Fresenius Kidney Care Spartanburg

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 22313 Based on observations and interviews, the facility failed to ensure that a sanitary environment is maintained in the patient care area. The findings are: On 1/23/24 at 12:05 PM, observations of the patient in dialysis station 9 showed the patient had placed a large bag of personal items on the shelf behind the dialysis treatment chair. At 3:14 PM, the patient finished the dialysis treatment and left with the bag. Patient Care Technician (PCT)#3 cleaned dialysis station 9 preparing for the next patient but neglected to clean the shelf behind the dialysis treatment chair. At 12:15 PM, PCT#3 reported “Oh, I didn’t know that he put anything back there!.” Facility policy, entitled, ‘Infection Control Guidelines’, reads, “Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station”.”

“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 observations, interview, and review of the facility’s policies, “Checking pH of Final Dialysate with Precision pH Control Paper” and “Pre-Treatment Safety Checks Procedure”, two of two Patient Care Technicians (PCTs) observed for initiation of dialysis treatments, (PCT #1 and #2) failed to either perform the independent pH check accurately or perform the independent pH check at all before attempting to start a patient treatment. The findings included: Observations on 1/22/24 at 11:30 AM revealed Patient Care Technician #2 at dialysis machine 6 in dialysis station 12 preparing the hemodialysis machine for patient treatment. At 11:37 AM, PCT #2 placed a pH test strip under the dialysis machine drain line at the wall box and wetted the strip with the fluid. PCT #2 compared the color of the strip to those shown on the pH strip container. During an interview on 1/22/24 at 12:01 PM, PCT #2 stated she/he was performing the independent pH check by getting a sample from the drain line at the wall box. Review on 1/23/24 at 11:18 AM of the facility policy, provided by the dialysis clinic, entitled, “Checking pH of Final Dialysate with Precision pH Control Paper” revealed staff are to “...Obtain sample from the blue Hanson connector of the dialysis machine and place in plastic cup...Dip the test strip into the solution to be tested about 1/2 (inch) for 1-2 seconds...Match color of strip to the color chart...”. Observations on 1/22/24 between 12:22 and 12:41 PM revealed Patient Care Technician (PCT) #1 and Registered Nurse (RN) #1 at dialysis machine 15 in dialysis station 17 preparing the patient and hemodialysis machine for dialysis treatment. At 12:43 PM, PCT #1 disconnected the dialysis lines, rinsed the lines of saline, and handed them to the nurse to attach to the patient’s central venous catheter ports. PCT #1 verified they were getting ready to start the patient’s treatment. When the surveyor asked if PCT #1 had completed all steps necessary before starting the patient’s dialysis treatment, PCT #1 stated that the dialysis machine does its own independent pH check. When PCT #1 was asked to show where the data had been documented, PCT #1 reported the dialysis machine showed that an independent conductivity check had been completed, but not an independent pH check. RN #1 who was present for the interview stated “They usually do the pH check”. Review on 1/24/24 at 4:16 PM of the facility policy, provided by the dialysis clinic, entitled, “Pre-Treatment Safety Checks Procedure” revealed that two direct patient care staff, prior to treatment initiation are to “...Verify conductivity and pH readings: To verify conductivity and pH readings, both staff watch the independent test being performed at the same time or if the test is not performed and results observed by both people, the second person must perform the test a second time to verify the initial test results...”.”

“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: 22313 Based upon observations, record review, and interview(s), the trash cans are overflowing, clinic floor is dirty, and expired supplies are found. The findings are: On 1/22/24 at 11:15 AM, observations in the dialysis treatment room revealed overflowing trash cans in 2 of 3 aisles with soiled gloves and other trash coming out of the top of the trash container. PCT#2’s responded “Not me! It’s always like this.” Facility Policy, entitled, “General Cleanliness and Infection, reads, “All areas must be kept clean and organized, including but not limited to the treatment area. Walkways must be kept clear of debris and free of clutter”. On 1/22/24 at 11:42 AM, during the initial tour, observations showed three suture removal kits expired 9/30/23. Registered Nurse (RD) #2 verified the finding. Facility Policy, entitled, “Storage of Supplies”, reads, “Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date”. Observation on 1/22/24 at 11:50 AM of the Emergency “Crash” cart revealed the crash box was unlocked with 3 vials of Atropine inside along with other medical supplies. The Emergency “Go” box for emergency evacuations is unlocked and open with medications/supplies inside. Registered Nurse (RN) #1 reported “The Pharmacist was here last week and she had trouble getting it closed so just left it open”. Facility policy entitled “Medication Preparation/Administration under ‘Securement’ reads: “All medications will be kept in a locked cabinet except when in use”. On 1/23/24 at 12:40 PM, observations in the dialysis treatment room showed Registered Nurse #2 going from dialysis station to dialysis station checking breath sounds with the individual stethoscope that stays hanging at each station. RN #2 did not sanitize the stethoscope prior to or after use on each patient. Patient Care Technician #5 reported “I guess we really ought to do that”.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 22313 Based upon observation(s) and interview(s), the facility failed to ensure patients’ access ports are uncovered at all times. The findings are: On 1/23/24 at 9:55 AM, observations of the random patient at dialysis station 13 had a blanket pulled up over his head completely covering the access site. The patient was observed intermittently over 3 hours while Registered Nurse (RN)#2 and Patient Care Technician (PCT)#2 returned again and again to check the dialysis machine, but neither staff uncovered the patient’s fistula access at any time. At 1:00 PM, when the patient’s treatment was ending, PCT#2 reported “Oh, he just likes to sleep while he’s dialyzing. I can pull the blanket down, but he will just pull it up again.” Facility policy, entitled, ‘Patient Assessment and Monitoring,’ reads, “Ensure each patient’s face is visible and uncovered. Ensure access remains uncovered throughout the treatment”.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 22313 Based on record review and interview, the facility failed to ensure patient(s) are monitored regularly per policy for 1 of 15 patients. (Patient #2) The findings are: On 1/12/24, Patient #2 underwent a 4 hour dialyzing treatment. Review of the patient’s medical record showed the patient’s blood pressure was checked at the following times: 1/10/24: 12:39, 13:44 by Registered Nurse #3 with a 65 minute gap between monitoring the blood pressure of the patient. 1/12/24: 13:32, 14:28, 15:53 by Patient Care Technician #5 with a 56 minute and an 85 minute gap between monitoring the blood pressures of the patient. Facility Policy, entitled, “Patient Assessment and Monitoring” read, “Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations.” The Facility Manager was interviewed 1/24/24 at 1:00 PM and confirmed the findings.”

“H-PRECONFIG HD SYS-TEST H20/DIALY PER DFU/FDA CFR(s): 494.100(c)(1)(v) Services include, but are not limited to, the following: testing of the water and dialysate system in accordance with- (A) The recommendations specified in the manufacturers’ instructions; and (B) The system’s FDA-approved labeling for preconfigured systems designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramine testing) water and dialysate. This Standard is not met as evidenced by: 28883 Based on record review, interview, and review of the facility policy, “Nxstage PureFlow SL”, the dialysis clinic home therapy nursing staff failed to ensure 8 of 9 home hemodialysis patients had a tap water chemical analysis documented in the past year. The findings included: Review on 1/23/24 and 1/24/24 of the facility’s water chemical analysis reports and home hemodialysis patient dialysate culture and endotoxin reports revealed no tap water AAMIs had been provided. During an interview on 1/24/24 at 9:25 AM, the Home Therapy Program Manager stated they had not gotten all the home hemodialysis patients tap water AAMIs annually, and she/he believed all the home hemodialysis patients were on municipal/city water. Review on 1/24/24 from 9:45 AM through 10:20 AM revealed 8 of the 9 home hemodialysis patients in the clinic did not have documented chemical analyses of their tap water in the past year. Review on 1/24/24 at 2:24 PM of the facility policy provided by the dialysis clinic, entitled, “NxStage PureFlow SL Testing for Water Quality-Chemical”, revealed, that Source water (tap) that does not exceed the NxStage Pureflow SL source water limits would need a chemical analysis for contaminants initially and annually if using municipal or city water sources.”