322523 North Albuquerque Dialysis Center (Fmc)

“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 the wall boxes (dispensing outlets) at six of eight dialysis (Station 1, 2, 3, 4, 5, and 25) stations observed were clean and free of a build-up of white crystals. This deficient practice had the potential to cause bacteria to grow in the wall boxes and could potentially affect the 106 patients receiving in-center hemodialysis at the facility. Findings include: During an observation of all wall boxes on 07/22/24 at 10:45 AM, at Stations 1, 2, 3, 4, 5 and 25, revealed a white sediment build-up on the wall boxes and the outside facing of the boxes. Station 1 and 25 had thick layer of build of white crystals in the bottom of the box. During an interview on 07/22/24 at 1:30 PM Clinic Manager 3 confirmed the above findings. Review of the facility’s policy titled, “Cleaning and Disinfection of the Dialysis Station”, dated 09/05/23, indicated, “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. All surfaces shall be surface disinfected with 1:100 bleach solution. Special attention should be given to removing build-up and/or cleaning splatter and spray of concentrate solution. If concentrate leaks are noted at the wall box, staff should notify biomedical services for repair.” Review of the “CDC Dialysis Safety” located on the CDC website at www.cdc.gov titled, “Wall boxes and Drains” page last reviewed: October 25, 2019, 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.””

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 22676 Based on observation, interview, review of the “Daily Water Treatment Logs,” and review of facility policy, the facility failed to ensure the staff monitored the end of day hardness of water quality for six days of 60 days reviewed (05/22/24, 06/03/24, 06/08/24, 06/09/24, 07/12/24 and 07/17/24). This deficient practice had the potential to affect the water quality of the all in-center hemodialysis patients receiving treatment and staff at this facility. Findings include: Review of the facility’s electronic “Daily Water Treatment Logs titled Water Softener” from 06/01/24 through 07/20/24 located in the electronic waterlogs, revealed the facility failed to conduct the end of day hardness on 05/06/24, 05/10/24, 05/31/24 and 06/11/24. The area to document the end of the day hardness was left blank. During an interview on 07/22/24 at 3:28 PM, Clinic Manager 3 confirmed the staff are required to conduct and document, the end of day hardness (a test to confirm the water hardness does not exceed the required limits) on the daily water treatment log at the end of each treatment day. He/She confirmed that on 05/22/24, 06/03/24, 06/08/24, 06/09/24, 07/12/24 and 07/17/24 the staff failed to document evidence of the end of day hardness. A review of the facility’s policy titled, “Water Softener” dated 05/03/23, revealed, “Hardness levels post water softener at the beginning of each operational day and at the end of each operational day.””

“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, interview, review of the “Daily Water Treatment Logs,” and review of facility policy, the facility failed to ensure the staff monitored the chlorine after the first carbon tank every four hours for five days of 47 days reviewed (05/01/24, 05/04/24, 05/06/24, 05/24/24 and 06/19/24). This deficient practice had the potential to affect all 106 patients receiving dialysis at the facility by exposing them to harmful chlorine. Findings include: Review of the facilities electronic “Daily Water Treatment Logs titled Post Worker Carbon Tank” from 05/01/24 through 06/30/24, located in the electronic waterlogs, revealed the facility failed to conduct the chlorine test every four hours as required by Federal Regulations and facility policy. 1. On 05/01/24, staff conducted the chlorine test at 1:01 PM and did not recheck the chlorine until 6:25 PM. Five hours and 24 minutes later. 2. On 05/04/24, staff conducted the chlorine test at 8:32 AM and did not recheck the chlorine until 1:01 PM. Four hours and 29 minutes later. 3. On 05/06/24, staff conducted the chlorine test at 11:00 AM and did not recheck the chlorine until 3:22 PM. Four hours and 22 minutes later. 4. On 06/19/24, staff conducted the chlorine test at 4:57 AM and did not recheck the chlorine until 8:54 PM. 14 hours and 57 minutes later. 5. On 06/24/24, staff conducted the chlorine test at 8:53 AM and did not recheck the chlorine until 1:53 PM. Five hours later. During an interview on 07/22/24 at 3:15 PM, Clinic Manager 3 and the Biomedical Technician 6 confirmed staff are required to conduct the chlorine test every four hours. They both confirmed the staff did not conduct the chlorine test as required every four hours. Clinic Manager 2 stated they had recently identified the issue and implemented a corrective action plan on 06/20/24 and revised the plan on 07/10/24. which will be reviewed in the July Quality meeting. During the interview, a copy of the corrective action plan was provided for review. A review of the facility’s policy titled, “Carbon Filtration Monitoring for Incenter Water System Policy” dated 11/07/22, revealed, “When to Test ...at a minimum of every four hours.””

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 22676 Based on interview, document review, review of manufacturer’s instructions, and policy review, the facility failed to change the Granuflo (a type of acid base used in dialysis treatments) mixing tanks filter after the sixth batch. This had the potential to affect all 106 patients receiving in-center hemodialysis patients receiving care at the facility. Findings include: Review of the Granuflo Mixing Log for the month of June 2024 revealed there were a total of 12 batches made and there was no documented evidence the Granuflo filter was changed. Observation in the water room on 07/22/24 at 10:30 AM, revealed the Granuflo mixing filter was not dated. During an interview on 07/22/24 at 10:30 AM, the Biomedical Technician 6 stated that he/she changes the filter after the sixth batch is made and the staff are supposed to document the filter change. The Biomedical Technician 6 confirmed there was no documented evidence the mixing filter was changed. Review of the facility’s policy titled; “Acid Concentrate Distribution System Maintenance” dated 05/23/2022 indicates to follow the “manufactures instructions.” Review of the manufacturer’s instructions dated 2016 states “the filter should be changed after mixing 6 batches.””

“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 review of glucometer logs, interview and policy review, the facility failed to ensure the glucometer high and low controls were conducted for four of 72 clinic operating days reviewed. This deficient practice had the potential to affect all 106 patients receiving care at the facility by failure to conduct controls of the glucometer for use in an emergency. Findings include: Review of Blood Glucose logs from 06/01/24 through 07/23/24 revealed staff failed to document the low and high glucometer controls for 05/08/24, 05/09/24, 06/19/24 and 07/06/24. During an interview with the Clinic Manager 3 on 07/23/24 at 9:00 AM, he/she confirmed staff failed to conduct the high and low control on 05/08/24, 05/09/24, 06/19/24 and 07/06/24. Review of the facility’s policy titled “Blood Glucose Monitoring Device” dated “11/06/2023” indicated, “Calibration and control testing shall be performed each operating day that patients are present ...””

“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: 22676 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 nine of 10 sampled in-center dialysis patients (Patient (P) 1, P2, P4, P5, P6, P7, P8, P9, and P10). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 106 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P1’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (ml/min) and a Dialysate Flow Rate (DFR) of 500 ml/min. Review of two of two “Post Treatment” flowsheets from 07/11/24 through 07/15/24 in the EMR indicated the following: a. On 07/11/24, the DFR was documented at 800 ml/min from 6:12 AM until 10:14 AM. b. On 07/17/24, the DFR was documented at 800 ml/min from 2:49 PM until 5:35 PM. There was no documented rationale for the change to the prescribed DFR. 2. Review of P2’s EMR revealed a prescribed BFR of 350 ml/min and a DFR of 600 ml/min. Review of one of two “Post Treatment” flowsheets from 07/09/24 through 07/18/24 in the EMR indicated the following: a. On 07/18/24 the BFR was documented at 300 ml/min from 1:31 PM until 2:01 PM. There was no documented rationale for the change to the prescribed BFR. 3. Review of P4’s EMR revealed a prescribed BFR of 350 ml/min and a DFR of 700 ml/min. Review of one of six “Post Treatment” flowsheets from 07/09/24 through 07/20/24 in the EMR indicated the following: a. On 07/17/24 the DFR was documented at 800 ml/min from 7:31 AM until 3:50 PM. There was no documented rationale for the change to the prescribed DFR. 4. Review of P5’s EMR revealed a prescribed BFR of 400 ml/min and a DFR of 500 ml/min. Review of one of four “Post Treatment” flowsheets from 07/10/24 through 07/20/24 in the EMR indicated the following: a. On 07/20/24 the DFR was documented at 800 ml/min from 11:51 AM until 9:04 AM. There was no documented rationale for the change to the prescribed DFR. 5. Review of P6’s EMR revealed a prescribed BFR of 350 ml/min and a DFR of 700 ml/min. Review of one of six “Post Treatment” flowsheets from 07/09/24 through 07/20/24 in the EMR indicated the following: a. On 07/20/24 the DFR was documented at 800 ml/min from 12:29 PM until 3:57 PM. There was no documented rationale for the change to the prescribed DFR. 6. Review of P7’s EMR revealed a prescribed BFR of 300 and a prescribed DFR of autoflow 2.0 which would be 600 ml/min and a DFR of 700 ml/min. Review of two of six “Post Treatment” flowsheets from 07/08/24 through 07/19/24 in the EMR indicated the following: a. On 07/08/24 the BFR was ran at 350 ml/min and the DFR at 700 ml/min was documented from 3:45 PM until 8:05 PM. b. On 07/15/24 the BFR was ran at 350 ml/min and the DFR at 700 ml/min was documented from 2:31 PM until 9:43 PM. There was no documented rationale for the change to the prescribed BFR. 7. Review of P8’s EMR revealed a prescribed BFR of 350 ml/min and a DFR of 500 ml/min. Review of one of two “Post Treatment” flowsheets from 07/18/24 through 07/20/24 in the EMR indicated the following: a. On 07/20/24 the DFR was documented at 800 ml/min from 1:37 PM until 2:47 PM. There was no documented rationale for the change to the prescribed DFR. 8. Review of P9’s EMR revealed a prescribed BFR of 425 ml/min and a DFR of 500 ml/min. Review of three of three “Post Treatment” flowsheets from 07/11/24 through 07/18/24 in the EMR indicated the following: a. On 07/11/24 the DFR was documented at 800 ml/min from 12:05 PM until 2:31 PM. b. On 07/16/24 the DFR was documented at 800 ml/min from 1:33 PM until 2:08 PM. c. On 07/18/24 the BFR was documented at 375 ml/min from 1:08 until 1:35 PM and the at 300 from 1:35 PM until 5:37 PM. There was no documented rationale for the change to the prescribed BFR and DFR. 9. Review of P10’s EMR revealed a prescribed BFR of 375 ml/min and a DFR of 800 ml/min. A review of five of six “Post Treatment” flowsheets from 07/08/24 through 07/19/24 in the EMR indicated the following: a. On 07/08/24 the BFR was documented at 350 ml/min from 1:05 PM until 2:31 PM. b. On 07/10/24 the BFR was documented at 350 ml/min from 12:36 PM until 2:35 PM. c. On 07/12/24 the BFR was documented at 350 ml/min from 12:35 PM until 2:30 PM. d. On 07/17/24 the BFR was documented at 350 ml/min from 12:30 PM until 1:04 PM. and from 1:04 PM until 2:29 PM it was documented at 300 ml/min. e. On 07/19/24 the BFR was documented at 300 ml/min from 12:37 PM until 2:31 PM, and from 3:31 PM until 3:07 PM it was documented at 350 ml/min. There was no documented rationale for the change to the prescribed BFR. During an interview on 07/23/24 at 2:15 PM, the Clinic Manager 3 confirmed the above findings and confirmed that the staff did not follow the physician’s order for dialysis treatment. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Check the prescribed blood flow rate is being achieved or the reason is documented in the medical record if unable to meet prescribed flow rate. Check dialysate flow rate setting is correct, and the correct prescribed flow is being ...””