Usrc Edgefield

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 28883 Based on observations, interviews, and review of the facility’s policies and procedures, the facility failed to ensure staff responsible for monitoring and changing external wetted transducer protectors adhered to the facility’s policies for management of wetted external transducer protectors for 3 of 4 staff identified as responsible for the management of the external transducers during hemodialysis. Lack of accurate management of the external transducer protectors could potentially cross contaminate the dialysis machine with blood borne pathogens for other patients. The findings are: Cross Reference to V-0120: Dialysis staff responsible for monitoring and changing wetted external transducer protectors failed to change 3 of 4 wetted external transducer protectors per the facility’s policy and failed to inspect the backside of 2 of 4 wetted external transducer protectors when removed from the dialysis machine.”

“IC-TRANSDUCER PROTECTORS-NOT WETTED/CHANGED CFR(s): 494.30(a)(1)(i) Use external venous and arterial pressure transducer filters/protectors for each patient treatment to prevent blood contamination of the dialysis machines’ pressure monitors. If the external transducer protector becomes wet, replace immediately and inspect the protector. If fluid is visible on the side of the transducer protector that faces the machine, have qualified personnel open the machine after the treatment is completed and check for contamination. This includes inspection for possible blood contamination of the internal pressure tubing set and pressure sensing port. If contamination has occurred, the machine must be taken out of service and disinfected using either 1:100 dilution of bleach (300-600 mg/L free chlorine) or a commercially available, EPA-registered tuberculocidal germicide before reuse. Change filters/protectors between each patient treatment, and do not reuse them. Internal transducer filters do not need to be changed routinely between patients. This Standard is not met as evidenced by: 28883 Based on observations, interviews, and review of the facility policy, titled,”Intradialytic Monitoring of Patient”, the dialysis clinic nursing staff failed to immediately change a blood wetted external transducer protector for 3 of 4 patients (Patient #2, #6, and #7). Registered Nurse (RN) #1 and Patient Care Technician (PCT) #2 failed to inspect the backside of the external transducer protector for Patient #2 and #7 to determine if blood could have leaked to the backside of the wetted external transducer protector causing potential cross contamination of the hemodialysis machine with a potential bloodborne pathogen. PCT #2 could not state the action to take if blood/fluid was observed on the backside of the external transducer protector. The findings included: Observations on 3/4/24 at 12:55 PM, 1:06 PM, 1:17 PM, 1:40 PM, 2:07 PM, 2:15 PM, 2:40 PM, and 3:15 PM revealed Patient #7 dialyzing at dialysis machine 6 in dialysis station 15. The venous external transducer protector was wet on the front side with blood at the above times. Observation on 3/4/24 at 3:33 PM revealed RN #1 disconnected the wet external transducer protector from the dialysis machine with the lines and dialyzer. RN #1 did not inspect the backside of the wet external transducer protector. RN #1 took the lines and dialyzer to the biohazard box for disposal. RN #1 was informed of the observations related to RN #1 not inspecting the backside of the wetted external transducer protector. Upon inspection of the wetted external transducer protector, no blood or fluid breakthrough was observed on the backside of the wet external transducer protector. RN #1 verified she/he had not inspected the backside of the wet external transducer protector. On 3/5/24 at 2:51 PM, review of the patient’s dialysis treatment sheet dated 3/4/24 revealed documented patient and/or dialysis machine checks at 1:05 PM, 1:36 PM, 2:10 PM, and 2:39 PM without changing the wetted external transducer protector. Observations on 3/4/29 at 1:49 PM, 2:07 PM, 2:15 PM, and 2:28 PM revealed Patient #2 dialyzing at dialysis machine 2 in dialysis station 11. The venous external transducer protector was wetted on the front side with blood at all of the above times. Observations on 3/4/24 at 2:53 PM revealed PCT #2 at dialysis machine 2 in dialysis station 11. PCT #2 disconnected the external transducer protector that was wetted with blood on the front side from the dialysis machine, removed the lines/dialyzer, and without inspecting the back side of the wet external transducer protector, was attempting to place the lines/dialyzer into the biohazard container. When PCT #2 was informed that the front side of the venous external transducer protector was wetted with blood, PCT #2 observed the wet external transducer protector and verified that she/he had not observed the wet external transducer protector’s back side prior to attempting to discard it. When asked what action was necessary when blood was observed on the front side of the external transducer protector, PCT #2 stated the wet external transducer protector would require changing but could not verbalize what to do for blood strike through on the back side of the wetted external protector. When asked to look on the backside of the wetted external transducer protector, PCT #2 and the surveyor observed the backside of the wetted external transducer protector which did not have blood or fluid. After a moment, PCT #2 stated that she/he would need to check for breakthrough on the backside. When asked what was required if there was blood on the backside of the wet external transducer protector, PCT #2 did not state to pull the dialysis machine for inspection for potential internal contamination from blood borne pathogens. PCT #2 stated she/he had not been told about doing that. The wet external transducer protector was observed wetted with blood from 1:49 PM until the patient’s dialysis treatment ended at 2:30 PM. Review on 3/5/24 at 10:40 AM of the patient’s dialysis treatment sheet dated 3/4/24 revealed PCT #2 had documented a dialysis machine line check at 2:08 PM, but the wet external transducer protector was not changed. Observations on 3/4/24 at 1:40 PM, 1:46 PM, 2:07 PM, 2:15 PM, and 2:40 PM revealed Patient #6 dialyzing on dialysis machine 5 in dialysis station 13. The venous external transducer protector was observed wetted with blood on the front side at all of the above times. Review on 3/5/24 at 10:40 AM of the patient’s dialysis treatment sheet dated 3/4/24 revealed nursing staff documented either patient or dialysis machine checks at 2:09 PM and 2:39 PM. The nursing staff did not change the wet external transducer protector until 3:32 PM. On 3/6/24 at 11:01 AM of the facility policy provided by the dialysis clinic, entitled, “Intradialytic Monitoring of Patient”, revealed, “....direct patient care staff will monitor the dialysis delivery system during each dialysis treatment that included the integrity of the extracorporeal circuit. They are to monitor pressure readings (check arterial and venous drip chambers are filled with blood but are not backed up into the transducer filter protector). If the transducer filter becomes wet, replace immediately. Inspect the side of the protector that faces the machine. If fluid is visible, biomed technician will be notified and machine taken out of service after dialysis treatment is completed.””

“CARBON ADSORP-ACTION IF FIRST TEST + CFR(s): 494.40(a) 5.2.5 Carbon adsorption: action if first test positive When samples from the first sampling port are positive for chlorine or chloramine, operation may be continued for a short time (up to 72 hours) until a replacement bed is installed, provided that samples from the second sampling port remain negative. The replacement bed should be placed in the second position, and the existing second bed should be moved to the first position to replace the exhausted bed. If it is not possible to rotate the position of the beds, both beds should be replaced. This Standard is not met as evidenced by: 28883 Based on observations, interview, and review of the facility policy, titled, “Total Chlorine Testing”, Patient Care Technician #1 who was one of one PCT observed performing the total chlorine check on the quality water failed to accurately identify the port to check if testing after the primary Carbon tank indicated a total Chlorine level of greater than or equal to 0.1 parts per million (ppm). The findings included: Observations on 3/4/24 at 2:16 PM revealed Patient Care Technician (PCT) #1 performing a total Chlorine check on the quality water. After performing the check at TP4, the port after the primary Carbon tank, PCT #1 was asked what she/he would do if the total Chlorine check resulted in a total Chlorine level greater that 0.1 ppm (parts per million). PCT #1 stated she/he would do a re-check of the sample at TP4. If the total Chlorine was still greater than 0.1 ppm, she/he would do a check at the port after the second Carbon tank, and pointed to the port labeled TP3 which was incorrect as the port labeled TP3 was actually located before the primary carbon tank. Review on 3/6/24 at 11:21 AM of the facility policy provided by the dialysis clinic, entitled, “Total Chlorine Testing” revealed that if the results of repeat Total Chlorine testing from the primary Carbon filter indicate a level of greater than or equal to 0.1 ppm, a sample should be drawn from the sample port located downstream of the second (secondary) Carbon tank or set of tanks.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 28883 Based on a review of the dialysis treatment sheets, the Fresenius 2008K2 Operator’s Manual, the clinic policy, entitled, “Initiation of Dialysis Treatment”, and interview, the nursing staff failed to identify and act on a dialysis machine conductivity parameter that was out of range for Patient #1 for 1 of 6 patients. The findings included: On 3/5/24 at 12:29 PM, review of a dialysis treatment sheet for Patient #1 dated 1/26/24 revealed the meter conductivity had been documented as 13.9 mS (milliSeconds) and the theoretical conductivity had been documented as 13.4 mS which was greater than 0.4 mS/cm(centimeters) difference. There was no indication of any action taken to resolve the discrepancy before the patient’s dialysis treatment started. The finding was verified by the Regional Director during an interview on 3/6/24 at 1:28 PM. On 3/6/24 at 10:28 AM, review of the Fresenius 2008K2 Operator’s Manual revealed staff are to verify conductivity is within 0.4 mS/cm (centimeters) of the theoretical conductivity, and the pH between 6.9 and 7.6. If conductivity and pH are not within these limits, do not initiate dialysis. On 3/6/24 at 11:01 AM, review of the policy provided by the dialysis clinic, entitled, “Initiation of Dialysis Treatment”, revealed two staff members must verify and document on the flow sheet indicating the conductivity and pH are within acceptable parameters. They are to verify that both the actual conductivity value on the machine and the phoenix meter value are +/-0.4 mS of TCD (Theoretical Conductivity) value.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 28883 Based on observations and interviews, nursing staff failed to ensure the medication refrigerator was clean and free of a black substance and debris, and expired glucose control solution was not removed from staff access in a storage drawer in the dialysis treatment room. The findings included: Observations on 3/5/24 at 9:40 AM of the medication refrigerator in the dialysis treatment room revealed a black substance covering the back area/bottom of the refrigerator in spots along with debris (paper/tape). The refrigerator contained parenteral medications that included cath flo activase, the influenza vaccine, Epogen, and Tubersol ppd (Purified Protein Derivative). The finding was verified by Registered Nurse (RN) #1 during an interview on 3/5/24 at 9:42 AM. RN #1 stated that the black spots/debris was from the Mircera (medication) packaging when it got wet. Observations on 3/6/24 at 1:45 PM of the medication refrigerator revealed it still held parenteral medications and had the black substance in the back area/bottom of the refrigerator in spots along with debris (paper/tape). Observations on 3/5/24 at 9:43 AM of a supply storage drawer in the dialysis treatment room revealed 2 opened containers of glucose control solution that expired on 1/13/24. The solution was stored next to the glucometer. The finding was verified by RN #1 on 3/5/24 at 9:45 AM.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 28883 Based on record reviews, review of the facility policy, titled, “Incident and Sentinel Event Reporting”, and interview, the clinic nursing staff failed to ensure adverse occurrences such as clotted dialyzers were documented to ensure monitoring/tracking/trending could be carried out as appropriate. The findings included: On 3/5/24 at 3:06 PM, review of the dialysis treatment sheets for Patient #3 revealed a dialysis treatment sheet dated 2/14/24 that documented the patient’s dialyzer had clotted. A post dialysis comment by the nurse showed the dialyzer clotted with 24 minutes left for the patient’s dialysis treatment and the patient refused a new set up. On 3/5/24 at 3:30 PM, review of dialysis treatment sheets for Patient #4 revealed a dialysis treatment sheet dated 1/26/24 that documented the patient’s dialyzer had clotted. According to the documentation, the TMP alarmed. Due to the patient being Heparin free, the blood flow was decreased with the dialysis treatment ended about 10 minutes later due to dialyzer clotted. On 3/5/25 at 9:14 AM, review of adverse occurrences (e.g., clinical variances, medical errors, unusual events) for the past 6 months revealed one incident listed related to a change in level of consciousness. There was no documentation related to dialyzers clotted. On 3/6/24 at 2:28 PM, review of clinic’s Quality Assurance Process Improvement meeting minutes dated 1/29/24 and 2/23/24 revealed no documentation relative to incidents of clotted dialyzers to indicate monitoring or tracking/trending of these type of incidents. During an interview on 3/6/24 at 3:05 PM, the Regional Director verified there was no documentation in the facility incident reporting system of the clotted dialyzers for the two patients in January 2024 and February 2024 or documentation of review of the incidents during the clinic’s QAPI (Quality Assessment Performance Improvement) meetings. On 3/6/24 at 11:23 AM, review of the facility policy provided by the dialysis clinic, entitled, “Incident and Sentinel Event Reporting” revealed that all occurrences/incidents involving patients would be documented on an occurrence/incident report and reviewed by the Facility Administrator. The incident report must be completed within 24 hours of the occurrence. Common incidents/adverse occurrences include “Clotted Lines/Dialyzer”.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 28883 Based on observations, record reviews, interview, and review of the facility policy, titled, “Initiation of Dialysis Treatment”, the nursing staff failed to ensure the dialysis treatment sheet documentation included comments about the patient’s status at least every 30 minutes for (Patient #1, #3, #4, and #5) which was 4 of 5 patients reviewed for monitoring. One of four random patients observed for dialysis treatment initiation did not have orders followed related to the dialysate flow rate. The findings included: On 3/5/24 at 12:29 PM, review of the dialysis treatment sheets for Patient #1 revealed staff had not documented monitoring of the patient at least every 30 minutes. A dialysis treatment dated 1/29/24 documented the dialysis treatment started at 1:50 PM with a comment indicating monitoring at 3:05 PM, but missing the 2:30 PM monitoring. A dialysis treatment dated 2/19/24 documented monitoring at 2:33 PM and again at 3:33 PM. A dialysis treatment dated 2/28/24 documented monitoring at 2:32 PM and again at 4:07 PM. A dialysis treatment dated 3/4/24 documented monitoring at 2:43 PM and again at 3:34 PM, at 3:35 PM, and again at 4:40 PM. On 3/5/24 at 3:06 PM, review of the dialysis treatment sheets for Patient #3 revealed monitoring had not been documented at least every 30 minutes. A dialysis treatment sheet dated 3/4/24 documented monitoring at 9:08 AM and again at 10:09 AM. On 2/23/24, staff documented a blood pressure and pulse at 8:06 AM and again at 9:00 AM and a comment related to monitoring at 8:06 AM and again at 9:08 AM. On 3/5/24 at 3:20 PM, review of the dialysis treatment sheets for Patient #4 revealed monitoring had not been documented at least every 30 minutes. On 2/9/24, a comment for monitoring had been documented at 4:01 PM and again at 5:01 PM, and on 1/22/24, monitoring had been documented at 4:33 PM and again at 5:33 PM. On 3/6/24 at 9:47 AM, review of the dialysis treatment sheets for Patient #5 revealed monitoring had not been documented at least every 30 minutes. On 2/23/24, staff documented comments at 8:02 AM and again at 9:02 AM. On 2/14/24, monitoring had been documented at 7:02 AM and again at 8:05 AM. On 3/6/24 at 11:01 AM, review of the facility policy provided by the dialysis clinic, entitled, “Initiation of Dialysis Treatment”, revealed direct patient care staff will monitor certain parameter during treatment and make a comment regarding the patient status/observation at least every 30 minutes. The findings related to lack of monitoring every 30 minutes was verified by the Regional Director during an interview on 3/6/24 at 1:32 PM. Observations on 3/4/24 at 3:01 PM revealed Registered Nurse (RN) #1 initiating a dialysis treatment for a patient on dialysis machine 4 in dialysis station 4. The dialysis treatment was started at 3:12 PM with the dialysate flow rate at 500. Observations on 3/4/24 at 3:46 PM with RN #2 revealed the dialysate flow rate was at 500. Review of physician orders with RN #2 revealed the ordered dialysate flow rate was 600. On 3/6/24 at 11:01 AM, review of the facility policy provided by the dialysis clinic, entitled, “Initiation of Dialysis Treatment”, revealed that prior to walking away from the dialysis machine, staff are to verify all prescribed orders including correct dialysate flow rate are followed.”