Davita Warren Dialysis

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 44820 Based on review of facility policy, observation, and interviews conducted with staff and the Facility Administrator the agency failed to ensure designated “clean” areas maintained separation from “dirty”/used equipment and failed to follow policy and procedure for medication preparation when preparing filled syringes for 4 (four) of 4 (four) observations (OBS). Findings included: A review of facility policy on 11-18-25 at approximately 11:30am revealed: “Procedure: 1-05-01... Title: Infection Control for Dialysis Facilities... Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment... POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients... PPE (i.e., gown, gloves, eye protection, face shield)... 16. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled...” Review of CDC website; https://www.cdc.gov/infection-control/media/pdfs/Outpatient-Guide-508.pdf revealed: “Key recommendations for use of PPE in outpatient settings:... 4. Wear a gown to protect skin and clothing during procedures or activities where contact with blood or body fluids is anticipated... a. Do not wear the same gown for the care of more than one patient...” Review of CDC website; https://www.cdc.gov/dialysis-safety/media/pdfs/Hemodialysis-InjectionSafety-Checklist-P.pdf “Checklist: Hemodialysis injectable medication preparation... Prepare injectable medications in a designated clean workspace that is free of obvious contamination sources (e.g., blood, body fluids, contaminated equipment, tap water). This workspace should be clearly separated from the patient treatment area, and ideally in a separate room...” A review fo facility policy on 11-20-25 at approximately 10:00am revealed: “Procedure: 1-06-01A... Title: Preparation and Administration of Parenteral Medications (NON-ESA, NON-PARSABIV)... Procedure:...1. Perform hand hygiene. Put on PPE... 3... If the medication preparation area is located in the treatment area, a gown or lab coat is to be worn at all times... 16. Label the syringe with the patient’s name, name of the prescribed medication, dose, date, time and initials of licensed teammate preparing the dose... 17. Distribute the medication to the patient station in an aseptic manner. For example, place patient syringe(s) in a recloseable plastic bag if medication is not administered immediately...” OBS#1: 11-17-25 at approximately 10:00am charge nurse (EMP) observed engaging with patients, performing nursing assessments at chairside and engaging in direct patient contact. Approximately 10:15am surveyor requested tour of facility while awaiting arrival of facility administrator. EMP began escorting state surveyor through the facility. Tour began directly from patient treatment area to water treatment room then to clean supply room. EMP did not remove “used” PPE while entering designated “clean” areas. While in supply room surveyor requested a clean gown to don prior to touring the active patient treatment area and EMP states “Oops, I guess I should’ve taken this gown off before taking the tour.” OBS#2: 11-17-25 at approximately 10:30am patient personal wheelchairs, belongings, bags and pillows were observed stored in “clean” area that housed “clean” IV medication pumps for direct patient use, office/facility holiday decorations and “clean” blankets for direct patient use. OBS#3: 11-17-25 at approximately 10:45am; 6 (six) syringes, filled with medication ready to administer to patients, contained medication labels that did not have licensed staff initial of preparer and did not contain time that medications were prepared. OBS#4: The staff nurse was observed by surveyor on 11-17-25 at approximately 11:30 am performing patient assessment activities, which requires direct physical contact with the patients, for approximately three separate patients. Immediately following patient contact, gloves were removed, hand hygiene performed and staff nurse immediately entered “clean” designated medication preparation area without removing “used” gown/PPE after direct patient contact. Medication preparation for administration to a hemodialysis patient while wearing “used” gown/PPE was performed by nursing staff without donning a “clean” gown/PPE. An interview conducted with the Facility Administrator on 11-21-25 at approximately 1:00 PM confirmed the above findings. Facility Administrator states “None of our facilities have ever been told that PPE/gown could not be worn from treatment area while preparing medications. Our nurses wash their hands and change gloves for med prep.””

“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: 44820 Based on review of facility policy and procedure and observation and staff interviews, the facility failed to ensure that staff prepared and labeled bleach solutions for three (3) of three (3) observations (OBS). Findings: Review of facility policy and procedure on 11-17-25 at approximately 2:00pm, “Policy: 1-05-08... Title: Bleach Policy... Purpose: To provide guidance for preparation of bleach solutions for cleaning purposes... Policy:... 3. A 1:10 (one to ten) bleach solutions is used to clean and decontaminate any environmental surfaces or non-disposable supplies which are visibly contaminated with blood or body fluids... 4. A 1:100 (one to one hundred) 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... 5. Bleach solution needs to be covered witha secure lid and the solution should not be placed in the splash zone. 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 facility policy and procedure on 11-17-25 at approximately 2:15pm, “Procedure: 1-05-08A... Title: Preparation of one to ten (1:10) bleach solution... materials required:... container with lid... label with one to ten (1:10) bleach solution and permanent HazCom label... Procedure:... 5. Remove previously applied mixing label, including expiration date, time and initials, but do not remove HazCom label... New mixing label will be applied at the completion of this procedure. Verify HazCom and chemical identification labels are still intact and legible... 12. With indelible marking pen and label, label container with expiration date, time and initiasl. The solution is good for 24 hours only. The solution must be changed when the maximum allowable time is exceeded (24 hours) ... 13. When the solution is not being used, place a lid on the bleach solution container. Bleach solutions opern to aire causes the solution to degrade over time and becomes less effective.” Review of facility policy and procedure on 11-17-25, at approximately 2:30pm, “Procedure: 1-05-08B... Title: Preparation of one to one hundred (1:100) bleach solution... Materials required... container with lid... label with one to one hundred (1:100) bleach solution and permanent HazCom label... Procedure:... 5. Remove previously applied mixing label, including expiration date, time and initials, but do not remove HazCom label... New mixing label will be applied at the completion of this procedure. Verify HazCom and chemical identification labels are still intact and legible... 12. With indelible marking pen and label, label container with expiration date, time and initiasl. The solution is good for 24 hours only. The solution must be changed when the maximum allowable time is exceeded (24 hours) ... 13. When the solution is not being used, place a lid on the bleach solution container. Bleach solutions opern to aire causes the solution to degrade over time and becomes less effective.” OBS#1: 11-17-25 at approximately 10:50am revealed: Three prepared solutions, in open rectangular containers, without a sealed lids, container #1 stored by “clean” sink #1 labeled 1:10 bleach solution; container #2 stored by dirty sink #1 with visible hemostats and fistula clamps in the container labeled as: 1:100 bleach solution; container #3 placed by “clean” sink #1 with soaking “rags” visible labeled 1:100 bleach solution were dated 11-3-25/11-4-25 no time noted. As dated all aformentioned solutions were “expired” related to being labeled greater than 24 hours old and not being sealed properly to retain effectiveness. OBS#2: 11-17-25 at approximately 10:55am revealed: Three prepared solutions, in open rectangular containers, without a sealed lids, container #1 stored by “clean” sink #2 labeled 1:10 bleach solution; container #2 stored by dirty sink #2 with visible hemostats and fistula clamps in the container labeled as: 1:100 bleach solution; container #3 placed by “clean” sink #2 with soaking “rags” visible labeled 1:100 bleach solution were dated 11-3-25/11-4-25 no time noted. As dated all aformentioned solutions were “expired” related to being labeled greater than 24 hours old and not being sealed properly to retain effectiveness. OBS#3: 11-17-25 at approximately 11:00 am revealed: Four “squirt” bottles observed contained a clear liquid did not contain any labels regarding contents of the bottles and did not contain HazCom labels on the bottles. Charge nurse states “the “squirt bottles” contain 1:100 bleach solution.” and confirmed none of the containers were labeled at all. 11-17-25 Interview with charge nurse at approximately 11:00 am confirmed all above aformentioned “squirt bottles” of bleach solutions were not labeled with contents, did not have HazCom label applied and all bleach solutions that were utilized for disinfection of surfaces and supplies contained date of 11-3-25/11-4-25 without a time notation; which is greater than 24 hours old. OBS#4 11-21-25 at approximately 2:00 pm revealed: Four “squirt” bottles observed contained 1:100 bleach solution and did not contain hazardous labels on the bottles. Facility administrator interviewed during observation confirmed all above mentioned “squirt bottles” of bleach solutions were not labeled with contents and were not labeled for hazardous spills. 11-21-25 Interview with clinic manager/facility administrator after observations confirmed above findings.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 44820 Based on review of facility policy, observation, and interviews conducted with staff and the Facility medical director failed to ensure all staff adhered to policy and procedure for 8 (eight) of 8 (eight) observations (OBS). Findings included: Review of facility policy and procedure on 11-17-25 at approximately 2:00pm, “Policy: 1-05-08... Title: Bleach Policy... Purpose: To provide guidance for preparation of bleach solutions for cleaning purposes... Policy:... 3. A 1:10 (one to ten) bleach solutions is used to clean and decontaminate any environmental surfaces or non-disposable supplies which are visibly contaminated with blood or body fluids... 4. A 1:100 (one to one hundred) 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... 5. Bleach solution needs to be covered witha secure lid and the solution should not be placed in the splash zone. 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 facility policy and procedure on 11-17-25 at approximately 2:15pm, “Procedure: 1-05-08A... Title: Preparation of one to ten (1:10) bleach solution... materials required:... container with lid... label with one to ten (1:10) bleach solution and permanent HazCom label... Procedure:... 5. Remove previously applied mixing label, including expiration date, time and initials, but do not remove HazCom label... New mixing label will be applied at the completion of this procedure. Verify HazCom and chemical identification labels are still intact and legible... 12. With indelible marking pen and label, label container with expiration date, time and initiasl. The solution is good for 24 hours only. The solution must be changed when the maximum allowable time is exceeded (24 hours) ... 13. When the solution is not being used, place a lid on the bleach solution container. Bleach solutions opern to aire causes the solution to degrade over time and becomes less effective.” Review of facility policy and procedure on 11-17-25, at approximately 2:30pm, “Procedure: 1-05-08B... Title: Preparation of one to one hundred (1:100) bleach solution... Materials required... container with lid... label with one to one hundred (1:100) bleach solution and permanent HazCom label... Procedure:... 5. Remove previously applied mixing label, including expiration date, time and initials, but do not remove HazCom label... New mixing label will be applied at the completion of this procedure. Verify HazCom and chemical identification labels are still intact and legible... 12. With indelible marking pen and label, label container with expiration date, time and initiasl. The solution is good for 24 hours only. The solution must be changed when the maximum allowable time is exceeded (24 hours) ... 13. When the solution is not being used, place a lid on the bleach solution container. Bleach solutions opern to aire causes the solution to degrade over time and becomes less effective.” A review of facility policy on 11-18-25 at approximately 11:30am revealed: “Procedure: 1-05-01... Title: Infection Control for Dialysis Facilities... Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment... POLICY: The Centers for Disease Control (CDC) Recommendations for Preventing Transmission of Infections among Chronic Hemodialysis Patients (Dialysis Precautions) will be followed when caring for all patients... PPE (i.e., gown, gloves, eye protection, face shield)... 16. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled...” Review of CDC website; https://www.cdc.gov/infection-control/media/pdfs/Outpatient-Guide-508.pdf revealed: “Key recommendations for use of PPE in outpatient settings:... 4. Wear a gown to protect skin and clothing during procedures or activities where contact with blood or body fluids is anticipated... a. Do not wear the same gown for the care of more than one patient...” Review of CDC website; https://www.cdc.gov/dialysis-safety/media/pdfs/Hemodialysis-InjectionSafety-Checklist-P.pdf “Checklist: Hemodialysis injectable medication preparation... Prepare injectable medications in a designated clean workspace that is free of obvious contamination sources (e.g., blood, body fluids, contaminated equipment, tap water). This workspace should be clearly separated from the patient treatment area, and ideally in a separate room...” A review fo facility policy on 11-20-25 at approximately 10:00am revealed: “Procedure: 1-06-01A... Title: Preparation and Administration of Parenteral Medications (NON-ESA, NON-PARSABIV)... Procedure:...1. Perform hand hygiene. Put on PPE... 3... If the medication preparation area is located in the treatment area, a gown or lab coat is to be worn at all times... 16. Label the syringe with the patient’s name, name of the prescribed medication, dose, date, time and initials of licensed teammate preparing the dose... 17. Distribute the medication to the patient station in an aseptic manner. For example, place patient syringe(s) in a recloseable plastic bag if medication is not administered immediately...” OBS#1: 11-17-25 at approximately 10:00am charge nurse (EMP) observed engaging with patients, performing nursing assessments at chairside and engaging in direct patient contact. Approximately 10:15am surveyor requested tour of facility while awaiting arrival of facility administrator. EMP began escorting state surveyor through the facility. Tour began directly from patient treatment area to water treatment room then to clean supply room. EMP did not remove “used” PPE while entering designated “clean” areas. While in supply room surveyor requested a clean gown to don prior to touring the active patient treatment area and EMP states “Oops, I guess I should’ve taken this gown off before taking the tour.” OBS#2: 11-17-25 at approximately 10:30am patient personal wheelchairs, belongings, bags and pillows were observed stored in “clean” area that housed “clean” IV medication pumps for direct patient use, office/facility holiday decorations and “clean” blankets for direct patient use. OBS#3: 11-17-25 at approximately 10:45am; 6 (six) syringes, filled with medication ready to administer to patients, contained medication labels that did not have licensed staff initial of preparer and did not contain time that medications were prepared. OBS#4: 11-17-25 at approximately 10:50am revealed: Three prepared solutions, in open rectangular containers, without a sealed lids, container #1 stored by “clean” sink #1 labeled 1:10 bleach solution; container #2 stored by dirty sink #1 with visible hemostats and fistula clamps in the container labeled as: 1:100 bleach solution; container #3 placed by “clean” sink #1 with soaking “rags” visible labeled 1:100 bleach solution were dated 11-3-25/11-4-25 no time noted. As dated all aformentioned solutions were “expired” related to being labeled greater than 24 hours old and not being sealed properly to retain effectiveness. OBS#5: 11-17-25 at approximately 10:55am revealed: Three prepared solutions, in open rectangular containers, without a sealed lids, container #1 stored by “clean” sink #2 labeled 1:10 bleach solution; container #2 stored by dirty sink #2 with visible hemostats and fistula clamps in the container labeled as: 1:100 bleach solution; container #3 placed by “clean” sink #2 with soaking “rags” visible labeled 1:100 bleach solution were dated 11-3-25/11-4-25 no time noted. As dated all aformentioned solutions were “expired” related to being labeled greater than 24 hours old and not being sealed properly to retain effectiveness. OBS#6: 11-17-25 at approximately 11:00 am revealed: Four “squirt” bottles observed contained a clear liquid did not contain any labels regarding contents of the bottles and did not contain HazCom labels on the bottles. Charge nurse states “the “squirt bottles” contain 1:100 bleach solution.” and confirmed none of the containers were labeled at all. OBS#7: The staff nurse was observed by surveyor on 11-17-25 at approximately 11:30 am performing patient assessment activities, which requires direct physical contact with the patients, for approximately three separate patients. Immediately following patient contact, gloves were removed, hand hygiene performed and staff nurse immediately entered “clean” designated medication preparation area without removing “used” gown/PPE after direct patient contact. Medication preparation for administration to a hemodialysis patient while wearing “used” gown/PPE was performed by nursing staff without donning a “clean” gown/PPE. OBS#8 11-21-25 at approximately 2:00 pm revealed: Four “squirt” bottles observed contained 1:100 bleach solution and did not contain hazardous labels on the bottles. Facility administrator interviewed during observation confirmed all above mentioned “squirt bottles” of bleach solutions were not labeled with contents and were not labeled for hazardous spills. 11-21-25 Interview with clinic manager/facility administrator after observations confirmed above findings.”