating with the following: (i) [Facility] staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. *[For ICF/IIDs at §483.475(c):] (3) Primary and alternate means for communicating with the ICF/IID’s staff, Federal, State, tribal, regional, and local emergency management agencies. This Standard is not met as evidenced by: 30177 Based on review of the “Facility Emergency Management Plan” and interview, it was determined that the facility failed to ensure the “Emergency Management Plan” included an alternate means for communicating with staff in the event of an emergency. Failure to ensure the facility had means for contacting facility staff in the event of an emergency had the potential to hinder the facility’s ability to respond promptly to an emergency and had the potential to negatively affect all 50 in-center hemodialysis patients receiving care at this facility. Findings include: A review of the facility’s undated emergency preparedness plan titled, “Fresenius Kidney Care Emergency Preparedness” revealed the “Emergency Contact Roster” the document contained 15 staff members and failed to include an alternate means for communicating with the 15 staff members. During an interview on 01/11/24 at 10:35 AM, the Facility Administrator confirmed the emergency contact roster did not contain an alternate communication method for 15 of 15 staff members.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 30177 Based on interview, document review, and review of the manufacturer’s prescribed preventative maintenance procedures, it was determined that the facility failed to ensure the 2008T BlueStar Premium hemodialysis machines underwent two-year preventative maintenance. This failed practice did not ensure the hemodialysis machines were maintained in optimum operating conditions. The failure to ensure hemodialysis machines underwent preventative maintenance had the potential to negatively affect the 50 in-center hemodialysis patients receiving care at this facility. Findings include: In a joint interview with the Area Technical Operations Manager (ATOM) and the Biomedical Technician (BMT) on 01/11/24 at 11:10 AM, the ATOM revealed the facility uses 2008T BlueStar Premium hemodialysis machines equipped with extended life components. When questioned about the installation date of the hemodialysis machines, the ATOM responded that all machines were put into service on 05/10/18. The ATOM was asked if the hemodialysis machines required two-year maintenance, which included rebuilding the concentrate (acid), bicarbonate, and ultrafiltration (UF) pumps with extended life components every two years or after 8000 hours of operation. He/she replied, “Yes.” During review of the “Machine/Equipment/Maintenance Technician Worksheet,” six of 22 hemodialysis machines (C [8TOS219122], F [8TOS219303], J [8TOS219389], N [8TOS218698], S [8TOS218419], and V [8TOS221118]) were selected for preventative maintenance review for the six-month, annual, and two-year or after 8000 hours of operation maintenance. Of the six sampled hemodialysis machines, there was no documented evidence that four (C, J, N, and V) of the hemodialysis machines received the required two-year or after 8000 hours of operation preventative maintenance. In a follow-up interview on 01/11/24 at 2:00 PM, the ATOM confirmed that four of six sampled hemodialysis machines (C, J, N, and V) had not undergone the 8000 hours of preventative maintenance required. Review of the manufacturer’s preventative maintenance procedures recommendations revealed, “Preventive maintenance for the 2008T hemodialysis system is simple and straightforward. Schedule maintenance is performed based on time intervals or a number of hours a machine is operated, whichever comes first. The time and hour intervals are as follows ...2008T Bluestar Premium machines concentrate (acid), bicarbonate, and ultrafiltration (UF) pumps with extended life components are rebuilt every two years or after 8000 hours of operation. N.J.A.C. 8:43A-24.11(c)”