Fkc First State

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 22676 Based on observation, record review, and interview, the facility failed to ensure staff kept medication vials in a secure location. These findings have the potential to negatively impact all 77 in-center dialysis patients receiving care at the facility by allowing filled medication vials to be accessible to patients and visitors which could result in contamination and tampering. Findings include: During an observation on the treatment floor on 02/08/23 from 10:40 AM until 11:30 AM a vial of Heparin (a blood thinning agent) was observed sitting on a cabinet next to the isolation room unattended. An interview with the Nurse Educator (NE) on 02/08/23 at 11:30 AM confirmed the above findings. A review of the facility’s policy titled, “Medication Preparation and Administration” dated 02/06/23, indicated, “All medications will be kept in a locked cabinet except when in use.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 22676 Based on observation, interview, facility policy review, and review of Centers for Disease Control (CDC) guidance, the facility failed to ensure that 23 out of 23 wall boxes (dispensing outlets) at dialysis stations and 15 out of 23 dialysis machines were cleaned and the buildup of white crystals and yellow substance removed. This deficient practice had the potential to cause bacteria to grow in the wall boxes and cause harm by infecting the 77 patients receiving in-center hemodialysis at the facility. Findings included: Observation of the wall boxes on 02/08/24 at 10:45 AM, at each dialysis station, Stations numbered 1-23 revealed dark yellow sediment with white sediment build-up on the dialysis delivery system wall boxes. Observations on 02/08/24 at 10:45 AM revealed that the dialysis machines on the treatment floor numbered #1, #2, #3, #5, #8, #10, #11, #12, #14, #17, #18, #21, #25, #01, and #08 had a dark orange build-up on the front and the bottom with white crystals present. During an interview on 02/08/24 at 11:30 AM, the Nurse Educator (NE) confirmed the condition of the wall boxes and the dialysis machines. A review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, indicated, “ ...Dialysis wall boxes and the area around the wall box must be routinely cleaned at the end of each treatment day .... Special attention should be given to removing build-up and /or cleaning splatter and a spray of concentrate solution ...” A review of the “CDC Dialysis Safety”, located on the CDC website at www.cdc.gov, titled “Wall boxes and Drains” indicated, “All box surfaces should be disinfected at least daily (e.g., at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (e.g., when visibly dirty). Cleaning and disinfection of the wall box should be performed after the patient has left the station, and not during patient care activities ...More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer.””

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 22676 Based on observation, record review, and interview, the facility failed to ensure staff checked the water system for chlorine at least every four hours. These findings have the potential to negatively impact all 77 in-center dialysis patients receiving care at the facility by exposing them to break-through chlorine in the water used for dialysis treatments. Findings include: A review of the chlorine log on 02/08/23 revealed that on 12/04/23 the chlorine was checked at 5:03 AM and then was not checked again until 9:49 AM which was over four hours. An interview with the Chief Technician (CT) on 02/08/23 at 2:30 PM confirmed the above findings. A review of the facility’s policy titled, “Carbon Filtration Monitoring for Incenter Water System Policy’” dated 11/07/22, indicated the water should be checked “at a minimum of every four hours.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 22676 Based on observation, interview, and policy review, the facility failed to ensure that one (1) out of one (1) dialysis unit was clean and in good repair. This deficient practice has the potential to cause bacterial growth in the facility, potentially leading to infections in the 77 in-center dialysis patients at the facility. Findings include: Observation of the treatment on 02/08/24 at 10:45 AM; the floor tiles along the back wall entering the unit across from the laboratory area, about 3 feet by 4 feet area of the wall, was down to the bare sheet rock. The area was not sealed for appropriate cleaning or covered by plastic until such repairs could be made. Observations on 02/08/24 at 10:55 AM revealed that the entire floor along the back wall of the facility had floor tiles that were loose and peeling up. There was a white crystal buildup under the chase wall which contains the dialysis machine connection piping that delivers water, bicarbonate solution and the acid solution used in the dialysis treatment. The floors also had a black buildup of dirt and grime. There was a cart housing containers. The bottom shelf of the cart had a buildup of black grime and had a rusty appearance. Observation in the water treatment area on 02/08/24; the floor was unsealed and was constructed of porous concrete with damage to the concrete noted across the whole water treatment floor. There was black build-up under the water holding tanks. During an interview on 02/08/24 at 11:30 AM, the Nurse Educator (NE) confirmed the conditions of the floor and back wall floor tiles. On 02/09/24 at 11:30 AM, during an interview, the Chief Technician (CT) confirmed the condition of the water treatment floor. CT confirmed the facility did not have a written policy for the physical environment, but they followed the QAIP [Quality Assessment and Improvement Program] tool for reviewing the condition of the facility. A review of the facility’s Technical Quality Assessment and Improvement Program (QAIP) audit tool states: “Are floors clean, intact, and free of damage.””

“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: 22676 Based on a review of glucometer logs, interview, review of glucometer policy, and review of manufacturer’s instructions, the facility failed to ensure that two of two glucometers (treatment floor and Isolation Room) were in the control range and followed the manufacturer’s instructions for use in the facility. This deficient practice has the potential to provide incorrect blood glucose results and could result in inaccurate glucose level results for all 77 in-center dialysis patients receiving care at the facility. Findings include: A review of electronic “Blood Glucose Logs” the dialysis treatment floor, from 11/01/23 through 01/31/24 revealed the following: 1. A review of the glucometer for the dialysis treatment floor labeled “meter v2” for November revealed: a. On 11/13/23, the recorded acceptable low control range was 92-131, and the recorded low control was 19. b. On 11/01, 11/03, 11/09, 11/10, and 11/11 the log for “Meter v2” revealed the staff failed to check the low and high control. 2. A review of the glucometer for the dialysis treatment floor “Meter v2” for December revealed: a. On 12/24/23 the acceptable control was 96-128, the recorded control was documented as being 143. b. On 12/31/23 the acceptable low control should be 96-127, the recorded control was 128. c. On 12/01, 12/10, 12/11,12/13, 12/15, 12/19, and 12/22 for “meter v2” staff failed to check the low and high control. 3. A review of the glucometer for the treatment unit labeled “meter v2” for January revealed: a. On 01/20/24 the acceptable control was 94-126, and the recorded control was 130. b. On 01/06 the staff failed to check the low and the high control. A review of electronic “Blood Glucose Logs” for the Isolation room (ISO) from 11/01/23 through 01/31/24 revealed the following: 1. A review of the meter labeled “Meter v2-ISO” for November revealed: a. On 11/03/23 the acceptable low control was 97-131 the recorded control was 19. b. On 11/21/23 the acceptable low control was 95-127 the recorded control was 71. c. On 11/22/23 the acceptable low control was 97-131 the recorded control was 19. d. On 11/30/23 the staff failed to record the high and the low control. 2. A review of the December log for “Meter v2-ISO” revealed: a. On 12/02 the acceptable low control was 97-128 the recorded control was 130. b. On 12/07 the acceptable low control was 97-131 the recorded control was 19. c. On 12/23 the acceptable high control was 287-387 the recorded high control was 397. d. On 12/06, 12/15, 12/18, and 12/19 the staff failed to record the low control and the high control. 3. A review of the January log for “Meter V2-ISO” revealed: a. On 01/13 the acceptable low control was 95-127 the recorded control was 272. b. On 01/03, 01/04, and 01/18 the staff failed to record the low control and the high control. During an interview on 02/08/24 at 2:30 PM, the Chief Technician (CT) confirmed the findings and agreed the staff did not repeat the low-level and high-level control as required by the manufacturer’s instruction. A review of the facility’s policy titled, “Blood Glucose Monitoring Device,” dated 11/06/23, revealed, under the “Policy Training” section revealed, “Calibration and control testing shall be performed each operating day ...” A review of the “Embrace Pro” blood glucose monitoring system manufacturer instruction revision date 09/2020 revealed, “... if the control solution test results are out of the range, then repeat the test. If the results from the control solution tests continue to fall outside of the specified rage, do not use ...””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 26190 Based on record review, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for four of seven sampled in-center patients (Patient (P) 1, P 2, P3 and P5). Failure to follow the medical providers’ dialysis prescription has the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 77 patients receiving in-center dialysis treatments at this facility. Findings include: 1. A review of P1’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (ml/min). A review of two of six “Post Treatment” flowsheets from 01/24/24 through 02/05/24, in the EMR indicated the following: On 01/24/24, the BFR was documented at 400 ml/min from 10:34 AM until 11:00 AM and 12:00 PM until 2:41 PM. On 02/02/24, the BFR was documented at 300 ml/min from 10:22 AM until 12:32 PM, at 400 ml/min at 1:29 PM, and 375 from 2:07 PM until 2:37 PM. There was no documented rationale for the change to the prescribed BFR. 2. A review of P2’s EMR revealed a prescribed BFR of 400 ml/min and DFR (dialysate flow rate) of 800 ml/min. A review of one of six “Post Treatment” flowsheets from 01/25/24 through 02/06/24, in the EMR indicated the following: On 01/30/24, the DFR was documented at 500 ml/min from 9:39 AM until 10:59 AM and from 11:30 AM until 1:40 PM. There was no documented rationale for the change to the prescribed DFR. 3. A review of P3’s EMR revealed a prescribed BFR of 500 ml/min and DFR (dialysate flow rate) of 800 ml/min. A review of one of six “Post Treatment” flowsheets from 01/26/24 through 02/07/24, in the EMR indicated the following: On 02/02/24, the BFR was documented at 300 ml/min from 6:05 AM until 7:00 AM and at 450 ml/min from 7:37 AM until 9:30 AM. On 02/05/24, the BFR was documented at 475 ml/min at 6:05 AM, and at 450 ml/min from 6:35 AM until 9:35 AM. On 02/07/24, the BFR was documented at 450 ml/min from 6:30 AM until 9:39 AM. The DFR was documented at 500 ml/min from 6:30 AM until 9:39 AM. There was no documented rationale for the change to the prescribed BFR and DFR. 4. A review of P5’s EMR revealed a prescribed BFR of 400 ml/min and a DFR of 800 ml/min. A review of one of six “Post Treatment” flowsheets from 01/23/24 through 02/06/24, in the EMR indicated the following: On 01/27/24, the DFR was documented at 500 ml/min from 7:10 AM until 10:04 PM. On 02/01/24, the BFR was documented at 300 ml/min from 7:30 AM until 8:51 AM and at 350 ml/min from 9:20 until 9:58 AM. The DFR was documented at 500 ml/min from 7:30 AM until 9:58 AM. On 02/03/24, the BFR was documented at 300 ml/min from 8:03 AM until 9:35 AM. There was no documented rationale for the change to the prescribed BFR and DFR. During an interview on 02/09/24 at 2:30 PM, the Clinic Manager (CM) confirmed the above findings, stating the dialysis prescription must be met. The CM said if the patient cannot be run at the dialysis prescription the reason should be documented in the patient’s medical record. A review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “The purpose of this policy is to provide guidance to FKC (Fresenius Kidney Care) direct patient care staff on assessment and monitoring patients before, during and after treatment. Responsibility Direct patient care staff (RN [Registered Nurse], LPN [Licensed Practical Nurse]/LVN [Licensed Vocational Nurse], PCT [ Patient Care Technician]) ...During Treatment ...Document machine parameters and safety checks every 30 minutes ...Follow the steps below for monitoring patient and machine parameters during treatment: ...Step 1 ...Ultrafiltration Rate (UF) Monitor UF Rate ...Step 3 Machine Parameters ...Check machine setting 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 ...Step 4 Document any findings and interventions in the medical record ...””

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 26190 Based on medical record review, interview, and policy review, the facility failed to follow the patient’s plan of care by addressing the care provided by the interdisciplinary team and monitoring the patient’s medical status throughout the dialysis treatment for two of seven sampled in-center patients (Patient (P) 4 and P7). Failure to follow the plan of care had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 77 patients receiving in-center dialysis treatments at this facility. Findings include: 1. A review of P4’s electronic medical record (EMR) revealed patient safety checks were not completed within the 30-minute time intervals. A review of one of six “Post Treatment” flowsheets from 01/25/24 through 02/06/24, in the EMR indicated the following: On 02/06/24, a patient safety check was documented at 6:27 AM with the next one occurring at 7:21 AM, a total of 54 minutes between checks. On the same date, there was a patient safety check performed at 9:55 with the next one occurring at 10:44, a total of 49 minutes between checks. There was no documented rationale for the delayed safety checks. 2. A review of P7’s EMR revealed patient safety checks were not completed within the 30-minute time intervals. A review of two of six “Post Treatment” flowsheets from 01/25/24 through 02/06/24, in the EMR indicated the following: On 01/25/24, a patient safety check was documented at 1:30 PM with the next one occurring at 2:22 PM, a total of 52 minutes between checks. On 02/03/24, the patient safety check was documented at 12:55 PM with the next one occurring at 2:00 PM, a total of 65 minutes between checks. On the same date, there was a patient safety check performed at 2:00 PM with the next one occurring at 2:54 PM, a total of 54 minutes between checks. There was no documented rationale for the delayed safety checks. During an interview on 02/09/24 at 2:35 PM, the Administrator confirmed the above findings, stating he/she was unclear as to why the safety checks were not done within the 30-minute time period. A review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “The purpose of this policy is to provide guidance to FKC (Fresenius Kidney Care) direct patient care staff on assessment and monitoring patients before, during and after treatment. Responsibility Direct patient care staff (RN [Registered Nurse], LPN [Licensed Practical Nurse]/LVN [Licensed Vocational Nurse], PCT [ Patient Care Technician]) ...During Treatment ...Document machine parameters and safety checks every 30 minutes or more as needed but not to exceed 45 minutes ...Document machine parameters and safety checks every 30 or often as needed but not to exceed 45 minutes ...””

“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: 22676 Based on interview, Quality assessment and performance improvement (QAPI) meeting minutes, Technical audits, and policy review, the facility failed to conduct a thorough review of 2 out of 2 glucometer logs (treatment floor and Isolation room (ISO)) through their QAPI process in December 2023 and January 2024. Failure to review to identify issues and develop corrective action plans had the potential to cause harm to all 77 in-center hemodialysis patients receiving care at the facility. Findings include: A review of the Technical audit of the glucometer logs for November and December, under the section “Technical Notes” revealed the following: At the 12/20/23 QAPI Meeting, the report of the November data of the glucometer logs revealed only an issue with “expired dates and out-of-range results.” The audit failed to identify that the staff failed to record the high and low controls for “Meter v2” on 11/01, 11/03, 11/09, 11/10, and 11/11 and the staff failed to record the controls for meter “Meter V2-ISO” on 11/30/23. The minutes also failed to identify a corrective action plan and make the appropriate assignment for the person responsible for educating the staff regarding the plan and monitoring the results of the implementation of the plan. At the 01/17/24 QAPI Meeting, the report of the December data of the glucometer logs revealed that the glucometer’s low control was out of range. The audit failed to identify that the staff failed to record the high and low controls for “Meter v2” on 12/01, 12/10, 12/11,12/13, 12/15, 12/19, and 12/22 and “Meter v2-ISO” that the high control was also out of range and the staff failed to record the low control and the high control on 12/06, 12/15, 12/18, and 12/19. The minutes also failed to identify a corrective action plan and make the appropriate assignment for the person responsible for educating the staff regarding the plan and monitoring the results of the implementation of the plan. During an interview on 02/09/23 at 1:30 PM, the Facility Administrator confirmed the findings and agreed the QAPI Meeting failed to develop an effective corrective action plan to prevent recurrence of the staff failure to appropriately conduct the appropriate controls of the glucometers. A review of the Facility’s policy titled “Quality Assessment and Performance Improvement Program” dated 05/02/2022 stated that QAIP [Quality Assessment Improvement Program] is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes.”