Fmc Monadnock Dialysis Center

“ADVERSE EVENTS-ACTIONS EXPECTED CFR(s): 494.40(d) A dialysis facility must maintain active surveillance of patient reactions during and following dialysis. When clinically indicated (for example, after adverse patient reactions) the facility must- (1) Obtain blood and dialysate cultures and endotoxin levels; (2) Evaluate the water purification system; and (3) Take corrective action. This Standard is not met as evidenced by: 43408 Based on record review and interview, it was determined that the ESRD (End Stage Renal Dialysis) facility failed to perform and document all the actions expected following an adverse patient reactions for 3 of 3 patient records reviewed. (Patient Identifiers are #1, #2, and #3). Findings include: Review on 1/30/25 of the ESRD facility policy titled “Device Evaluation Following Patient Event”, published 4/5/21, revealed “...1. The Clinical Manager (CM), Program Manager (PM, supervising RN [Registered Nurse] onsite, or RN present during a patient event, as appropriate, will immediately review patient event with the Area Technical Operations Manager (ATOM) and the patient’s Treating Nephrologist, Supervising Physician or Medical Director as required by Patent Adverse Event Reporting and Documentation policy. 2. The Treating Nephrologist, Supervising Physician or Medical Director, in consultation with ATOM, will evaluate the patient event and determine if a device potentially contributed or caused the patient event...if the machine passes the functional test/self-test portion for the “Device Evaluation Following Event” form, and it is believed that the device was not, in any way, involved in causing or contributing to the event then... the machine may be returned to service immediately upon authorization by the Medical Director, Clinical Manager/Program Manager/Regional Technical Operations Manager and/or Area Technical Operations Manager. No further authorization from Corporate Clinical Services is required...” Patient #1 Review on 1/30/25 of Patient #1’s incident report, dated 11/22/24, revealed that Patient #1 had ended treatment early related to developing chest pain and was transported to the hospital. Further review of Patient #1’s incident report revealed no evaluation of the patient event to determine if a device potentially contributed or caused the patient event with the ATOM and physician. There was no evidence a”Device Evaluation Following Event” form was completed. Patient #2 Review on 1/30/25 of Patient #2’s incident report, dated 11/25/24, revealed that Patient #2 had become unresponsive after ending treatment and was sent to the hospital for evaluation. Further review of Resident #2’s incident report revealed no evaluation of the patient event to determine if a device potentially contributed or caused the patient event with the ATOM and physician. There was no evidence that a “Device Evaluation Following Event” form was completed. Patient #3 Review on 1/30/25 of Patient #3’s incident report, dated 1/2/25, revealed that after ending treatment Patient #3 had a change in consciousness, was unable to respond verbally and required 4 responders to transfer from the treatment chair to the stretcher. Further review of Resident #3’s incident report revealed no evaluation of the patient event to determine if a device potentially contributed or caused the patient event with the ATOM and physician. There was no evidence that a “Device Evaluation Following Event” form was completed. Interview on 1/30/25 at approximately 11:00 a.m. with Staff A (Administrator) confirmed the above findings. Interviewed revealed that there was no policy that defined what would be considered an adverse patient reaction. Interview also confirmed that the above patient events were not reviewed with the ATOM and that the cultures and endotoxins were not done and the water purification system was not evaluated and documented on a “Device Evaluation Following Event” form.”