Davita East Des Moines Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50072 Based on review of facility documents and staff interviews, the facility failed to ensure staff tested for and accurately documented the absence of residual disinfectant in the RO (reverse osmosis) system after disinfection of the RO system and prior to patient treatments. (See V219) The facility staff reported an in-center hemodialysis patient census of 40 inpatient center dialysis patients at the time of the Survey, the number of patients potentially affected by this deficient practice. This systemic failure and deficient practice resulted in the facility’s inability to ensure the safe provision of water and dialysate for ESRD (End Stage Renal Disease) patients. During the relocation and recertification survey, the survey team identified an Immediate Jeopardy (IJ) situation, a situation that places patients at risk for harm, related to Water and Dialysate Quality (42 CFR 494.40). The facility failed to provide documentation that reflected staff tested for the absence of residual disinfectant after disinfection of the Reverse Osmosis (RO) dialysis water treatment system was completed and prior to using the RO system for dialysis treatments. The survey team notified the Facility Administrator and Manager of Clinical Services of the Immediate Jeopardy on 12/04/24 at 3:15 pm. In response to the Immediate Jeopardy, the Facility Administrator and Manager of Clinical Services acted and put a Imediate Jeopardy removal plan in place. The survey team confirmed the immediate corrective actions were fully implemented on 12/05/24 at 10:33 am prior to the relocation and recertification survey exit date. However, a condition level deficiency remained for the Condition: Water and Dialysate Quality. In response to the Immediate Jeopardy (IJ), the facility Governing Body developed and implemented an IJ (Immediate Jeopardy) removal plan. The corrective action plan and implementation plan removed the IJ and included in summary: 1. The Biomedical Service Specialist (BSS), Facility Administrator (FA) and/or Manager of Clinical Services (MCS) conducted mandatory in-services for all clinical teammates starting on 12/3/2024 reviewing the facility policy associated with chemical residual disinfection testing prior to dialysis startup. Staff were required to attend the education and docuentation of attendance was recorded and verified by the facility Administrator. Teammates were also instructed in the process of verifying and documenting the results of the residual disinfection according to facility policy. 2. The Governing Body initiated that two (2) teammates will verify that the residual chemical test after the chemical disinfection of the CWP RO (Reverse Osmosis) system is completed and documented on the CWP Daily Water Log.”

“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: 50072 Based on review of facility policies and procedures, observations and staff interview, the facility failed to ensure staff performed infection control practices to minimize the spread of infections or bloodborne pathogens in the dialysis facility in accordance with the facility’s policy. The facility failed to ensure staff had disinfected the equipment located at the dialysis station in accordance with the facility’s policy and procedure. Failure to complete the disinfection process of the dialysis station could potentially place patients at risk for exposure to infection and other adverse outcomes. Failure to ensure cleaning and disinfection of items between patient treatments could potentially result in the transmission of bloodborne pathogens and other infection from one patient to another in the dialysis facility. The facility staff reported an in-center hemodialysis patient census of 40 at the time of the survey. Findings for observations on 2 of 2 patient treatment days (12/03/24 - 12/04/24) include: 1. Review of the facility’s policy titled “INFECTION CONTROL FOR DIALYSIS FACILITIES” Policy: 1-05-01 with a revision date of April 2023, reads in part “...DISINFECTION 12. b. Use an appropriate disinfectant such as 1:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. i. Disinfection should be completed by using a wiping motion with friction. ii. Sufficient disinfectant should be applied so that surfaces are visibly wet. iii. Surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time...13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g. dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel, top, front, sides of dialysis machine, touchscreens; countertops) ...14. Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient.” 2. Observation on 12/03/24 at 9:44 AM showed PCT (Patient Care Technician) A disinfecting dialysis treatment station #4. During the observation PCT A failed to wipe the connector arm of the television in the station. Further observation showed PCT A dropped the machine prime receptacle (a receptacle attached to the side of the dialysis machine to catch fluids) on the floor and failed to disinfect the external and internal surfaces of the receptacle before returning the receptacle to the top of the dialysis machine. Continued observation showed PCT A failed to disinfect external surfaces of the trash receptacle and the sharps container within the dialysis treatment station. 3. Observation on 12/03/24 at 9:53 AM showed PCT A disinfecting dialysis treatment station #3. PCT A failed to fully wipe down the treatment chair seat and seat back with disinfectant to cover all of the external surfaces of the dialysis treatment chair. PCT A also failed to wipe down the outside of the sharps container and the outside of the trash receptacle within the dialysis treatment station. Continued observation showed PCT A failed to wipe the counter area at the back of the treatment station with disinfectant. 4. Observation on 12/04/24 at 9:05 AM showed PCT A disinfecting dialysis treatment station #7. PCT A failed to completely wipe the external and internal surfaces of the prime bucket before returning it to the machine. PCT A also failed to wipe the external surface of the trash receptacle and sharps container within the dialysis treatment station. Continued observation showed PCT A failed to fully wipe down the seat and seat back of the treatment chair with disinfectant. 5. During an interview on 12/04/24 at 10:55 AM with the Facility Administrator and the Manager of Clinical Services, they acknowledged that in the above instances the facility did not follow the facility infection control policy.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 50072 Based on review of facility policies, document review and staff interviews, the facility failed to provide documentation to indicate staff were testing for the absence of residual disinfectant in the RO (Reverse Osmosis) system after disinfection and prior to the start of the following dialysis treatment day to ensure the system was safe to provide hemodialysis treatment to patients. Failure to ensure the absence of residual disinfectant in the RO system prior to hemodialysis use could lead to patient exposure to a chemical disinfectant and could lead to serious patient harm. The facility staff reported an in-center hemodialysis patient census of 40. Findings include: 1. Review of facility policy 1-17-02, DAILY WATER TREATMENT SYSTEM MONITORING, revision date April 2023 revealed: “3. Observations and test results listed on the ’ Daily Treatment Log ’ and in the IT Clinical System are entered each facility operating day prior to the use of the dialysis quality water for any process and the start of dialysis treatments ... 5. All observations and test results will be within the limits specified on the Daily Water Treatment Log. If observations or test results are found outside the specified limits, follow the instructions given on the Daily Water Treatment Log for the parameter(s) in question. In addition to following the log form instructions, the teammate completing the log will notify the Facility Administrator/designee and Biomed teammate assigned to the facility of any observation or test result found outside the limit specified on the Daily Water Treatment Log. 6. The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Treatment Log ... 7. A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory completion of this review, the licensed nurse initials and signs the log form where indicated.” 2. Review of facility policy CWP RO POST CHEMICAL DISINFECTION START UP PROCEDURE revealed: “2. Press the green START touch pad on the CWP Operator ’ s panel. 3. After approximately 1 minute, use a Minncare residual test strip and test the water flowing into the drain funnel on the right side of the CWP for the absence of PAA. 4. Document that the water is free of disinfectant on the Weekly water log sheet.” 3. Review of facility documentation titled, DAVITA DAILY WATER TREATMENT LOG, dated 10/28/24-12/02/24, revealed the following: a. A chemical disinfection of the RO system was initiated on 11/06/24 at 5:00 PM, however on 11/07/24, the next dialysis treatment day, line 43 the “Acceptable Limits” box, “Test for Chemical Residual,” was marked “NA” instead of “Y / N” to indicate whether the chemical residual test was acceptable or unacceptable for system use. b. A chemical disinfection of the RO system was initiated on 11/13/24 at 4:00 PM, however on 11/14/24, the next dialysis treatment day, line 43 “Test for Chemical Residual,” was left blank instead of “Y / N” to indicate whether the chemical residual test was acceptable or unacceptable for system use. c. A chemical disinfection of the RO system was initiated on 11/20/24 at 3:55 PM, however on 11/21/24, the next dialysis treatment day, line 38 “Test for Chemical Residual,” was marked “NA” instead of “Y / N” to indicate whether the chemical residual test was acceptable or unacceptable for system use. d. A chemical disinfection of the RO system was initiated on 11/27/24 at 4:20 PM, however on 11/28/24, the next dialysis treatment day, line 38 “Test for Chemical Residual,” was marked “NA” instead of “Y / N” to indicate whether the chemical residual test was acceptable or unacceptable for system use. e. Further review of the log showed that the RO system was placed into Chemical Disinfection on 11/06/24, 11/13/24, 11/20/24 and 11/27/24 however the facility staff documented “NA” or left blank on each of the respective following days, prior to treatments, instead of “Y / N” to indicate whether the chemical residual test was acceptable or unacceptable for system use. 4. During an interview with the Biomedical technician on 12/02/24 at 10:00 am, they reviewed the Daily Water Treatment Logs and advised that the ’ NA ’ on the form suggested that staff needed to be retrained on how to properly document on the logs. 5. During an interview with PCT H and the FA on 12/03/24 at 10:45 am, they confirmed that there is a weekly loop disinfection that is completed after treatments on Wednesdays. Thursday mornings are when residual disinfectant is manually tested and the value of the test is supposed to be documented on the Daily Water Log, not “NA”.”