Jacksonville Dialysis Center

“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: 48653 Based on observation, record review, and interview, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis center’s In-Center Treatment Area. The facility staff failed to follow the facility policy, “General Cleanliness and Infection Control Guidelines”. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. Findings include: During a tour of the facility’s In-Center Treatment Area on 01/07/2025 at 11:00 AM the following infection control issues were identified: *The “clean sink” located along the back wall of the in-center treatment area was corroded in areas. There was a build-up of rust and other unidentifiable substances in the sink and along the edges of the sink. *The laboratory refrigerator was dirty. There were dust and dirt particles on the inside of the refrigerator shelves. The bottom portion of the fridge had a large build-up of dust in it. *There was a corrugated cardboard box sitting on top of the laboratory refrigerator. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items). *Five blood pressure cuffs had a build-up of unknown particles on the Velcro portion of the cuff. *The floor located in front of the patient scale was broken and peeling up. The exposed portion of the floor could not be adequately cleaned and disinfected. *There were patient belongings and bags stored on the chaise wall located behind the dialysis machines. The staff members did not disinfect the contaminated chaise wall after exposure to the patient’s personal belongings. A review of the facility’s policy, “General Cleanliness and Infection Control Guidelines” with a published date of 11/04/2024 revealed, “PURPOSE: The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors ... POLICY: *All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms and offices. Walkways must be kept clear of debris and free of clutter. *Facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection ... *Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility. *Supplies or patient belongings should not be kept or stored behind the machine at the patient station ....” An interview with Staff # 1 and # 4 on 01/07/2025 at 1:45 PM confirmed the infection control findings within the in-center treatment area.”

“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: 48653 Based on observation, policy review, and staff interview, 1 (Staff # 16) of 2 direct care staff members failed to change gloves and perform hand hygiene between patient encounters and before touching dialysis equipment and sterile supplies. Also, the facility’s direct care staff failed to follow the facility’s “Cleaning and Disinfecting the Dialysis Station” policy. Findings include: During a tour of the facility’s in-center treatment area on 01/07/2025 at 11:00 AM with Staff # 1, the surveyor observed Staff # 16 (Registered Nurse) providing care to the patient at dialysis station # 4. Staff # 16 was observed touching the dialysis machine and keyboard with the same gloves that were used to touch the patient and the patient’s dialysis chair. Staff # 16 did not perform hand hygiene or change gloves between patient contact and contact with the dialysis machine and chair. A review of the facility’s policy, “Cleaning and Disinfecting the Dialysis Station” with a published date of 09/05/2023 revealed, “PURPOSE: The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. BACKGROUND: “The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross-contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses. Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious disease ... Hand hygiene must be performed after contact with the electronic devices and before contact with the patient ...” An interview with Staff # 1 on 01/07/2025 at 11:45 AM confirmed Staff # 16 did not change gloves and complete hand hygiene at the appropriate times and intervals as required in the facility policy, “Cleaning and Disinfecting the Dialysis Station”.”

“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: 48653 Based on observation, record review, and staff interview, the facility staff failed to ensure 2 (Syringe # 1 and Syringe # 2) of 2 medications maintained in the facility were properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to ensure 10 (Normal Saline Solution) of 10 intravenous fluids were within the manufacturer’s expiration date. The facility staff failed to follow the “Medication Preparation and Administration” policy. Findings include: During a tour of the facility’s in-center treatment area on 01/07/2025 at 11:00 AM, the surveyor observed 2 pre-drawn syringes of Heparin (a medication used to thin the blood) unsecured and accessible to unauthorized persons. Syringe # 1 was found unattended at dialysis station # 17 and Syringe # 2 was found unattended at dialysis station # 18. There were no patients undergoing treatment at dialysis stations # 17 or # 18 at the time of the observation. The surveyor observed 10 bags of 250 ml (milliliter) normal saline IV (intravenous) fluids with an expiration of “11/24”. The IV fluids were stocked in the medication cabinet and were available for patient use. A review of the facility’s policy, “Medication Preparation and Administration” with a published date of 02/06/2023 revealed, “PURPOSE: To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control ... PRE-DRAWING MEDICATIONS: Medications may be pre-drawn up to 4 hours prior to administration. These pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated medication storage area or refrigerated, if necessary, until delivery to the appropriate patient for administration ... Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded via Fresenius Kidney Care off-site return program or in accordance with local and/or state laws ...” An interview with Staff # 4 on 01/07/2025 at 11:20 AM confirmed the facility staff failed to properly safeguard medications and ensure all medications were within the manufacturer’s expiration date. Staff # 4 removed the expired medications from the medication storage cabinet.”

“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: 48653 Based on observation, policy review, and staff interview, the facility’s direct care staff failed to: A. perform proper disinfection of the dialysis machine and station after 1 (Patient # 3) of 1 patient completed treatment. B. label and date 2 (container # 1 and # 2) of 4 containers with 1:100 bleach solution with the correct date. Also, the facility’s direct care staff failed to follow the facility policy, “Cleaning and Disinfecting the Dialysis Station”. Findings include: A. During a tour of the facility’s in-center treatment area on 01/07/2025 at 11:00 AM with Staff # 1, the surveyor observed Staff # 17 cleaning dialysis machine # 5 located at station # 12. During the cleaning, Staff # 17 was observed cleaning the bottom of the dialysis machine with the same bleach wipe that the staff member cleaned the top of the machine with. Staff # 17 did not clean the keyboard on the dialysis machine. Also, Staff # 17 did not clean the Hansen connectors (connectors that connect to the dialyze). A review of facility policy titled, “Cleaning and Disinfecting the Dialysis Station” dated, 09/05/2023 revealed, “PURPOSE: The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross-contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day, and it is critical that these items be thoroughly cleaned and disinfected between uses. Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, the proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious diseases... The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station. Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment ... All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glistening wet and let air dry unless otherwise specified by the manufacturer .... Keep bleach solution in a location convenient to all dialysis machines/stations/treatment areas. Bleach solution will be stored in labeled, covered, opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air... Externally disinfect the dialysis machine including the keyboard, mouse and computer screen after each dialysis patient ...” An interview with Staff # 1 on 01/07/2025 at 11:45 AM confirmed the facility staff failed to follow facility policy, “Cleaning and Disinfecting the Dialysis Station” by not properly cleaning the dialysis station and machine after the patient completed treatment. B. During a tour of the facility’s in-center treatment area on 01/07/2025 at 11:00 AM with Staff # 1, the surveyor observed 2 of 4 bleach solution containers with 1:100 solution in them dated “12/07”. The surveyor asked Staff # 18 what date was on the bleach solution containers and Staff # 18 replied, “Oh, Staff #12 put the wrong date. It should say 01/07”. A review of facility policy titled, “Cleaning and Disinfecting the Dialysis Station” dated, 09/05/2023 revealed, “PURPOSE: The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross-contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day, and it is critical that these items be thoroughly cleaned and disinfected between uses. Also, the nature of dialysis treatments with frequent exposure to blood and body fluids, the proximity of patients and staff, and the immunocompromised status of dialysis patients make dialysis a high-risk area for spreading infectious diseases... The dialysis station could become contaminated with blood and other body fluids during treatment. After use, any non-disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach or EPA registered disinfectant before being removed from the dialysis station. Externally disinfect the dialysis machine with 1:100 bleach solutions after each dialysis treatment ... All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glistening wet and let air dry unless otherwise specified by the manufacturer .... Keep bleach solution in a location convenient to all dialysis machines/stations/treatment areas. Bleach solution will be stored in labeled, covered, opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air... Externally disinfect the dialysis machine including the keyboard, mouse and computer screen after each dialysis patient ...” An interview with Staff # 1 on 01/07/2025 at 11:45 AM confirmed the facility staff failed to follow facility policy, “Cleaning and Disinfecting the Dialysis Station” by not labeling the 1:100 bleach solution with the correct date.”

“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: 48653 Based on observation and staff interview, the facility staff failed to ensure that 1 of 1 bottle of the “Standard Buffer Solution 7.00 pH” (used to calibrate the conductivity meter) was within the manufacturer’s expiration date. Findings include: During a tour of the facility’s in-center treatment area on 01/07/2025 at 11:00 AM, the surveyor observed the facility’s tri-station (a station used to store solutions used in conductivity testing) to have an expired bottle of “Standard Buffer Solution 7.00 pH” with an expiration date of “October 2024”. An interview with Staff # 1 on 01/07/2024 at 1:30 PM confirmed the “Standard Buffer Solution 7.00 pH” was expired.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility staff failed to ensure that 1 (Patient # 1) of 1 patient was treated with respect, dignity, and recognition of individuality and personal needs. Also, the facility staff failed to follow the “Patient Rights and Responsibilities” policy. A review of the facility’s complaints and grievances revealed Patient # 1 submitted a complaint to the facility’s Area Team Lead (Staff # 4) which detailed concerns regarding the care and treatment Staff # 9 (CCHT) was providing on October 3rd, 2024. The complaint revealed, “ ...At 1:20 PM, Staff # 9 came to my chair, she put info into the dialyzer but did not check my BP (blood pressure) with the hand-held monitor. She came back at 1:40 PM. Again, she put info into the machine but did not take my BP with the handheld monitor. I gave her 2 chances to do her job. She failed both times. When she left my chair, I requested Staff # 11 to come talk to me. I know BP readings are essential to your treatment. Maybe Staff # 9 thought I did not notice her misconduct, I did! I know she doesn’t like me because I had her removed from my treatment. Rude and attitude! It’s evident that she has no regard for my treatment. I think she was being vindictive. She did not do her job, no BP was taken either time. She was unprofessional, negligent, and maybe unqualified and possibly a danger to me ....” During a tour of the facility’s In-Center Treatment Area on 01/07/2025 at 11:30 AM, two surveyors observed Staff # 9 being corrected by Staff # 1 (Clinical Manager) for leaving medications unsecured at the patient’s dialysis stations. During the correction, Staff # 9 became frustrated, threw her arms down, and stated, “What did I do wrong this time? This is the first I have heard of this.” Staff # 9 was rude and had an attitude in front of the patients being treated at Stations # 18 and # 19. The Clinical Manager had to request Staff # 9 leave the treatment floor and go into the office to calm down. Staff # 1 stated, “Let me go talk to her and calm her down”. A review of Staff # 9’s personnel file revealed 9 Corrective Action Forms. Corrective Action was taken on the following dates: *03/25/19 *12/18/19 *01/28/20 *03/08/21 *08/29/22 *04/10/23 *11/27/23 *06/24/24 *12/09/24 A review of the Corrective Action Form dated 12/18/19 revealed, “Reason for Corrective Action: Patients and partners first core value not exhibited in treatment of patient. Patient was not treated with respect during treatment on 12/16/19. A review of the Corrective Action Form dated 01/28/20 revealed, “Reason for Corrective Action: Patients and partners first core value not exhibited in treatment of patients. On each date (01/25/20, 01/27/20) a patient was not treated with respect or caring. A review of the Corrective Action Form dated 08/29/22 revealed, “Reason for Corrective Action: Verbal abuse, and bullying co-worker to the point that the co-worker had to leave work, and we had to find a replacement to cover the day.” A review of the Corrective Action Form dated 11/27/23 revealed, “Reason for Corrective Action: Staff member was yelling and cussing at another staff member on the treatment floor and made patients uncomfortable and one even signed off AMA.” A review of the Corrective Action Form dated 06/24/24 revealed, “Reason for Corrective Action: Staff member was yelling and cussing at another staff member on the treatment floor and made patients uncomfortable, several co-workers confirmed of her acting unprofessional, and also refuses to complete her LMS education after several reminders.” A review of Patient # 1’s medical record revealed the patient signed “Acknowledgement of Receipt of FMCNA Patient Rights and Responsibilities” on 02/14/23. A review of the “Patient Rights and Responsibilities List” published on 06/28/18 revealed, “You have the right to .... Care that is Respectful *Be protected from discrimination and or harassment based on race, color, national orgin, sexual orientation, gender identity, disability, age, sex and religion. *Be treated with dignity, consideration, respect and full recognition of your individuality and personal needs. This includes yours sensitivity to your psychological needs and ability to cope with ESRD ...” A review of the facility’s policy, “Patient Rights and Responsibilities” with a published date of 04/04/12 revealed, “PURPOSE: To comply with Federal Regulations that require dialysis facilities to: *Educate staff regarding the rights of dialysis patients. *Inform and educate all dialysis patients about their rights and responsibilities as a patient at the dialysis facility. *Ensure that patients’ rights are respected and protected by the facility ... The patient has the right to: 1. Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD ...” An interview with Staff # 1 on 01/07/2024 at 2:30 PM confirmed that Staff # 9 had many corrective actions regarding respect and dignity to co-workers and patients. Staff # 1 also confirmed that Staff # 9 had an attitude and was rude during correction on 01/07/2024.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility staff failed to A. ensure a clean and sanitary environment was monitored and maintained in the patient lobby, in-center treatment area, and supply room. Also, the facility staff failed to follow the facility policy, “General Cleanliness and Infection Control Guidelines”. (Cross Reference Tag V0111) B. ensure that patient nutritional supplies were not stored in the same refrigerator as medications. (Cross Reference Tag V0117) C. ensure all staff labeled and dated the bleach containers that were used for cleaning and disinfecting non-disposable equipment. Also, the facility failed to follow its policy on “Cleaning and Disinfection of the Dialysis Station.” (Cross Reference Tag V0122)”

“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: 48653 Based on observation, record review, and staff interview, the facility staff failed to ensure a clean and sanitary environment was monitored and maintained in the patient lobby, in-center treatment area, and supply room. Also, the facility staff failed to follow the facility policy, “General Cleanliness and Infection Control Guidelines”. This deficient practice had the likelihood to result in the transmission of infectious agents within the unit and between patients, staff members, and members of the public. The CDC defines a “sanitary environment” as an environment that meets the “Standard Precautions” for an inpatient hospital setting plus the more stringent precautions which are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. During a tour of the facility on 02/22/2024 at 9:30 AM the following infection control issues were observed: Patient Lobby The water fountain located in the patient lobby was covered with a red biohazard bag. The biohazard bag had a thick build-up of dust on it. The side of the water fountain had a thick build-up of black and gray dust on it. The water fountain had not been labeled as out of service and had not been properly maintained and cleaned. In-Center Treatment Area A thick build-up of dust was seen on the black cart stored next to the nurse’s station. There was a lockbox stored on the cart that the surveyor was able to wipe down. A large amount of dust came off the lockbox. The white table located in front of the clinic manager’s office had a thick build-up of dust on it. The table had 4 face shields stored on it. The face shields were also covered in a thick build-up of dust. The face shields were available for staff use and had not been properly cleaned and maintained. 1 of the 4 face shields was stored on the bottom shelf and there was a black broom and dustpan stored directly next to the table. The black rolling table located next to the nurse’s station had a thick build-up of dust on the bottom of it. The code cart was covered with a plastic covering. The plastic cover had a build-up of dust on it. When the surveyor removed the plastic cover, there was dust noted on the code cart and the suction canister located on top of it. The wheels of the code cart were also covered in dust and dirt build-up. The patient bathroom located in the in-center treatment area was found to have a plunger being stored upside down in the handrail. The plunger head was located directly next to the patient hand soap and clean sink. The patient lift was stored with the patient’s wheelchairs and personal items. The patient lift had been designated as clean. The lift was making direct contact with a patient’s wheelchair. The wall molding located next to the wheelchair storage area was damaged and missing. There was no way for the staff to properly clean the wall due to the damage to the wall molding and raw wood being exposed. A staff member’s stethoscope was found hanging in the area designated as “dirty sink”. It was not clear if the stethoscope was clean or dirty. A patient’s black suitcase was found stored on the wall chase just below the window. The suitcase was removed from the wall chase; however, the staff did not clean the wall chase after the suitcase had been removed. The gray trashcans located in between the patient stations had a white substance splashed on the side of them. The trashcans had not been cleaned by facility staff and were located next to the patient’s hemodialysis machines where there was a high potential for blood splatter. The blood pressure cuffs located at stations #13, # 14, # 16, and # 17 had fabric unknown debris affixed to the Velcro portion of the cuff. There was no way to know if the blood pressure cuffs had been disinfected. The medication refrigerator drawer which had Daptomycin stored in it had a build-up of black and brown substances in it. The drawer had dirt and debris in it and had not been cleaned or disinfected. The drawer at the nurse’s station located next to the patient entrance and exit was found to have staff members’ personal items stored inside it. There were lotion and clothing articles in the drawer. Isolation Room The isolation room located in the in-center treatment area had not been used since 01/29/2024 according to staffing sheets. The isolation room had old acid build-up on the floor. The wall box was dirty and had a build-up of old, dried acid inside of it. There were 2 sets of dialysis tubing, IV bags containing Normal Saline solution, and a red biohazard bag was left in the sink. The isolation room had not been cleaned after the last patient was treated on 01/29/2024. The patient in treated in the isolation room had an active COVID diagnosis at the time of treatment. Supply Room During a tour of the supply room on 02/22/2024 at 1:00 PM with Staff # 8, the surveyor observed: The lids of the containers that held the clean and sterile patient supplies had a thick build-up of black and gray dust and dirt. The epoxy floor of the supply room was chipping away and could not be properly cleaned and disinfected. Corrugated cardboard boxes were stored with sterile patient supplies. The corrugated boxes were stored over top of clean and sterile patient supplies. Cardboard boxes harbor parasites, insects, and microorganisms. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items). Back Door Entrance The back door entrance to the back hallway had sunlight coming through the bottom edge which would allow insects and rodents to enter the facility. A review of facility policy, “General Cleanliness and Infection Control Guidelines” with a publish date of 2/7/2022 revealed, “Purpose: The purpose of this policy is to provide guidance for FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors. Responsibility: All Staff Policy: All areas must be kept clean and organized, including but not limited to the treatment area, water/supply room, and offices. Walkways must be kept clear of debris and free of clutter. Facilities must adhere to any state-specific regulations that pertain to facility cleaning and disinfection. Eating, drinking, applying cosmetics or lip balm, and handling contact of lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets, or on countertops or benchtops where blood or other potentially infectious materials are present ... Facility staff are accountable for cleaning rooms/areas not assigned to contracted cleaning staff. Such cleaning should be done regularly using a schedule developed by the facility. Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station ...” An interview with Staff # 2 on 02/22/2024 at 1:30 PM confirmed the facility staff had not followed the facility policy, “General Cleanliness and Infection Control Guidelines” and had failed to maintain a sanitary environment in the patient lobby, in-center treatment room, and the supply room. Staff # 2 stated, “This is not what my clinics normally look like. I am disappointed.””

“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: 48653 Based on observation and interview, the facility staff failed to ensure that patient nutritional supplies were not stored in the same refrigerator as medications. During a tour of the facility’s in-center treatment area on 02/22/2024 at 9:35 AM, the surveyor observed 5 cartons of juice stored in the bottom drawer of the medication refrigerator. The refrigerator had a sign affixed to the outside of it that stated, “NO FOOD OR DRINKS”. The shelf that held the medication and juice had a black substance with dust particles and hair. An interview with Staff # 2 on 02/22/2024 confirmed the staff were not supposed to store any food or drinks in the medication fridge and that the staff had stored a patient’s juice in the refrigerator.”

“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: 29191 Based on observation and interview, the facility failed to ensure all staff labeled and dated the bleach containers that were used for cleaning and disinfecting non-disposable equipment. Also, the facility failed to follow its policy on “Cleaning and Disinfection of the Dialysis Station.” This deficient practice has the likelihood of contaminating dialysis surfaces with a less effective bleach solution. Findings include: During a tour of the treatment floor, the surveyor observed blue bleach solution containers that were not dated or labeled with the 1:100 bleach solution. Water pitchers were being used for the 1:10 bleach solutions and the pitchers were not labeled or dated. The blue bleach containers had 1 inch of solution. There was no way the solution would cover clamps for disinfection. There was another blue container containing numerous clamps. There was no label to determine if the clamps were clean or dirty. Also, there was no way to determine when the bleach solution was mixed due to no label on the container. The dialysis guideline for bleach solution was to be mixed every 24 hours in the dialysis setting. An interview with the Patient Care Technician#24 on 02/22/2024 at 10:15 Am was asked where the label was for the bleach container. Staff #24 stated, “The label should be on the container.” The surveyor had to point out that the label was torn off and there was no date or clarification of the type of bleach solution. A review of the facility’s policy titled, “Cleaning and Disinfection of the Dialysis Station,” dated 09/2023 revealed the following: “Keep bleach solution in a location convenient to all dialysis machines/stations. Bleach solution will be stored in labeled, covered opaque containers to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air. Bleach solution will be mixed in the appropriate dilution in accordance to the type of cleaning and disinfection required. When mixing bleach solutions, staff must wear PPE, including disposable gloves, face shield or eye protection with full side shields and fluid-resistant gowns. Refer to Mixing Bleach procedure.” An interview with Staff # 22 (Charge Nurse) on 02/22/2024 at 10:45 AM confirmed the bleach containers were not labeled with the type of bleach solution and there was no current date. There was no way to determine the date the bleach solution was mixed and the type of bleach solution.”

“PE-COMFORTABLE TEMPERATURE CFR(s): 494.60(c)(2) The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for the patients who are not comfortable at this temperature. This Standard is not met as evidenced by: 29191 Based on observation and interviews, the facility failed to ensure there was a comfortable temperature maintained in the patient treatment area. Findings included: A tour of the patient treatment area on 02/22/2024 at 10:20 AM revealed the following: * There was a noticeable temperature change in the facility from one part of the facility to the back part of the facility. Staff and patients complained of uncomfortable temperatures in the patient care area of the facility. There were 2 thermostats in the treatment area One thermostat was set at 67.5 and the other was set at 71.5. The surveyor observed all the patients had blankets and some type of head covering. Some of the patients were wearing gloves and one patient had on a face mask. Also, the surveyor observed that a CCHT was wearing a jacket under her gown. The treatment floor was cold even with wearing a gown per the surveyor. In an interview on 02/22/2024 at 10:15 AM Patients #5 and #6 acknowledged that the temperature was always cold on the treatment floor. Patients reported that complaints have been filed about the cold temperature being an issue, but nothing has been done. In an interview on 02/22/2024 at 10:30 AM Staff #25 confirmed the treatment floor was cold. Staff #25 stated. “I always wear a jacket under my gown because it stays very cold on the treatment floor. An interview with Biomedical on 02/22/2024 at 11:30 AM reported when using the temperature gun and pointing it at the air conditioner vent in the water room it showed 59 degrees. An interview with Staff #2 on 02/22/2024 at 1:30 PM confirmed that the plant operations staff member who prints out the facility temperature readings was unable to print out the readings due to an Internet outage. Staff #2 reported that the temperature of the thermostats is not the true reading of the facility temperature. An interview with Staff #1 (clinical Manager) acknowledged that the temperature was cold on the treatment floor but reported that the temperature was turned up after treatments were started. The surveyor observed the thermostat was set at 67.5 and the other thermostat was set at 71.5 when the surveyor entered the treatment floor at 10:01 AM. The treatment floor felt cold to the surveyors.”

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 The dialysis facility must provide or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter. This Standard is not met as evidenced by: 48653 Based on observation and interview, the facility staff failed to ensure that patient blood specimens were labeled according to facility practice. Also, the facility staff failed to ensure that lab tubes stored in the in-center treatment area were not expired. This deficient practice had the likelihood of resulting in the mislabeling of lab specimens and the potential for a patient’s lab specimen to be inaccurately labeled with a different patient’s identification. During a tour of the facility’s in-center treatment area on 02/22/2024 at 9:30 AM, the surveyor observed gold, green, and lavender top blood tubes with patient labels pre-printed on the tubes. The tubes were stored in a cabinet with other unlabeled lab tubes. The expiration date of the lab tubes could not be seen due to the patient sticker affixed to them. There was no way to determine when the lab tubes had been labeled. Also, there were 2 packs of green top lab tubes that were expired with an expiration date of “01/31/2024”. The lab tubes were stored in the cabinet and readily available for staff to use and had not been discarded. An interview with Staff # 2 on 02/22/2024 at 1:30 PM revealed the facility staff had not identified the expired lab tubes and had not labeled the tubes appropriately. Staff # 2 confirmed the staff should not be labeling the lab tubes far in advance due to the potential for a specimen to be incorrectly labeled.”