Davita Paxton Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 39848 Based on review of facility policy and procedures, an observational tour of the facility, review of dialysis delivery system cleaning and disinfection logs, and an interview with the clinic administrator, the clinic failed to ensure a sanitary environment (Tag V 0111); failed to ensure proper cleaning and disinfection of Fresenius dialysis delivery systems through complete and accurate logs (Tag V 0122). This CONDITION is not met as evidenced by, No immediate jeopardy situation was identified. Findings Include: Cross Reference: 42CFR 494.30 Ic-sanitary environment 42 CFR 494.30(a)(4)(ii) Ic-Disinfect surfaces/equip/written protocol The cumulative effect of these systematic problems resulted in the facility’s inability to ensure that a sanitary and safe environment was provided for patients.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 39848 Based on review of facility policy and procedures, an observational tour of the facility, review of facility daily logs, and an interview with the facility administrator, the facility failed to ensure a safe, functional environment for patients and failed to ensure dialysis equipment was maintained per manufacturer ’ s directions for use. This CONDITION is not met as evidenced by, but did not result in Immediate Jeopardy: Findings Include: Cross Reference: 402-494.60(a) Pe-building-construct/maintain for safety 403-494.60(b) Pe-equipment maintenance-manufacturer ’ s Dfu 404-494.60(c)(1) Pe-pt care environment-sufficient space The cumulative effect of these systematic problems resulted in the facility’s inability to ensure that a safe and functional environment was provided for patients.”

“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: 39848 Based on review of facility policies and procedures, observations, and interview with Facility Administrator, it was determined the facility failed to ensure a sanitary environment during two (2) of eleven (11) patient care observations. OBS #1-#2. Findings include: Observations of care conducted, during survey dates 8/6/24, 8/7/24 and 8/8/24, revealed the following: Observation #1: 8/8/24 between 9:30 AM-09:35 AM: EMP #6 was observed discontinuing treatment for MR # 5 and did not perform glove change after touching patient belongings by folding patient ’ s blanket and placing in patient ’ s bag then started to disconnect patient ’ s blood lines. Observation #2: 8/8/24 between 9:50 AM-10:00 AM: EMP #6 was observed initiating treatment for patient with a central venous catheter (CVC) and did not perform glove change after moving biohazard sharps container closer to patient then touched the clean catheter supplies. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”

“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: 39848 Based on review of Fresenius dialysis delivery system clean and disinfect logs, policies and procedures, and an interview with the facility administrator, the facility failed to ensure patient safety by proper cleaning and disinfection of Fresenius dialysis delivery systems and failed to maintain completed and accurate logs for eleven (11) of eleven (11) observations (OBS # 1- # 11) Findings include: Review of Davita Incenter Hemodialysis policies and procedures: title: Fresenius dialysis delivery system cleaning and disinfection policy on 8/19 at 11:30 AM revealed: “ Purpose: To promote patient safety by cleaning and disinfection of Fresenius dialysis delivery systems. “ Policy: 3. All facilities are to follow manufacturer ’ s procedures for cleaning and chemical disinfection; examples of cleaning/disinfection procedures and intervals: cleaning/disinfection intervals depend on the facility ’ s operations; Procedure: Heat disinfection: each treatment day (unless chemical disinfect day); citric acid, vinegar rinse: each treatment day; bleach or peracetic acid disinfection: weekly; peracetic acid or integrated heat end to end disinfection: monthly; 6. Facilities will develop a specific dialysis delivery system cleaning and disinfection log in conjunction with the Biomedical department and with approval by the Biomed Operations manager (BOM). Cleaning and disinfection of dialysis delivery systems will be documented on this log; 7. At a minimum, the facility specific log must include the following elements: serial number, date procedure provided, type of procedure provided: cleaning/descaling, disinfection (chemical and/or heat), post chemical rinse residual test, verification of negative chemical residual test just prior to next use. Status of equipment, teammate initials, signature/initials legend; 12. Equipment should not be used for patient treatments until results from residual bleach test has reached a level of less than or equal to one half parts per million (0.5 ppm). “ Observation (OBS) # 1: Clean and disinfect log reveals that facility has twenty (20) machines. OBS # 2: Documentation for AM residual and ending residual are noted as not applicable (N/A) instead of negative (NEG) for month of July and August for twenty-eight of twenty-eight (28) observations. (OBS # 1- # 28) Observation (OBS) # 1: On 7/2/24, all twenty (20) machines having ending residual marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 2- # 3: On 7/8/24 and 7/9/24, both AM residual and ending residuals are marked as N/A except for the machines as follows: # 5-2K0S-178355 # 15-2K0S-178560 # 19-2K0S-178618 OBS # 4- # 7: On 7/10-13/24, all twenty machines (20) have AM and ending residuals marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 8: On 7/15/24, Ending residuals marked as N/A except for machines as follows: # 1-2K0S-178269 # 18-2K0S-178592 # 19-2K0S-178618 OBS # 9: On 7/16/24, both AM residual and ending residuals are marked as N/A except for the machines as follows: # 6 -2K0S-178371 # 16-2K0S-178577 # 19-2K0S-178618 OBS # 10: On 7/17/24, all machines have both AM and ending residuals marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 11: On 7/19/24, all twenty (20) machines having ending residual marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 12: On 7/20/24, both AM residual and ending residuals are marked as N/A except for the machines as follows: # 19-2K0S-178618 OBS # 13: On 7/22/24, both AM residual and ending residuals are marked as N/A except for the machines as follows: # 16-2K0S-178577 OBS # 14- # 15: On 7/23/24 and 7/24/24, all twenty (20) machines having ending residual marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 16- # 17: On 7/26/24 and 7/27/24, all twenty (20) machines having ending residual marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 18- # 20: On 7/29-7/31/24, all twenty (20) machines having ending residual marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 21-# 22: On 8/2/24 and 8/3/24, all twenty (20) machines having ending residual marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 23-# 25: On 8/5-8/7/24, all twenty (20) machines having ending residual marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 26- # 27: On 8/9/24 and 8/10/24, all twenty (20) machines having ending residual marked as N/A. # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 28: On 8/12/24, Ending residuals marked as N/A except for machines as follows: # 16-2K0S-178577 # 19-2K0S-178618 OBS # 3: Two (2) days on the July logs are noted as 7/3/24. OBS # 4: On 7/2/24, only three (3) out of twenty (20) machines as documented as not in use, the remaining seventeen (17) machines have no documentation of descaling with citric acid (CA). Machine number and serial number for the seventeen (17) machines as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 18-2K0S-178592 # 20-OK0S-163589 OBS # 5: On first documented 7/3/24, only three (3) out of twenty (20) machines as documented as not in use, the remaining seventeen (17) machines have no documentation of descaling with citric acid and disinfection with bleach, heat or peracetic acid for machine number and serial number as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 20-OK0S-163589 OBS # 6: On the second day documented as 7/3/24, none of the machines have descaling with citric acid, disinfection with bleach, heat or peracetic acid, residual and initials noted. Twenty (20) Machine and serial number as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 7: On 7/4/24, descaling with citric acid and residuals have no documentation for all twenty (20) machines. Four (4) machines are documented as not in use with negative AM residuals and bleach disinfection with staff initials. Twenty (20) machines have no descaling with CA and residuals. Machine and serial number as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 Sixteen (16) machines have no disinfection or staff initials. Sixteen (16) machines with no bleach, heat or peracetic acid or staff initials for machine and serial number as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 14-2K0S-178537 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 20-OK0S-163589 OBS # 8: On 7/5/24, twenty (20) machines not documented as being descaled with citric acid. Machine and serial number as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 9: On 7/6/24, all twenty (20) machines have no residuals documented. Machine number and serial number as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 10: On 7/10/24, no documentation of descaling with citric acid to any of the twenty (20) machines. Machine number and serial number as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 OBS # 11: On 7/11/24, no documentation of descaling with citric acid to any of the twenty (20) machines. Machine number and serial number as follows: # 1-2K0S-178269 # 2-2K0S-178328 # 3-2K0S-178334 # 4-2K0S-178341 # 5-2K0S-178355 # 6 -2K0S-178371 # 7-2K0S-178377 # 8-2K0S-178378 # 9-2K0S-178382 # 10-2K0S-178395 # 11-2K0S-178503 # 12-2K0S-178508 # 13-2K0S-178532 # 14-2K0S-178537 # 15-2K0S-178560 # 16-2K0S-178577 # 17-2K0S-178589 # 18-2K0S-178592 # 19-2K0S-178618 # 20-OK0S-163589 Facility’s biomedical technician has identified the trends with the logs not having complete and accurate documentation and has been discussed in the facility’s Quality Assurance and Performance Improvement (QAPI) meetings in May which was signed by Facility Administrator on 6/17/24 and June 2024 which was noted by Facility Administrator with just date of July 2024. Facility does have a corrective action plan in place with minimal improvement noted in documentation of July or August logs. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 39848 Based on review of daily water treatment log and interview with clinic administrator, the facility failed to ensure proper operation and reliability of the dialysis salt brine tank for one (1) of one (1) observation. (Observation # 1) Findings: Review of Davita Incenter Hemodialysis polices and procedures: title: Daily water treatment system monitoring on 8/19 at 11:00 AM revealed: “ Purpose: To verify the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters. “ ; Policy: “ 1. All observations and test results must be recorded on the approved daily water treatment log ...; 3. Observations and test results listed on the daily water treatment log ...are entered each facility operating day prior to the use of dialysis quality water for any process and the start of dialysis treatments, except for hardness testing, done at the end of the treatment day.; 5. All observations and test results will be within the limits specified ....if observations or test results are found outside the specified limits, follow the instructions given on the daily 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 ...; 6. The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the daily waterlog. A separate entry of time and initials is provided for the teammate performing end of day hardness testing; 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 where indicated. “ Observation # 1: Salt level entry for the Brine tank marked as “no” and no other documentation that salt was added to the brine tank on 8/5/24. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”

“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: 39848 Based on review of daily water treatment log and interview with clinic administrator the facility failed to ensure overall effectiveness of the dialysis water softener for one (1) of one (1) observation. (Observation # 1) Findings: Review of Davita Incenter Hemodialysis polices and procedures: title: Daily water treatment system monitoring on 8/19 at 11:00 AM revealed: “ Purpose: To verify the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters. “ ; Policy: “ 1. All observations and test results must be recorded on the approved daily water treatment log ...; 3. Observations and test results listed on the daily water treatment log ...are entered each facility operating day prior to the use of dialysis quality water for any process and the start of dialysis treatments, except for hardness testing, done at the end of the treatment day.; 5. All observations and test results will be within the limits specified ....if observations or test results are found outside the specified limits, follow the instructions given on the daily 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 ...; 6. The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the daily waterlog. A separate entry of time and initials is provided for the teammate performing end of day hardness testing; 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 where indicated. “ Observation # 1: End of day Hardness test result on 7/1/24 is unreadable. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 39848 Based on review of daily water treatment log, bicarb system daily rinse log, Phoenix meter logs and an interview with the facility administrator, the facility failed to ensure proper operation and reliability of the dialysis water system and failed to maintain complete and accurate logs for dialysis water and equipment for twenty (20) of twenty (20) observations. (Observation # 1- # 20) Findings include: Review of Davita Incenter Hemodialysis polices and procedures: title: Daily water treatment system monitoring on 8/19 at 11:00 AM revealed: “ Purpose: To verify the dialysis water system operates safely and reliably through daily observations and/or testing of specific component performance parameters. “ ; Policy: “ 1. All observations and test results must be recorded on the approved daily water treatment log ...; 3. Observations and test results listed on the daily water treatment log ...are entered each facility operating day prior to the use of dialysis quality water for any process and the start of dialysis treatments, except for hardness testing, done at the end of the treatment day.; 5. All observations and test results will be within the limits specified ....if observations or test results are found outside the specified limits, follow the instructions given on the daily 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 ...; 6. The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the daily waterlog. A separate entry of time and initials is provided for the teammate performing end of day hardness testing; 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 where indicated. “ Review of Davita Incenter Hemodialysis policies and procedures: Facility Specific procedure: Paxton Dialysis # 05025; title: Better water dual tank bicarb mixing and delivery system nightly rinsing on 8/19 at 11:30 AM revealed: Note: “ Do not attempt to disinfect or clean the distribution loop while patients are connected to central bicarb loop. Validate that all patients are off central loops, prior to cleaning and/or disinfecting. “ ; Note: “ This procedure must be performed at the end of each treatment day. “ ; Procedure: “ 14. Complete rinse log; Rationale: for proper documentation. “ Review of Davita Incenter Hemodialysis policies and procedures: title: Phoenix meter disinfection and calibration verification on 8/19 at 12:20 PM revealed: Notes: “ The Phoenix meter is disinfected and verified prior to daily use. The outside of Phoenix meters must be disinfected after use prior to returning the meter to the storage location. “ Observation (OBS) # 1: No initials of license nurse to verify completeness of log and results are within acceptable limits on 7/11/24. OBS # 2: Feed water temperature documented as eighty-seven (87) degrees Fahrenheit which is two (2) degrees higher than acceptable temperature of eighty-five (85) degrees and no documentation that biomed was contacted for direction or assistance on 7/15/24. OBS # 3: Feed water temperature is unreadable on 8/6/24. OBS # 4: Bicarb system daily rinse log was not completed for 7/1/24. OBS # 5: Bicarb daily rinse log was not completed for 7/9/24. OBS # 6: Phoenix meter # 1 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/2/24. OBS # 7: Phoenix meter # 1 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/5/24. OBS # 8: Phoenix meter # 1 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/8/24. OBS # 9: Phoenix meter # 1 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/11/24. OBS # 10: Phoenix meter # 1 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/31/24. OBS # 11: Phoenix meter # 2 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/2/24. OBS # 12: Phoenix meter # 2 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/5/24. OBS # 13: Phoenix meter # 2 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/8/24. OBS # 14: Phoenix meter # 2 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/11/24. OBS # 15: Phoenix meter # 2 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/31/24. OBS # 16: Phoenix meter # 3 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/2/24. OBS # 17: Phoenix meter # 3 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/5/24. OBS # 18: Phoenix meter # 1 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/8/24. OBS # 19: Phoenix meter # 1 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/11/24. OBS # 20: Phoenix meter # 1 revealed no documentation that the meter was cleaned and no initials of the staff who cleaned it on 7/31/24. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”

“INVENTORY CONTROL CFR(s): 494.50(b)(1) 9.2 Inventory control Reprocessing supplies should be used on a first-in, first-out basis, and outdated supplies should be identified and discarded. This Standard is not met as evidenced by: 39848 Based on reviews of observations, facility policy, and an interview with the facility administrator, the facility failed to ensure proper inventory control for seven (7) of seven (7) observations (Observation #1-#7). Findings include: Review of Davita inc. Incenter Hemodialysis Policies and Procedures: Title: Medication Policy: “ Purpose: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic preparation of all medications; Policy: 1. The Facility Administrator/designee is responsible for supervising the handling, storing, disposing, administering, and controlling of medications and performs monthly audit and inventory; 13. All open or unopened medication packages (i.e. vials, ampules, etc) are stored according to the manufacturer ’ s directions. Do not use any medication that has been stored improperly or has expired; 30. All medications in the facility are checked monthly for expiration dates; 32. Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations. “ Review of Davita inc. Incenter Hemodialysis Policies and Procedures: Title: “ Infection Control for dialysis facilities: “ Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment.; Policy: The Center for Disease Control (CDC) recommendations for preventing transmission of infections among chronic hemodialysis patients (dialysis precautions) will be followed when caring for all patients. Supplies: 8. Supplies will be stored in a manner that maintains their integrity. b. expiration date and package integrity will be verified prior to use. Observations conducted in the center ’ s laboratory area on 8/6/24 between approximately 11:20 AM-11:30 AM revealed the following: Observation (OBS) #1 revealed: Twenty-five (25) Serim Guardian blood leak test strips with expiration date of 9/30/2023. OBS #2 revealed: Total of four (4) blood culture kits with two (2) bottles of aerobic plus and two (2) bottles of anaerobic lytic with expiration date of 5/27/2024 and 6/12/2024 for two (2) blood culture kits and one (1) bottle of aerobic plus and anaerobic lytic with expiration date of 8/1/2024. OBS #3 revealed: One (1) BD vacutainer urine complete cup kit with culture and sensitivity (C&S) preservative plus urine tube and urinalysis preservative plus conical urine tube with expiration date of 6/30/2024. OBS #4 revealed: One (1) bottle of Purell Hand sanitizer with expiration date of 9/30/2023. Observations conducted in the center ’ s water treatment room on 8/8/24 between approximately 10:15 AM and 10:45 AM revealed the following: OBS #5 revealed: One (1) bottle of Purell Hand sanitizer with expiration date of 9/30/2023. OBS #6 revealed: Two (2) bottles of RPC ultra low total chlorine test strips with expiration date of 7/31/24. OBS #7 revealed: Two hundred (200) Stericheck total chlorine reagent powder pillows with expiration date of 6/30/24. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”

“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: 39848 Based on observations, review of facility’s checklists, policies/procedures, and an interview with the Facility Administrator; the facility failed to maintain the integrity of the walls and the floors within the dialysis treatment area for six (6) of twelve (12) observations. OBS #1-#6. Findings include: OBS #1 completed 8/6/24 at 11:00 AM, paint chipping of walls at the base by the water connection access drains for dialysis station #1. OBS #2 completed 8/6/24 at 11:05 AM, Cracked and chipped pieces of wood on multiple areas of the nurse ’ s station. OBS #3, #4 and # 5 completed 8/6/24 between 11:05 AM-11:40 AM, Rust colored water stains and cracked pieces of wood noted in both dirty sinks on treatment floor and the sink in the isolation room. Door handles to both dirty sinks were both noted to have rust. OBS # 6 completed 8/6/24 between 10:55 AM-11:50 AM, multiple areas of wall molding loose behind treatment stations throughout the treatment room floor. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”

“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: 39848 Based on review of refrigerators/freezer logs and interview with clinic administrator the facility failed to ensure proper maintenance/functioning of equipment for nineteen (19) of nineteen (19) observations. (Observation #1- #19) Findings include: Review of Davita incenter hemodialysis policies and procedures on 8/19 at approximately 12:30 PM revealed: policy 1-06-06: title: medications requiring refrigeration: Purpose: “ To provide guidance for the storage and management of medications requiring refrigeration. “ Policy: “ 3. The refrigerator is checked during facility normal operating hours, by a licensed nurse teammate or designee. Checks will be documented on the Medication refrigerator management log. A. Twice daily temperature checks ... “ i. “ Verify that the temperature remains between two (2) degrees Celsius and eight (8) degrees Celsius (thirty-six (36) degrees Fahrenheit and forty-six (46) degrees Fahrenheit. “ ; d. “ Temperature excursions and issues noted during daily check will be noted on log with actions taken and outcome(s) ... “ Review of Medication refrigerator management log on 8/12/24 at approximately 1:00 PM revealed: Daily refrigerator check: “ Medication placed near corner of refrigerator, no expired medication, refrigerator cleanliness, bureau of laboratories (BOL) buffered probe placed near corner of refrigerator, water bottles, in place according to policy, if required, lock on refrigerator or in a room that locks, do not unplug sign by refrigerator power source. “ Observation (OBS) #1: Lab refrigerator: Temperature reading documented as one and eight tenths (1.8) degrees Celsius on 8/1/24 with no documentation of action taken for out-of-range temperature. OBS # 2: Medication fridge # 1: no initials of staff who completed daily refrigerator check on 7/2/24. OBS # 3: Medication fridge # 1: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/5/24. OBS # 4: Medication fridge # 1: no initials of staff who completed daily refrigerator check on 7/7/24. OBS # 5: Medication fridge # 1: no AM temperature check completed on 7/8/24. OBS # 6: Medication fridge # 1: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/9/24. OBS # 7: Medication fridge # 1: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/18/24. OBS # 8: Medication fridge # 1: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/26/24. OBS # 9: Medication fridge # 1: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/28/24. OBS # 10: Medication fridge # 2: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/5/24. OBS # 11: Medication fridge # 2: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/8/24. OBS # 12: Medication fridge # 2: no AM or PM temperatures documented, daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/9/24. OBS # 13: Medication fridge # 2: AM temperature documented as one and eight tenths (1.8) degrees Celsius on 7/11/24 and PM temperature documented as nine and nine tenths (9.9) degrees Celsius with no documentation of action taken for out-of-range temperature for either AM or PM temperature. OBS # 14: Medication fridge # 2: no AM temperature documented, daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/17/24. OBS # 15: Medication fridge # 2: AM temperature documented as nine (9) degrees Celsius on 7/18/24 with no documentation of action taken for out-of-range temperature for AM temperature and daily refrigerator check not marked as completed with no initials of staff who completed the check on 7/18/24. OBS # 16: Medication fridge # 2: PM temperature documented as eight and three tenths (8.3) degrees Celsius on 7/23/24 with no documentation of action taken for out-of-range temperature for PM temperature. OBS # 17: Medication fridge # 2: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/26/24. OBS # 18: Medication fridge # 2: daily refrigerator check not marked as completed and no initials of staff who completed the check on 7/29/24. OBS # 19: Medication fridge # 2: daily refrigerator check not marked as completed and no initials of staff who completed the check on 8/9/24. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”

“PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE CFR(s): 494.60(c)(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. This Standard is not met as evidenced by: 39848 Based on observations and an interview with the facility administrator, it was determined the facility failed to ensure adequate space between clean sinks, sharps containers and dialysis chairs to prevent cross-contamination for one (1) observation (Observation #1). Findings include: Observation #1: On 8/6/2024 at approximately 10:55 AM patient wheelchair was blocking clean sink. An interview conducted with the Facility Administrator on 8/12/24 at approximately 4:10 PM confirmed the above findings.”