Fkc Shelby

“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: 52064 Based on observation, staff interview, and policy review, the facility failed to ensure sharps containers were not stored in the same area as clean equipment that could be used on patients in their care for one of three survey days. This practice can lead to cross contamination of all 64 patients in the facility. Findings include: During observation in the patient treatment room on 07/07/25 at 12:40 PM it was observed a rolling stand with three sharps containers was pushed into the storage area that also had the emergency evacuation container, oxygen concentrators and two rolling manual sphygmomanometers. Interview with Registered Nurse (RN)7 on 07/07/25 at 12:40 PM confirmed the stand with the sharps containers was in the designated “clean” area and was stored beside patient care equipment. RN7 confirmed that sharps containers were not to be stored beside patient care equipment. Review of the facility’s policy titled, “General Cleanliness and Infection Control Guidelines” published 05/05/25, indicated “The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. All areas must be kept clean and organized.””

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 52064 Based on observation, staff interview, and policy review, the facility failed to ensure equipment used in patient care was disinfected as per facility policy and stored appropriately for one of the three survey days. Failure to disinfect appropriately has the potential to cause harm to all 64 patients dialyzed in the facility. Findings include: During observation in the patient treatment area on 07/07/25 at 12:35 PM, 27 blue hemostats were noted to be laying on a pad in an area designated as “dirty sink.” Four of 27 blue hemostats were in a closed position. In an area designated as “clean sink” a container marked “dirty clamps” was noted. In an interview with Registered Nurse (RN)7 on 07/07/25 at 12:46 PM, he/she acknowledged the blue hemostats had been disinfected and were laying on the pad to dry and some of the clamps were in a closed position. RN7 confirmed the area was marked “dirty” and the clamps should not be stored for drying in a “dirty” area. RN7 also verified the container marked “dirty clamps” was sitting in an area designated as a “clean sink” counter. Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station” published 09/05/23, indicated, “Cleaning Clamps: Place used plastic pressure clamps and plastic hemostat clamps in a labeled opaque plastic container filled with a 1:100 bleach solution...Make sure the items are completely submerged, unclamped, and in open position when placed in the solution.””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 52064 Based on record review, interview, and policy review, the facility failed to follow the individualized dialysis plan (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) by following the physician prescription as determined by the medical provider for four of seven sampled in-center dialysis patients (Patient (P)2, P3, P4 and P6). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for all 64 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P2’s “Treatment Data Sheet” revealed a prescribed Blood Flow Rate (BFR) of 400 milliliters per minute (ml/min), and a Dialysate Flow Rate (DFR) of autoflow 2.0 ml/min or 800 ml/min. Review of two of six flowsheets from 06/25/25 through 07/07/25 indicated the following: a. On 06/27/25 from 9:01 AM until 12:59 PM, the BFR was documented at 400 ml/min and the DFR at 500 ml/min. b. On 07/02/25 from 9:21 AM until 1:21 PM, the BFR was documented at 300 ml/min and the DFR was documented at 600 ml/min. There was no documentation for the change to the prescribed BFR and DFR. 2. Review of P3’s “Treatment Data Sheet” revealed a prescribed BFR of 300 ml/min, and a DFR of 500 ml/min. Review of three of six flowsheets from 06/25/25 through 07/07/25 indicated the following: a. On 06/27/25 from 11:05 AM until 2:55 PM, the BFR was documented at 300 ml/min and the DFR at 600 ml/min. b. On 06/30/25 from 10:49 AM until 2:44 PM, the BFR was documented at 350 ml/min. c. On 07/04/25 from 11:03 AM until 3:28 PM, the BFR was documented at 400 ml/min. There was no documentation for the change to the prescribed BFR and DFR. 3. Review of P4’s “Treatment Data Sheet” revealed a prescribed BFR of 300 ml/min, and a DFR of 300 ml/min. Review of two of six flowsheets from 06/24/25 through 07/05/25 indicated the following: a. On 06/26/25 from 6:39 AM until 10:12 AM, the DFR was documented at 500 ml/min. b. On 06/26/25 from 6:36 AM until 8:34 AM, the DFR was documented at 500 ml/min. There was no documentation for the change to the prescribed DFR. 4. Review of P6’s “Treatment Data Sheet” revealed a prescribed BFR of 350 ml/min, and a DFR of 600 ml/min. Review of two of six flowsheets from 06/24/25 through 07/05/25 indicated the following: a. On 06/26/25 from 11:57 AM until 2:59 PM, the DFR was documented at 500 ml/min. b. On 06/26/25 from 11:49 AM until 2:49 PM, the BFR was documented at 300 ml/min. There was no documentation for the change to the prescribed DFR and BFR. In an interview with the Clinical Manager on 07/09/25 at 10:25 AM, he/she confirmed the above findings, and that staff did not follow the physician’s order for dialysis treatment. Review of facility’s policy titled, “Patient Assessment and Monitoring” published 05/01/23, indicated “...Machine Parameters...Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow...Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.””

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 52064 Based on record review, staff interview, and review of the facility’s document, the facility failed to initiate the algorithm in a timely manner for one of four sampled patient (Patient (P) 3). Failure to initiate the algorithm when ordered resulted in the further decline in hemoglobin (Hgb) values for one of four patients reviewed. Findings include: Review of medical record for Patient (P)3 revealed the following lab values for P3: 06/18/25- Hgb was 10.3g/dl (grams per deciliter) 06/20/25 - Hgb 9.4g/dl; TSAT (Transferrin Saturation) 8 06/23/25 - Hgb 9.1g/dl 06/30/25 -Hgb 8.2g/dl Record review indicated P3’s goal for Plan of Care is Hgb value 10g/dl-11g/dl and TSAT greater than 20. Review of the Provider rounding notes on 06/20/25 indicated, “Impression & Plan. . .3. Anemia-Mircera and Venofer per protocol´ In an interview conducted with the Clinic Manager on 07/09/25 at 10:25 AM, he/she indicated the algorithm for the Mircera was on hold due to low TSAT value and P3 had to receive 10 doses of Venofer 100 milligrams (mg) given during every dialysis treatment before Mircera was initiated. The Clinic Manager stated the Venofer dose had not been started but would be initiated today (07/09/25). The Clinic Manager acknowledged the order to start the Anemia Management Protocol was given on 06/20/25 and it is now 19 days later. Document titled “Anemia Algorithm Dose Change Assessment” last entry date 07/02/25, indicated, “...Prescribed Medication Summary Mircera (blank) Venofer : New Dose New Frequency 100 mg IVP (Intravenous Push) 3 times per week ...On After Date 06/23/25 Number of Doses: 10 Comments: ESA (Erythropoiten Stimulating Agent) Comment: Do not start Mircera until patient has received 1g (gram) iron sequence per iron algorithm... Venofer Comment: Apparent late response to prior calculated dose change or delay in getting order...100mg IVP 3X Week). Medication: Venofer Order Start Date 07/09/25.””