Davita Bluemound Dialysis

“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: 29972 Based on observation, record review, and interview staff failed to clean and disinfect all the equipment at the dialysis station between patients to prevent potential cross contamination in 5 of 20 stations (Station (St) #3, 6, 8, 10, 11), and 1 of 1 observation of used equipment (hemostat clamps), in a total sample of 20 stations observed and 1 container of “dirty” equipment observed; failed to label the bleach solution to ensure it is effective for use in 2 of 2 observations of bleach solution (1:100 and 1:10 bleach solution), in a total of 2 bleach solutions observed; failed to ensure that patients are out of the dialysis chair before cleaning the dialysis station in 1 of 3 observations of staff discontinuing patient treatment (Patient (Pt) #14), in a total sample of 3 patients observed at the end of treatment. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last revised April 2023 revealed: - “Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood...” - “Cleaning of visible blood should be performed when first observed.” - “Dialysis station must be completely vacated by the previous patient before teammates can begin to bring disinfection supplies to the station, clean or disinfect the station...” - “Non-disposable items are to be disinfected after each use...Hemostats (blood line clamps) should be in open position and fully submerged in an appropriate disinfectant solution...” Review of policy and procedure #1-05-08B titled, “Preparation of One to One Hundred 1:100 Bleach Solution” last revised October 2023 revealed to, “...label container with expiration date, time, and initials. The solution is good for 24 hours...” On 07/22/2025 beginning at 9:25 AM observed Stations 3, 6, 8, 10 and 11 that were “clean” and set up for the next patient. Per observations, there was what appeared to be drops of blood on top of the lids of the biohazard containers at these stations. On 07/22/2025 beginning at 9:25 AM observed 1:100 bleach solution across from St #14 and 1:10 bleach solution across from St 19 that were not labeled with date, time, and staff initials as per policy. On 07/22/2025 beginning at 9:35 AM, observed Patient Care Technician (PCT) F cleaning and disinfecting dialysis station #12 after Pt #14’s treatment. When PCT F was asked if she had cleaned the machine already, PCT F stated that she cleaned the dialysis machine while Pt #14 was sitting in the chair holding his vascular access sites. PCT F stated that the she had to hurry up and clean the station because the next patient was coming in soon. On 07/22/2025 beginning at 9:40 AM, observed “dirty” hemostats in an empty bucket; the hemostats were not soaking in a disinfectant solution as per policy. Per interview with Facility Administrator (FA) A and FA B on 07/22/2025 beginning at 12:50 PM, FA A and FA B stated that the bleach solution should be labeled with staff initials, date, and time, the biohazard container should be cleaned and disinfected between patients, the patient should be discharged and out of the chair before staff begin disinfecting the station, and dirty hemostat clamps should be soaked in a bleach solution after use.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 29972 Based on record review and interview the facility failed to ensure that staff responsible for completing tasks in the water room received annual water room training and verify staff competency to perform their job duties in 5 of 5 personnel training files reviewed (Registered Nurse (RN) D, RN E, Patient Care Technician (PCT) G, PCT H, PCT I), in a total sample of 5 personnel files reviewed. Findings Include: Review of policy and procedure #1-15-01 titled, “...Dialysis Delivery System Cleaning and Disinfection Policy” last revised April 2019 revealed, “Only trained teammates will perform cleaning and disinfection of Fresenius dialysis delivery systems. Review of policy and procedure #1-20-01 titled, “Bicarbonate Concentrate System Mixing” last revised April 2024 revealed, “Only teammates who have been trained to operate the bicarbonate concentrate system mixer may complete the procedures used to rinse, clean, disinfect and prepare bicarbonate solution.” Review of the “CEC4012...Multi-Station Basic Components and Monitoring of Dialysis Quality Water Treatment Systems--Procedural Skills Verification Checklist for Teammates Who Perform Water Monitoring & Testing” form last revised April 2023 revealed, “After the teammate completes reading the listed Policies and Procedures and the StarLearning course and posttest the teammate will date and initial the line corresponding to the P&P (policy and procedure), StarLearning course and test and enter the test score as indicated.” Review of PCT G’s most recent “In-Center Annual Procedural Skills Verification Checklist” revealed PCT G was signed off as competent for the procedure of heat and chemical disinfection of the dialysis machines, proper start up after heat and chemical disinfection of the dialysis machines, and the proper performance of residual disinfectant testing on 05/15/2024; there was no documentation of PCT G completing this skills verification checklist within the last 12 months (should be annually). Review of PCT G’s most recent “Procedural Skills Verification Checklist for Teammates Who Perform Water Monitoring & Testing” revealed the skills verification was completed on 05/08/2024; there was no documentation of PCT G completing this skills verification checklist within the last 12 months. Review of PCT G’s StarLearning transcripts revealed there was no documentation of PCT G completing the required StarLearning for “CEC4012...Multi-Station Basic Components and Monitoring of Dialysis Quality Water Treatment Systems” within the last 12 months. Review on of PCT H’s most recent “In-Center Annual Procedural Skills Verification Checklist” revealed PCT H was signed off as competent for the procedure of heat and chemical disinfection of the dialysis machines, proper start up after heat and chemical disinfection of the dialysis machines, and the proper performance of residual disinfectant testing on 05/16/2024; there was no documentation of PCT H completing this skills verification checklist within the last 12 months. Review of PCT H’s most recent “Procedural Skills Verification Checklist for Teammates Who Perform Water Monitoring & Testing” revealed the skills verification was completed on 05/08/2024 and then again on 07/21/2025; there was no documentation of PCT H completing this skills verification checklist within the last 12 months. Review on of PCT I’s most recent “In-Center Annual Procedural Skills Verification Checklist” revealed PCT I was signed off as competent for the procedure of heat and chemical disinfection of the dialysis machines, proper start up after heat and chemical disinfection of the dialysis machines, and the proper performance of residual disinfectant testing on 05/16/2024; there was no documentation of PCT I completing this skills verification checklist within the last 12 months. Review of PCT I’s most recent “Procedural Skills Verification Checklist for Teammates Who Perform Water Monitoring & Testing” revealed the skills verification was completed on 05/08/2024. There was no documentation of PCT I completing the skills verification checklist within the last 12 months. Per interview with Facility Administrator (FA) A and FA B on 07/22/2025 beginning at 1:30 PM, FA A and FA B stated that they were unable to find documented evidence of RN D and RN E completing water room training and skills competencies within the last 12 months; FA B confirmed that RN D and RN E should have had this training completed. FA A and FA B stated that PCT I, PCT H, and PCT G are the only staff trained to disinfect the Bicarbonate loop; per FA B staff who perform this water room task should take a StarLearning online class called “Mixology” and should complete a “Bicarbonate Concentrate Procedural Skills Verification Checklist” annually; FA B stated that she was unable to find documented evidence of staff completing these requirements in the last 12 months. FA B stated that staff should have water room training completed within 3 months of hire and annually, including the StarLearning online class and skills competency verification. FA B stated that the facility is behind on the water room training and competencies and is working to catch up.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 29972 Based on record review, observations, and interview staff failed to maintain a sanitary environment free from potential infection control risk in 1 of 2 area observed (treatment area), in a total sample of 2 areas observed; failed to perform hand hygiene after removing gloves, between glove changes, and before touching “clean” equipment and/or obtaining clean supplies in 4 of 10 patient observations (Patient (Pt) #6, 13, 14, 15), in a total sample of 10 patients observed; failed to perform hand hygiene after removing gloves while cleaning and disinfecting the dialysis station in 1 of 3 observations of station cleaning (Station 3), in a total of 3 observations of station cleaning; failed to ensure patients perform hand hygiene after dialysis treatment using an Arteriovenous Fistula/Graft (AVF/G) in 1 of 2 patients observed with an AVF/G post treatment (Pt #1), in a total sample of 3 patients observed with an AVF/G; failed to change gloves when going from a “dirty” area to a “clean” area in 1 of 3 observations of staff performing conductivity testing (Patient Care Technician (PCT) J), in a total of 3 staff observed; failed to ensure that items brought into the dialysis station are cleaned and disinfected before returning to a common area in 3 of 10 patient observations (Patient (Pt) #1, 6, 16), in a total sample of 10 patients observed; and 1 of 3 staff observations of pH and conductivity testing (Patient Care Technician (PCT) J) in a total of 6 staff observed; failed to clean and disinfect all the equipment at the dialysis station between patients to prevent cross contamination in 2 of 3 observations of dialysis station cleaning (Station (St) #3, 5), in a total sample of 3 observations of station cleaning; failed to properly clean and disinfect computer carts within the dialysis station in 9 of 9 computer carts observed at the station (St #1, 3, 5, 6, 9, 17, 18, 19, 20), in a total sample of 9 computer carts observed; failed to clean and disinfect equipment used for independent pH and Conductivity testing in 1 of 2 staff observations of testing (Patient Care Technician (PCT) J); failed to ensure that “dirty” supplies are disinfected as per policy in 3 of 3 supplies observed (vascular access clamps, hemostats, wands), in total of 3 supplies observed; failed to ensure the bleach solution is labeled to ensure the appropriate concentration, effectiveness, and availability for use in 1 of 2 observations of bleach solution (1:100) in a total sample of 2 observations; failed to ensure staff are trained on how to mix bleach solution to ensure there is an appropriate concentration of bleach for effective disinfection in 2 of 2 staff interviews (Patient Care Technician (PCT) K and PCT L), in a total of 6 staff interviews; and failed to ensure Central Venous Catheters (CVCs) are accessed in a manner to prevent potential cross contamination in 3 of 4 patients observed with a CVC (Patient (Pt) #2, 3, 4) in a total sample of 4 patients observed with a CVC. Findings Include: Facility staff failed to maintain a sanitary environment free from potential infection control risk. See Tag V-0111. Facility staff failed to perform hand hygiene after removing gloves, between glove changes, and before touching “clean” equipment and/or obtaining clean supplies; failed to perform hand hygiene after removing gloves while cleaning and disinfecting the dialysis station; failed to ensure patients perform hand hygiene after dialysis treatment using an Arteriovenous Fistula/Graft (AVF/G); and failed to change gloves when going from a “dirty” area to a “clean” area in 1 of 3 observations of staff performing conductivity testing. See Tag V-0113. Facility staff failed to ensure that items brought into the dialysis station are cleaned and disinfected before returning to a common area. See Tag V-0116. Facility staff failed to clean and disinfect all the equipment at the dialysis station between patients to prevent cross contamination; failed to properly clean and disinfect computer carts within the dialysis station; failed to clean and disinfect equipment used for independent pH and Conductivity testing; failed to ensure that “dirty” supplies are disinfected as per policy; failed to ensure the bleach solution is labeled to ensure the appropriate concentration, effectiveness, and availability for use; and failed to ensure staff are trained on how to mix bleach solution to ensure there is an appropriate concentration of bleach for effective disinfection. See Tag V-0122. Facility staff failed to ensure Central Venous Catheters (CVCs) are accessed in a manner to prevent potential cross contamination. See Tag V-0147.”

“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: 29972 Based on record review, observations, and interview staff failed to maintain a sanitary environment free from potential infection control risk in 1 of 2 area observed (treatment area), in a total sample of 2 areas observed. Findings Include: Review of policy and procedure #8-04-01 titled, “Physical Environment” last revised 2018 revealed “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment.” Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last revised April 2023 revealed, “Clean areas should be clearly separated from contaminated areas...” Observations of the treatment area on 02/23/2024 revealed the following: -At 8:40 AM, observed 6 “dirty” cardboard shipping boxes (containing supplies) sitting directly on top of the “clean” counter tops, while Patient Care Technician (PCT) I and L unloaded the supplies. PCT I and L did not clean/disinfect the countertops after removing the boxes to reduce the potential for cross contamination. - At 9:00 AM, observed wall boxes at station (St) 1, 2, 3, 6, 8, 9, 11, 12, 14, 15, and 17 containing large amounts of white residue and white chunks of crystallized deposits on the surfaces of the wallbox and covering the acid and bicarbonate connector/ports. -At 9:20 AM, observed visible blood on top of the sharps container lid at St 11; the St was “clean” and supplies for the next patient (next day) were on the chair (still visible during observations at 2:15 PM). -At 1130 AM, observed a large puddle of water on the floor coming from the dialysis machine at St 10; a pile of wet paper towels and empty supply wrappers were on the floor in the water. Per observations the water spill and saturated paper towels were still present 2 hours later at 1:30 PM. -At 1:30 PM, observed large amount of white residue and white chunks of crystallized deposits on the floor under the counter at St 1, 2, 3, 4, 7, 8, 11, 12, and 13. During interview with Clinical Coordinator (CC) C, Manager of Clinical Services (MCC) E, and Facility Administrator (FA) A, while discussing observations on 02/23/2024 beginning at 2:15 PM; FA A, CC C, and MCC E observed and confirmed the findings for the wall boxes, the floor at the stations, and the visible blood on the lid of sharps container. When asked who is responsible for cleaning the floors in the treatment area, FA A stated the janitorial staff are responsible but it has been a difficult to get the janitorial staff to clean the floor behind the machines. Per interview, CC C stated that PCTs are responsible for cleaning the wall boxes at the station after every patient treatment. MCC E stated that staff should not be placing cardboard shipping boxes on “clean” countertops.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 29972 Based on record review, observation, and interview staff failed to perform hand hygiene after removing gloves, between glove changes, and before touching “clean” equipment and/or obtaining clean supplies in 4 of 10 patient observations (Patient (Pt) #6, 13, 14, 15), in a total sample of 10 patients observed; failed to perform hand hygiene after removing gloves while cleaning and disinfecting the dialysis station in 1 of 3 observations of station cleaning (Station 3), in a total of 3 observations of station cleaning; failed to ensure patients perform hand hygiene after dialysis treatment using an Arteriovenous Fistula/Graft (AVF/G) in 1 of 2 patients observed with an AVF/G post treatment (Pt #1), in a total sample of 3 patients observed with an AVF/G; and failed to change gloves when going from a “dirty” area to a “clean” area in 1 of 3 observations of staff performing conductivity testing (Patient Care Technician (PCT) J), in a total of 3 staff observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: -“All Teammates...will perform hand hygiene...b. prior to gloving and immediately after removal of gloves...d. after patient and dialysis delivery system contact...g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.” - “Patients and caregivers will be encouraged to...b. Perform hand hygiene after treatment before leaving treatment areas.” - “Disposable glove will be worn when caring for the patient or touching the patient’s equipment at the dialysis station...a. Gloves should be changed when: ...ii. When going from a “dirty” area or task to a “clean” area or task...iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system.” - “The chair side cart...monitor and keyboard are considered clean areas.” Findings Include: On 02/23/2024 observed the following: -At 08:30 AM, observed Patient Care Technician (PCT) J type on the computer keyboard while wearing gloves at station (St) 20 during Pt #13’s treatment; PCT J removed gloves, did not perform hand hygiene, than donned a new pair of gloves. PCT J proceeded to type on the computer keyboard at St 18 (during Pt 14’s treatment) and at St 16 (during Pt #15’s treatment) while wearing the same gloves. PCT J did not remove gloves and perform hand hygiene when using the computer keyboard and before moving from station to station. -At 8:47 AM, observed PCT J cleaning St 3; PCT J obtained “clean” wipes and saturated the wipes in the bleach solution (at the “clean” counter), while wearing the same gloves used to clean the “dirty” dialysis station. PCT J did not remove gloves, perform hand hygiene, and don a new pair of gloves before obtaining additional bleach wipes to prevent potential cross contamination. -At 9:42 AM, observed PCT J discontinuing Pt #1 dialysis treatment using a AVF/G. Observed Pt #1 holding gauze over AVF/G without wearing a glove. Pt #1 did not perform hand hygiene after holding vascular access site and before exiting the treatment area. -At 9:58 AM, observed PCT I performing independent conductivity and PH testing using a Myron meter. PCT I donned gloves then proceeded to pour a water sample from the dialysis machine into a plastic cup at the station. PCT I then proceeded to access the Myron meter at the “clean” counter to perform the testing without first removing the “dirty” gloves, performing hand hygiene, and donning a “clean” pair of gloves to prevent cross contamination of equipment. -At 1:30 PM, observed PCT I cannulate Pt #6’s AVF/G, then removed gloves and obtained clean supplies from the supply drawer; PCT I did not perform hand hygiene after removing gloves and before obtaining clean supplies. During interview with Clinical Coordinator (CC) C, Manager of Clinical Services (MCC) E, and Facility Administrator (FA) A, while discussing observations on 02/23/2024 beginning at 2:15 PM; CC C stated that staff should be performing hand hygiene between glove changes and after removing gloves. Per CC C, staff should remove “dirty” gloves and don a “clean” pair of gloves before obtaining additional bleach wipes. CC C stated that the computer carts/keyboard are considered “clean” equipment and staff should not wear gloves while typing on the keyboard. CC C stated that patient should wear a glove while holding vascular access site and staff should offer patients sanitizer after removing glove. CC C stated the Myron meter is stored on the “clean” counter.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 29972 Based on observation, record review, and interview staff failed to ensure that items brought into the dialysis station are cleaned and disinfected before returning to a common area in 3 of 10 patient observations (Patient (Pt) #1, 6, 16), in a total sample of 10 patients observed; and 1 of 3 staff observations of pH and conductivity testing (Patient Care Technician (PCT) J) in a total of 6 staff observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last revised April 2023 revealed, “Non disposable items are to be disinfected after each patient use, prior to removal from treatment area/station...” Observations on 02/23/2024 revealed the following: -At 9:42 AM observed Patient Care Technician (PCT) J discontinuing Pt #1’s dialysis treatment using a Arteriovenous Fistula/Graft (AVF/G). PCT brought a wheeled stool into the station to sit on while PCT J pulled out Pt #1’s needles. PCT J did not clean/disinfect the stool before returning to a common area, to prevent potential cross contamination. -At 11:20 AM observed PCT J performing independent pH and conductivity testing using a Myron Meter. PCT J donned gloves, then obtained the Myron Meter and bottle of pH test strips (from the “clean” counter) and placed the supplies/equipment on the dialysis chairs tray table at station 17. PCT J obtained a water sample from the dialysis machine and poured it directly in the Myron meter; PCT J then retrieved a test strip from the bottle and tested the water. PCT J proceeded to return the Myron Meter and the bottle of test strips to the “clean” counter, without cleaning/disinfecting before returning to a common/clean area. - At 1:15 PM observed PCT J discontinuing Pt #16’s dialysis treatment using an AVF/G. PCT J brought a wheeled stool into the station to sit on while PCT J pulled out Pt #16’s needles. PCT J did not clean/disinfect the stool before returning to a common area, to prevent potential cross contamination. -At 1:25 PM observed PCT I initiating Pt #6’s dialysis treatment using an AVF/G. PCT I brought a wheeled stool into the station to sit on while PCT I cannulated Pt #6’s AVF/G. PCT I did not clean/disinfect the stool before returning to a common area, to prevent potential cross contamination. During interview with Clinical Coordinator (CC) C, Manager of Clinical Services (MCC) E, and Facility Administrator (FA) A, while discussing observations on 02/23/2024 beginning at 2:15 PM; CC C stated that staff should be cleaning/disinfecting equipment (stool) if brought into the dialysis station and before returning to a common area. CC C stated that staff should not be taking the Myron Meter and bottle of test strips into the dialysis station, per CC C staff should retrieve the water sample from the machine and bring the sample to the counter to perform the pH and Conductivity testing.”

“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: 29972 Based on observation, record review, and interview staff failed to clean and disinfect all the equipment at the dialysis station between patients to prevent cross contamination in 2 of 3 observations of dialysis station cleaning (Station (St) #3, 5), in a total sample of 3 observations of station cleaning; failed to properly clean and disinfect computer carts within the dialysis station in 9 of 9 computer carts observed at the station (St #1, 3, 5, 6, 9, 17, 18, 19, 20), in a total sample of 9 computer carts observed; failed to clean and disinfect equipment used for independent pH and Conductivity testing in 1 of 2 staff observations of testing (Patient Care Technician (PCT) J); failed to ensure that “dirty” supplies are disinfected as per policy in 3 of 3 supplies observed (vascular access clamps, hemostats, wands), in total of 3 supplies observed; failed to ensure the bleach solution is labeled to ensure the appropriate concentration, effectiveness, and availability for use in 1 of 2 observations of bleach solution (1:100) in a total sample of 2 observations; and failed to ensure staff are trained on how to mix bleach solution to ensure there is an appropriate concentration of bleach for effective disinfection in 2 of 2 staff interviews (Patient Care Technician (PCT) K and PCT L), in a total of 6 staff interviews. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: -“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 and sides of dialysis machine; touchscreens; countertops)...the Wall box, drain, and water supply lines are considered part of the dialysis delivery system.” - “The chair side cart...monitor and keyboard are considered clean areas...b. the chair side cart components will be cleaned at the end of each treatment day.” - “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.” - “Hemostats (blood line clamps) should be in the open position and fully submerged in an appropriate disinfectant solution...Containers used to soak clamps, or other non-disposable equipment will be cleaned and disinfected at the conclusion of the day, or immediately after visible contamination.” Review of policy and procedure #2-08-01B titled, “Operation of Portable Myron L Conductivity Meter D-1” last revised October 2018 revealed, “The exterior of D1 meter should be cleaned with 1:100 bleach solution after collecting a sample from another dialysis delivery system to prevent cross contamination.” Review of policy and procedure #1-05-08 titled, “Bleach Policy” last revised October 2023 revealed the following: - “A one to ten (1:10) bleach solution is used to clean and decontaminate any environmental surface or non-disposable supplies which are visibly contaminated with blood or body fluids.” - “A 1:100 bleach solution is used for routine disinfection procedures of environmental surfaces or non-disposable supplies which are not visibly contaminated with blood or bodily fluids.” - “Bleach solution needs to be covered with a secure lid...NOTE: without a secure lid, the bleach solution is open to air causing the solution to degrade over time and become less effective.” Review of policy and procedure #1-05-08B titled, “Preparation of one to one hundred (1:100) Bleach Solution” last revised October 2023 revealed the following: - “...Mixing 1 part bleach with 99 parts water = 1:100 bleach solution...Calculations: 1000 ml (milliters) = 10 ml bleach + 990 ml water.” - “...label container with expiration date, time and initials. The solution is good for 24 hours only.” Review of policy and procedure #1-05-08A titled, “Preparation of one to ten (1:10) Bleach Solution” last revised October 2023 revealed the following: - “...Mixing 1 part bleach with 9 parts water = 1:10 bleach solution...Calculations: 1000 ml = 100 ml bleach + 900 ml water.” - “...label container with expiration date, time and initials. The solution is good for 24 hours only.” Station Cleaning: On 02/23/2024 at 8:54 AM, observed PCT J cleaning and disinfecting St 3. PCT J did not clean the following: -Basket attached to the dialysis machine -Hoses and lines attached to the dialysis machine -Sharps container -Outside of Garbage can -Crevices between the arm rest and tray table (fold down the tray table) -Counter tops at the station -Wallbox including acid and bicarbonate ports/connectors On 02/23/2024 at 9:05 AM, observed PCT L cleaning and disinfecting St 5. PCT L did not clean the following: -Basket attached to the dialysis machine -Hoses and lines attached to the dialysis machine -Outside of Sharps container -Outside of garbage can -Wallbox including acid and bicarbonate ports/connectors -Counter top at the station On 02/23/2024 at 11:15 AM, while observing PCT I cleaning the dialysis machine at St 13, PCT I pulled the acid hose connector from the wall box and the hose fell onto the floor. PCT I then picked up the hose and inserted the connector into the dialysis machine without cleaning and disinfecting the acid connector. Computer carts: Per observations on 02/23/2024 at 8:30 AM, the computer carts at St 1, 3, 5, 6, 9, 17, 18, 19, and 20 were within the patient stations within 2 to 3 inches from the dialysis machine and/or dialysis chair and sharps container during patient treatments, allowing for potential cross contamination. Per interview with Clinical Coordinator (CC) C on 02/23/2024 beginning at 2:15 PM, CC C stated that the computer carts are considered “clean” and are not considered part of the patient station. Per CC C the computer carts are cleaned at the end of the treatment day, and not between patients. Equipment/Supplies: On 02/23/2024 at 8:40 AM, observed “dirty” vascular access clamps and hemostats (blood line clamps) soaking in a container filled with a bleach solution that was visibly soiled with reddish brown debris; per policy the bleach solution should be changed immediately after visible contamination. The bleach solution was not labeled with the concentration, date made, and initials of staff as per policy. Per observations the bleach solution was not covered with a lid as per policy. Per interview with Registered Nurse (RN) G at the time of the observation, RN G confirmed the clamps and hemostats were in a bleach solution and stated the bleach solution should be labeled as per policy. On 02/23/2024 at 8:45 AM observed vascular access clamps, hemostats, and wands in a container labeled “dirty...1:100 bleach solution”; there was no bleach solution observed in the container. Per interview with PCT K at the time of the observations, PCT K confirmed there was no bleach solution made and stated that the “dirty” clamps, hemostats, and wands should be soaking in a bleach solution. On 02/23/2024 beginning at 11:20 AM, observed PCT I performing conductivity and pH testing. PCT I donned gloves then proceeded to obtain a water sample from the dialysis machine and pour into a cup. PCT I then poured the water sample into the Myron meter located on the “clean” counter top to perform the conductivity test. PCT I then obtained a pH testing strip from the testing strip bottle to check the pH. PCT I did not clean and disinfect the test strip bottle and the Myron Meter after use to prevent potential cross contamination. Bleach mixing and availability: Per observations on 02/23/2024 beginning at 8:15 AM to 11:30 AM, there was no 1:10 bleach solution made to ensure supplies and equipment with visible blood contamination could be disinfected effectively as per policy. Per interview with PCT K on 02/23/2024 at 8:21 AM, when asked how PCT K makes 1:100 and 1:10 bleach solution, PCT K stated she was not aware of how much bleach and water should be used to make each concentration. PCT K stated that she usually just “eyes” it. Per PCT K, the PCT assigned to the POD is responsible for making the bleach solution for that POD. Per interview with PCT L on 02/23/2024 at 9:05 AM, when asked how PCT L makes 1:10 bleach solution, PCT L stated that she/he adds 100 ml part bleach to 3900 ml part water; this was inconsistent with the policy (should be 390 ml).”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 29972 Based on record review, observation and interview staff failed to ensure Central Venous Catheters (CVCs) are accessed in a manner to prevent potential cross contamination in 3 of 4 patients observed with a CVC (Patient (Pt) #2, 3, 4) in a total sample of 4 patients observed with a CVC. Findings include: Review of policy and procedures #1-04-02B titled, “Central Venous Catheter....” last reviewed October 2023 revealed the following: - “Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason.” - “2% Chlorhexidine Gluconate/70% Isopropyl Alcohol...Effective for CVC access exit site...Effective Contact Time 30 seconds back and forth motion...” Review of the CVC procedure “Upon completion of dialysis” revealed to, “...Aseptically disconnect arterial blood line from arterial CVC limb. Attach a 10 milliter (ml) syringe filled with normal saline to arterial catheter limb and push normal saline into arterial port...” Per review, the procedure in the policy did not include to perform a 15 second hub scrub after disconnecting the blood lines and before attaching normal saline syringe, to ensure potential contaminates are not pushed into the blood stream. Review of CDC (Centers for Disease Control) “Hemodialysis Central Venous Catheter Scrub the Hub Protocol” last reviewed September 26, 2016 revealed, “Catheter hubs should be disinfected again after disconnecting from bloodlines and before replacing a new cap at the end of a treatment. This should be done in a manner similar to that used when disinfecting the hub prior to accessing. On 02/23/2024 beginning at 11:02 AM, observed Patient Care Technician (PCT) H initiating Pt #2’s dialysis treatment using a CVC. PCT H scrubbed the CVC exit site with Chlorhexidine/Isopropyl Alcohol for 20 seconds, not 30 seconds as per policy. PCT H scrubbed the CVC hubs with alcohol wipe for 11 seconds (hub #1) and 5 seconds (hub #2), not 15 seconds per hub as per policy. On 02/23/2024 beginning at 11:10 AM, observed PCT J initiating Pt #3’s dialysis treatment using a CVC. PCT J scrubbed both CVC hubs with alcohol wipe for 6 seconds, not 15 seconds per hub as per policy. On 02/23/2024 beginning at 11:15 AM, observed Registered Nurse (RN) F discontinuing Pt #4’s treatment using a CVC. RN F did not scrub the CVC ports after disconnecting the blood lines and prior to connecting the 10 ml syringe as per the CDC Scrub the Hub Protocol. During interview with Clinical Coordinator (CC) C, Manager of Clinical Services (MCC) E, and Facility Administrator (FA) A, while discussing observations on 02/23/2024 beginning at 2:15 PM; CC C stated that staff should scrub each CVC hub for 15 seconds and CVC exit site for 30 seconds as per policy. MCC E confirmed that the staff follow the policy and the policy should follow CDC guidelines.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 29972 Based on observation, record review, and interview staff failed to document machine conductivity using an independent method prior to each dialysis treatment in 2 of 5 medical records reviewed (Patient (Pt) #5, 8); and failed to properly calibrate the equipment used for independent machine conductivity testing as per policy and to properly check the machine pH as per policy in 2 of 3 staff observations (Patient Care Technician (PCT) L, PCT H, PCT I), in a total sample of 3 staff observed. Findings Include: Review of policy and procedure #1-03-02 titled, “Testing pH and Conductivity of Proportioned Dialysate...” last revised April 2020 revealed the following: - “Trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and or meters prior to each patient treatment.” - “Document results in the electronic treatment record...” - “If independent results are not within acceptable range, recalibrate meter and retest. If result are still outside acceptable range, do not use the delivery system for patient treatment...” Review of policy and procedure #12-13-10E titled, “Calibration Check and Calibration of Portable Myron L Conductivity Meter (D-1)” last revised October 2022 revealed the following: - “To recalibrate the meter, remove the bottom cover using fingernails or a small screwdriver to loosen the front or rear edge. Identify the Calibration Control so it can be found by touching while calibrating...Test another sample of the standard solution...Adjust the Calibration Control until the meter point indicates the standard solution reference value.” Review of the procedure “Testing pH of Proportioned Dialysate for Conventional Dialysis Delivery System using RPC pH 0-14 Test Strips” no date revealed the following: - “Insert multicolored portion of the test strip into the water sample until the color on the strip no longer changes...Wait 10 seconds before reading the pH result...Compare the color on the strip to the color on the chart located on the test strip bottle to determine the match.” Observations: On 02/23/2024 beginning at 9:45 AM, observed PCT L attempting to calibrate the Myron meter. PCT L kept pouring the standard solution into the meter and dumping it out; PCT L stated the meter was not working. Per observations, PCT L did not adjust the Calibration Control and calibrate the meter as per policy (PCT L obtained a different Myron meter to perform conductivity testing). Observed PCT L performing the pH testing, PCT L placed the strip in the water sample and stirred for 6 seconds, then compared the strip to the bottle right away; PCT L did not wait 10 seconds as per policy. On 02/23/2024 beginning at 10:00 AM, observed PCT I performing pH and conductivity testing. PCT I dipped the pH test strip in the water sample for 10 seconds, then compared the strip to the bottle right away; PCT L did not wait 10 seconds as per policy. When asked how to calibrate the Myron meter, PCT I stated that she/he pours the 14.0 standard solution in the meter than dumps it. PCT I did not address adjusting the Calibration Control to calibrate the meter. On 02/23/2024 beginning at 11:00 AM, observed PCT H performing pH and conductivity testing. PCT H dipped the test strip in the water sample then compared the test strip to the bottle right away, PCT H did not wait 10 seconds as per policy. When asked how to calibrate the Myron meter, PCT H stated that she/he did not know how to calibrate the meter; Per PCT H, she/he was shown once but cannot remember. Per interview with PCT L on 02/23/2024 at 9:50 AM, PCT L stated that the opening PCT is responsible for the daily calibration of all the Myron meters in the morning. Per interview with Registered Nurse (RN) G on 02/23/2024 at 9:55 AM, RN G stated that each PCT is responsible for the daily calibration of the Myron meter at their assigned POD. Per interview with PCT K on 02/23/2024 at 10:10 AM, PCT K stated that the opening PCT is responsible for the daily calibration of the Myron meter. PCT K stated that there has been times when she/he came in and the Myron meter calibration was not done, so PCT K stated that she/he had to do it. Medical Record Review: Review of Pt #5’s dialysis treatment sheet dated 02/20/2024, revealed there was no documentation of an independent conductivity check completed prior to treatment. Review of Pt #8’s dialysis treatment sheet dated 02/19/2024, revealed there was no documentation of an independent conductivity check completed prior to treatment. Per interview with Clinical Coordinator (CC) C on 02/23/2024 at 10:30 AM, CC C stated that there has been some “confusion” among PCTs as to who is responsible for the daily Myron meter calibration. Per CC C she/he assumed the PCT in POD 4 was responsible for the daily calibration. Per CC C, staff should be checking conductivity using a Myron meter before every treatment and documenting this in the medical record. Per CC C, all staff were re-educated on conductivity and pH testing in February 2024 due to concerns identified with staff testing pH and conductivity; Per CC C, staff have not conducted audits/monitoring to ensure conductivity/pH testing is performed correctly.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 29972 Based on observation, record review, and interview staff failed to ensure that all patient’s faces are visible during dialysis treatment in 1 of 20 patients observed (Patient (Pt) #3), in a total sample of 20 patients observed. Findings Include: Review of the policy and procedure #8-04-01 titled, “Physical Environment” last revised April 2018 revealed, “Teammates will be able to visualize patients at all times during hemodialysis treatments for patient safety.” On 02/23/2024 at 8:30 AM, observed Pt #3 at station #9 receiving dialysis treatment with a hood covering Pt #3’s face. Observed Patient Care Technician (PCT) L lift up Pt #3’s hood and then placed the hood back over Pt #3’s face and walk away. During interview with PCT L on 02/23/2024 beginning at 10:00 AM, PCT L stated that patient’s should not have their face covered during dialysis treatment.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 29972 Based on record review and interview staff failed to recognize and address shortened treatments as per policy in 4 of 10 medical records reviewed (Patients #5, 9, 10, 17), in a total sample of 10 medical records reviewed. Findings Include: Review of policy and procedure #1-01-09 titled, “Prescribed Treatment Time Not Met” last revised October 2023 revealed the following: - “The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time.” - “If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist (Kidney Physician) to discuss the appropriate intervention including what additional medical orders may be necessary to address the patient’s specific needs.” - “...If a patient’s treatment is shortened/early terminated, the RN will document the event in the patient’s electronic health record. Documentation will include, as appropriate: The amount of time by which the treatment was shortened...A description of why the treatment was shortened...Whether the patient’s nephrologist was notified...A description of all other interventions planned to address the shortened treatment, including recommendation to the patient.” Reviewed Pt #5’s dialysis treatment sheets dated 02/16/2024 revealed Pt #5’s ordered dialysis treatment time is 3 hours and 30 minutes. Per review of the treatment sheet, Pt #5 dialyzed for 2 hours and 51 minutes (39 minutes short). There was no documentation addressing why Pt #5 did not receive his/her prescribed treatment time and nursing interventions as per policy. Reviewed Pt #9’s dialysis treatment sheets dated 02/19/2024 revealed Pt #9’s ordered dialysis treatment time is 3 hours and 30 minutes. Per review of the treatment sheet, Pt #9 dialyzed for 3 hours and 15 minutes (15 minutes short). There was no documentation addressing why Pt #9 did not receive his/her prescribed treatment time and nursing interventions as per policy. Reviewed Pt #10’s dialysis treatment sheets dated 02/22/2024 revealed Pt #10’s ordered dialysis treatment time is 3 hours and 30 minutes. Per review of the treatment sheet, Pt #10 dialyzed for 3 hours and 13 minutes (17 minutes short). There was no documentation addressing why Pt #10 did not receive his/her prescribed treatment time and nursing interventions as per policy. Reviewed Pt #17’s dialysis treatment sheets dated 02/17/2024 revealed Pt #17’s ordered dialysis treatment time is 4 hours. Per review of the treatment sheet, Pt #17 dialyzed for 3 hours and 23 minutes (37 minutes short). There was no documentation addressing why Pt #17 did not receive his/her prescribed treatment time and nursing interventions as per policy. During interview with Clinical Coordinator (CC) C, Manager of Clinical Services (MCC) E, and Facility Administrator (FA) A, while discussing medical record findings on 02/23/2024 at 4:30 PM, CC C confirmed findings and stated staff should be documenting in the medical record the reason patient’s time was shortened, and nursing interventions addressing shortened treatment. CC C confirmed there was no documentation of Early Termination of Treatment Against Medical Advice forms signed for the above findings.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 29972 Based on record review, observation, and interview staff failed to handle the Arteriovenous Fistula/Graft (AVF/G) aseptically to prevent potential cross contamination in 1 of 2 observations of initiation of dialysis using an AVF/G (Patient (Pt) #16); and failed to appropriately assess the AVF/G prior to cannulation in 1 of 2 observations of initiation of dialysis using an AVF/G (Pt #6); in a total sample of 4 patients observed with an AVF/G. Findings Include: Review of policy and procedure #1-04-01 titled, “Arteriovenous Fistula (AVF) and Arteriovenous Graft (AVG) Vascular Access Care...” last reviewed October 2023 revealed the following: - “Inspection of the AVF or AVG access includes the following:...Presence/absence of thrill and/or bruit...” On 02/23/2024 at 1:15 PM observed Patient Care Technician (PCT) J discontinuing Pt #16’s dialysis treatment using an AVF/G. PCT J stuck a strip of tape on the front of the dialysis machine; PCT J then applied the same tape to Pt #16’s skin over the AVF/G to secure the gauze, allowing for potential cross contamination. On 02/23/2024 at 1:25 PM observed PCT I initiating Pt #6’s dialysis treatment using an AVF/G. PCT I did not check for the bruit (sound of blood flow heard through a stethoscope) prior to cannulating Pt #6’s AVF/G to ensure the access site was functioning properly. During interview with Clinical Coordinator (CC) C, Manager of Clinical Services (MCC) E, and Facility Administrator (FA) A, while discussing observations on 02/23/2024 beginning at 2:15 PM; CC C stated that staff should check for the bruit and thrill prior to cannulation of an AVF/G. CC C stated that staff should not stick the tape (used to secure the gauze onto skin) on the dialysis machine prior to taping up the AVF/G site, the tape should be removed from the roll at point of use, or the tape strips should be placed on a clean pad.”