Fresenius Medical Care Belleair Dialysis Center

“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: 49691 Based on facility policy, observations and interviews the facility failed to ensure that staff adhere to hand hygiene to prevent possible cross contamination of microorganisms in one (Staff C, PCT) out of four staff members observed. Findings included: Reviewed the policy and procedure titled, “Hand Hygiene”, #47664, published 11/06/2023 revealed The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination ...Decontamination using alcohol- based hand rub or by washing hands with antimicrobial soap and water- before and after direct contact with patient, entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, immediate after removing gloves ... On 03/03/2025 between 9:03 AM Staff C, PCT (Patient Care Technician) was at the computer on station #5. She removed her gloves, and reapplied gloves went to nursing station at 9:05 AM and spoke with the nurse. The Staff C, PCT went to station # 8 ’ s computer after on the computer she removed her gloves and reapplied new gloves and went to station #15 ’ s computer at 9:07 AM. She removed her gloves and applied new gloves and went to station # 8 at 9:08 AM and adjusted the blood pressure cuff on the patient. She touched the computer and the patient and then went back to the computer. She removed her gloves and at 9:09 AM applied new gloves at station # 13. At 9:11 AM Staff C went to the nursing station with gloved hands and returned to station # 13. Hand hygiene was not performed during this observation. On 03/03/2025 at 3:44 PM Staff C, PCT had gloves on, and assisted a patient in station # 15 and did the blood pressure, she removed the blood tubing from the dialysis machines and placed the tubing in the biohazard bins with no lid. Staff C, PCT did not remove her gloves and walked to the front to get the patients weight and escorted him out. Still wearing the same gloves, she assisted another patient leaving by stretcher with the transport service to station 16. Staff C did not change her gloves.”

“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: 49691 Based on observations, policies, and interviews, the facility failed to ensure that equipment and supplies brought into the patient station area were cleaned, disinfected or discarded after the patient completed treatment and left facility in 7 (#11, 13, 16, 14, 20, 19, 18) out of 20 stations. Findings included: Reviewed the policy and procedure titled, “Dialysis Precautions”, published 01/04/2012 ...general approach: approach all patients as if they are infectious, approach all blood, body fluids, tissues, needles and sharps as if they are contaminated, approach all used dialyzers as if they are contaminated, Approach all supplies and equipment used for a patient ’ s treatment as if they are contaminated ...clean area: an area designated for clean and unused equipment, supplies and medications. Dirty area: an area where this is a potential for contamination with blood or body fluids and area where contaminated or used supplies, equipment blood supplies or biohazard containers are stored or handled ... On 03/03/2025 at 10:10 AM single use tape was noted to be stored in the blood pressure cuff baskets on the dialysis machines in station #11, 13, 16, 14, 20, 19, 18. During an interview on 03/03/2025 at approximately 11:00 AM with Staff M, Director of Operations she stated, “the tape should be thrown away after each patient use”. Photographic evidence obtained.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 49691 Based on observations, policies, and interviews, the facility did not ensure that common supplies were kept away from patient care areas to prevent the contamination of the supplies in 20 out of 20 stations. Findings included: Reviewed the policy and procedure titled, “Dialysis Precautions”, published 01/04/2012 ...general approach: approach all patients as if they are infectious, approach all blood, body fluids, tissues, needles and sharps as if they are contaminated, approach all used dialyzers as if they are contaminated, Approach all supplies and equipment used for a patient ’ s treatment as if they are contaminated ...clean area: an area designated for clean and unused equipment, supplies and medications. Dirty area: an area where this is a potential for contamination with blood or body fluids and area where contaminated or used supplies, equipment blood supplies or biohazard containers are stored or handled ... Reviewed the policy and procedure titled, “General Cleanliness and Infection Control Guidelines”, #47685, published 07/01/2024 ...Supplies or patient belongings should not be kept or stored behind the machine at the patient station. On 03/03/2025 during the tour of the dialysis unit from approximately 8:30 AM to 11:30 AM observed common supplies such as tubing, flushes, gauze, needles, catheter packs, etcetera located within the patient stations on the shelf behind the patient recliners and dialysis machines. During a discussion on 3/03/2025 at 11:10 AM with Staff M, Director of Nursing regarding clean supplies being located in the splash zone at each station, she did not say anything but went out to remove all the supplies patient care areas. Photo evidence obtained.”

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 49691 Based on observations, policies and interviews the facility did not ensure the patient dialysis treatment area was free from the spread of potentially infectious waste that was discarded and open to the elements while in the biomedical waste containers in three of three biomedical waste containers. Findings included: Reviewed the policy and procedure title, “General Cleanliness and Infection Control Guidelines”, #47685, published 11/04/2024 ... Regulated medical waste shall be placed in a container that is in accordance with OSHA bloodborne standard 1910.1030 and is closeable, leak proof and labeled and /or color coded. Regulated waste shall be placed in containers which are: Closable, constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping, labeled and colored, closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping ... Reviewed the policy and procedure titled, “Dialysis Precautions”, published 01/04/2012 ... Dirty area: an area where this is a potential for contamination with blood or body fluids and area where contaminated or used supplies, equipment blood supplies or biohazard containers are stored or handled ... During a tour of the patient dialysis area on 03/03/2025 at approximately 8:40 AM observed 3 biohazard receptacles without lids incapable of closure, that contained the discarded microbiological waste (may contain concentrated forms of infectious products such as blood or bodily fluids). A biohazard receptacle (#1) without a lid incapable of closure located between stations #2 and #6 nursing area in which patient coming in for dialysis treatment in station 1, 2, 6, and 7 would pass the open bin. The Biohazard bin (#2) with no lid capable of closure located between station #14 and #19 in the nursing area in which patient coming in or leaving the area pass by. The biohazard bin (#3) with no lid was located between station #1 and station #7 with Station #1 being the Candida Auris (contagious fungal infection spread through contact and indirect contact) station did not have lids to contain the discarded microbiological waste (may contain concentrated forms of infectious products such as blood or bodily fluids). On 03/03/2025 at 10:15 AM observed Staff B, CCHT changed the IVF (Intravenous fluids) bag to a new one and placed the IVF with blood in the biohazard container that did not have a lid to contain microbiological waste located between patients station 2 and 6 in the nursing area. On 03/03/2025 3:44 PM observed Staff C PCT at station 15 where she removed the blood tubing from the dialysis machines and placed them in the biohazard bin that did not have a lid to contain the waste. During an interview on 03/03/2025 at approximately 11:00 AM with Staff M, Director of Operations she stated that the bio-bins should have a lid. During an interview on 03/04/2025 at 8:00 AM staff N Director of Operations stated, “I am also aware of the biohazard bins not having lids on them we replaced them yesterday from another dialysis center”. Photo evidence #6, #11, and #20”

“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: 49691 Based on observations, policies, and interviews the facility failed to ensure that equipment brought into the patient station area was disinfected after the patient completed treatment and left facility in 2 of 2 observations. Findings included: Reviewed Policy and procedures titled, “General Cleanliness and infection control Guideline”, #47685, published 07/01/2024 ...The purpose of the policy is to provide guidance for Fresenius Kidney Care staff on preventing the spread of infectious disease and maintaining a clean, safe and aesthetically pleasant environment ... Reviewed policy and procedure title, “Cleaning and Disinfecting the Dialysis Station”, #47806, published 09/05/2023 ...Dialysis station- Area including the dialysis machine chair/ bed and other reusable equipment or supplies utilities during dialysis treatment ...Equipment in the dialysis station may include (but not limited to ) ...Dialysis machine/ cycler and attachments such as IV pole, BP cuff and hand sanitizer/ holder, organizer, chair/ bed ... individual television and remote ...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 ... On 03/03/2025 at 8:40 AM during a flash tour, an unused oxygen concentrator (uncovered) was noted on the floor at station #3. During an interview on 03/03/2025 at 10:20 AM with staff B Certified clinical hemodialysis technician (CCHT) stated that “the oxygen concentrator was there when the patient came in for dialysis treatment.” On 03/04/2025 at approximately 10:45 AM an unused dirty oxygen concentrator was observed next to station #7 with a patient sitting in the recliner. During an interview on 03/04/2025 at approximately 10:45 AM with Staff D she stated, “the oxygen concentrator was for the last patient that was at station #7. Photo evidence obtained.”

“IC-HBV-ISOLATION-STAFFING CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another. This Standard is not met as evidenced by: 49691 Based on policies, observations and interviews the facility failed to inform staff of patients with Candida Auris infection status to prevent cross contamination in one (patient #4) of 39 patients observed. Findings included: Reviewed the Policy and Procedure titled, “Candida Auris Infection Control”, #64421, published 02/28/2024 ...Preventing Candida Auris (C. Auris) transmission requires diligent adherence to infection control recommendations by all healthcare personnel who care for the patient ...It is recommended that patients dialyze on the last shift of the day and be taken directly to the dialysis station upon arrival to the facility. The patient should remain in the station until departure from the facility. Patients will be placed in the isolation room if there are no Hepatitis B positive patients on the facility census. If a separate room is not available, dialyze the patient at a station with a few adjacent stations as possible ...dedicated non-disposable equipment (stethoscope, blood pressure cuff ...) place non-disposable dedicated supplies in a plastic bag to prevent use on no-infected patients. Label bag with the patient ’ s medical record number. Separate personal protective equipment (PPE) when performing any direct patient care activities. The dedicated PPE must be donned when caring for the C. Auris patient and doffed when moving to care for other patients, The dedicated PPE cannot be stored with PPE worm when caring for other patients ...When possible limit the number of staff entering and existing the dialysis station or room ... During a discussion on 03/04/2025 at 10:30 AM with Staff D, PCT (Patient Care technician) regarding Candida Auris (C. Auris), she stated that she was educated. She was shown the schedule for 03/04/2025 and she stated none of them have C Auris but disclosed that patient #4 has severe acute respiratory syndrome (SARS). She stated Staff E, RN (Registered Nurse) told her that. She stated she did “not really” know what SARS was. She was informed Patient #4 had C Auris and then she stated that she might have misunderstood what the nurse has said. She stated that the nurses would inform the staff if any patient had C Auris. On 03/04/2025 at 11:40 AM Patient # 4 arrived in the center, at 11:20 AM and was taken to station #2 which was designated as a Candida auris station at 12::03 PM. During an interview on 03/04/2025 at 12:12 PM with Staff F, PCT said there is a protocol for C. Auris and that the nurses would let them know if the patient had C. Auris He did disclose that he took care of Patient #4 and was not informed that she had C. auris until the next day. He stated he did not change the gown between patient #4 and other patients. He stated that during one treatment she was at station 5, then the other treatments at station 13. During an interview at 03/04/2025 at 12:30 PM with Staff Certified Clinical Hemodialysis technician (CCHT) he stated “what I am supposed to say is that as soon as I finish with taking care of a Candida auris patient I remove my gown and hang it up. But to be honest I am too busy to remove my gown after caring for the patient.” When the patient was at station # 13, they are to hang the gown on the pole on the dialysis machine where the IVF (Intravenous fluids) hang for the patient. During an interview on 03/04/2025 at approximately 1:00 PM with Staff N, Director of Operations stated that patient #4 sitting in the lobby with 2 other patients instead of being taken straight to her dialysis station and she stated, “the policy says it is recommended, and she [Patient #4] rides a city bus.” During discussion about the policy stating that if a separate room is not available, dialyze the patient at a station with as few adjacent stations as possible. Staff N, Director of Operations said she can not put the patient on third shift because they do not have a third shift due to census and station 1 is the only thing that she thinks will work, she said that she moved the patient that was to be in the station next to her to the only other station open for now.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 49691 Based on facility policies, observation and interviews, the facility failed to ensure that the medication was dispensed and administered with aseptic techniques in one (heparin) of two medications administered. Findings included: Reviewed the policy and procedure title, “Medication preparation and administration”, # 47488, published 02/06/2023 ...When preparing medications if the vial is not used immediately in its entirely, the nurse must place the date and time the vial was opened on the medication label along with their initials ... a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol. Allow to dry before inserting a device into the vial ... disinfect IV ports prior to accessing, using friction and 70% alcohol ... Allow to dry prior to accessing ... On 03/03/2025 at 9:37 AM observed Staff A, Registered Nurse (RN) pick up an open Heparin multi dose vial with no date or initials when opened. She withdrew heparin without wiping the stopper with alcohol prior to removal of medicine. Staff A, RN administered the medication through the Central Venous Catheter (CVC) to Patient #10 without wiping the injection port with antiseptic prior to injecting the medication. During an interview on 03/04/2025 at 8:00AM with Staff N, Director of Operations regarding above she stated, “I have nothing to say other that it should not have happened”.”

“ENVIRONMENT-ACCESS TO PORTS/METERS CFR(s): 494.40(a) 8 Environment: access to ports/meters The layout of the water purification system should provide easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance. This Standard is not met as evidenced by: 49691 Based on observation, policy review and interviews the facility failed to ensure the water room had easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance in 1 of 1 water room. Review of Policy and procedures titled, “General Cleanliness and infection control Guideline”, #47685, published 07/01/2024 ...The purpose of the policy is to provide guidance for Fresenius Kidney Care staff on preventing the spread of infectious disease and maintaining a clean, safe and aesthetically pleasant environment ... On 3/3/2025 at approximately 09:34 AM in an observation of the water room, containing the reverse osmosis machine for hemodialysis usage, observed a tall ladder extending into the ceiling blocking the access area for chloramine testing. There were many salt pellet bags blocking carbon tanks. There were several areas that appeared to have prior leaks. A large cardboard box containing a new carbon tank was also blocking access to the designated water sampling site. A used Phoenix meter (measures conductivity and pH) was laying on top of the lid of the bicarbonate mix and not in its designated holder. Photographic evidence obtained. On 3/3/2025 @ 10:30 AM observed Staff B, CCHT (Certified Clinical Hemodialysis Technician) and Staff A, Charge Nurse obtain a chloramine test. They had to navigate through the Ladder and other objects in the room to obtain the result. In an interview with the area director of Biomedical services on 3/3/2025 at approximately 2:30 PM he explained that they had some work being done on the ceiling in the water room, had several deliveries that day. Explaining that they didn’t have an opportunity to get to the room. He stated that they are in the process of obtaining a new system in 2025.”

“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: 49691 Based on observation, record review and interview the facility failed to ensure independent verification of conductivity (The degree of which a specific material conducts electricity) and pH (is used to measure the acidity or alkalinity of water) prior to initiation of dialysis in 2 of 3 patients. A review of the policy Checking Conductivity and pH of Final Dialysate, published 2/3/25 stated Purpose . . .The purpose of this policy is to provide guidance to verify final dialysate conductivity and pH prior to initiating hemodialysis treatments and during treatments if required ...Policy Two staff members will verify the conductivity and pH prior to each patient ’ s treatment... Dialyzers primed for longer than two hours must again be recirculated using increase ultrafiltration rate for 5 minutes prior to initiation of patient dialysis treatment ... On 03/03/2025 at 9:56 AM observed staff E Register Nurse (RN) initialing patient #9 central venous catheter. the dialysis machine was started at 10:03 AM and initiation of patient #9 to the dialysis machine at 10:05 AM without checking the pH. On 3/3/2025 at 10:00 am, Staff C, PCT (Patient Care technician) prepared a Hemodialysis machine in Pod 15. She placed a patient on hemodialysis without confirming and obtaining an independent verification of pH. There were no strip tests in the vicinity to utilize for testing. On 03/03/2025 at 10:05AM Staff E, RN readied the dialysis station for a patient. Independent verification pf pH was not completed. During an interview on 3/3/2025 at 0930am Staff B, CCHT (Certified Clinical Hemodialysis Technician) stated that independent verification of pH with a pH test strip is done prior to placing the patient in the chair in preparation for their dialysis treatment. In an interview on 03/03/2025 at 10:10 AM with Staff E, RN, after the observation, she stated that it is ok to not have the dialysis machine running for greater than 5 minutes prior to hooking up the patient. She stated she did complete the pH independent testing.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 49691 Based on facility policies, observations, and interviews the facility did not ensure the privacy of patient’s protected health information , discussion in two (Staff K, Nurse Practioner (NP) and Staff L, Medical Doctor (MD) of two Staff observed. Findings included: On observations noted during the initial Flash tour of the facility @ 0845 on 3/3/2025 Personal health information on sheets of paper in the patient pre dialysis packs on several of the counters surrounding the dialysis pods. See photographic evidence labeled #2, & #4. Reviewed policy and procedure titled, “patient rights and responsibilities”, published 0404/2012 ...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, 2. Received all information in a way that he or she can understand; 3. Privacy and confidentiality in all aspects of treatment; 4. Privacy an confidentiality in personal medical records’ ... Patient have the right to privately discuss their condition and treatment. There should be ready access to a room in the facility where patients and / or family meetings may be held in private ... On 03/04/2025 at 11:54 AM Staff K, NP walked past the registration desk and into the lobby and rounded on a patient. Staff L MD also noted to be rounding in the lobby, discussing treatment with a patient. There were 3 patients observed in the lobby at the time. During an interview on 03/04/2025 at 11:55 AM with Staff H, Administrative Assistant stated that the nurse practitioner and the MD is rounding in the lobby. They are not supposed to be doing that. During an interview on 03/04/2025 at approximately 1:00 PM with Staff N, Director of Operations stated, “we need to get the medical director involved because they can not be doing tha”

“MD RESP-ENSURE IVD P&P FOLLOWED CFR(s): 494.150(c)(2)(ii) The medical director must- (2) Ensure that- (ii) The interdisciplinary team adheres to the discharge and transfer policies and procedures specified in §494.180(f). This Standard is not met as evidenced by: 44048 Based on interview and record review the medical director failed to ensure the facility’s interdisciplinary team followed a discharge and transfer policy that complied with § 494.180(f). Findings included: 1. On 2/29/2024 at 11:00 am, the Director of Operations (DO) provided a copy of an updated facility plan of correction (POC) and “Candida auris Infection Control” policy and procedure. The DO stated the “Candida auris Infection Control” policy and procedure, dated 2/28/2024, was scheduled to be approved that day and would be effective by 3/1/2024. The updated facility POC was reviewed with the DO. The POC indicated: a. Patient #2 was transferred to another provider on 8/22/2023, as this clinic could not meet the patient’s medical needs regarding Candida Auris. Patient #3 was transferred to another provider on 10/18/2023, as this clinic could not meet the patient’s medical needs regarding Candida Auris. Patient #4 was transferred to another provider on 12/20/2023, as this clinic could not meet the patient’s medical needs regarding Candida Auris. Patient #2 and Patient #3 was (sic) transferred to another physician due to their medical needs, particularly concerning Candida Auris, which could not be addressed due to staffing shortages ...the patients have transitioned to another provider and physician ...this decision was not initiated by the patients themselves Patient #4 opted to remain under the care of our physician ...the patient have (sic) transitioned to another provider ...this decision was not initiated by the patient themselves ... b. “ ...The Governing Body met on 12/21/2023 to approve the following process: Any patient identified with Candida Auris (active or colonized) will be transferred to a sister clinic that is trained and capable of caring for those patient’s medical needs ...” c. “ ...The GB (governing body) will meet on 2/29/2024 to review and approve the following: Candida Auris Infection control Policy ... Per the policy infection control precautions are the same for both infection and colonization with Candida Auris. Per the policy contact precautions will be used to care for Candida Auris patients, including non-disposable equipment and separate personnel protective equipment. Per the policy Candida Auris designated area and non-disposable equipment will be disinfected between patients ... During the meeting the Governing Body focused on discussing and addressing staffing challenges within the dialysis facility. To address this issue, we have implemented the following interim measures: ...Patient Transfer: Patients diagnosed with Candida Auris infections are being transferred ...to provide specialized care for this condition ...” d. In a concurrent interview with the DO she stated if in the next few days one of their current patients were to be diagnosed carrying Candida Auris, the facility, as directed by the Senior Regulatory Manager, “would transfer (the patient) and we would follow the IVD process.” The DO stated the transfer and IVD process would be initiated even though the “Candida Auris Infection Control” policy and procedure would have been in effect by the next day and that their nurses were trained in contact precautions. The DO further stated that if the facility received a referral for admission of a patient with Candida Auris carrier status the Senior Regulatory Manager’s instruction was, “we would not admit them...refer to another facility.” 3. On 2/29/2024 at 11:30 a.m., the “Routine and Involuntary Patient Discharge” policy and procedure, dated 9/4/2019, was reviewed with the DO and the Facility Administrator (FA). The policy and procedure indicated: a. “...The Medical Director shall ensure that no patient is involuntarily discharged, or transferred from the facility unless: 1. The Patient or payer no longer reimburses the facility... 2. The facility ceases to operate. 3. The transfer is necessary for the patient’s welfare because the facility can no longer meet the patient’s documented medical needs... 4. The patient’s behavior is deemed disruptive... 5. The patient’s behavior is an immediate and severe threat... 6. The patient’s attending physician...has notified patient that medical services are being terminated and there is no other attending physician at the facility available or willing to accept the patient...” b. “...Patients may not be discharged for not meeting facility indicator targets or for any other reason other than those reasons outlined in this policy...” c. “...Discharge: Facility Unable to Meet Needs. If a patient’s medical condition is deemed to require non-routine, extensive monitoring, or other interventions that are not available in the facility, transfer or discharge of the patient may be necessary. All reasonable alternatives for continuing to provide care to the patient in the facility must be considered before discharge or transfer occurs...” d. A concurrent interview was conducted with the DO and the FA. The DO and the FA stated Candida Auris carrying patients required contact precautions during dialysis treatment. The DO and the FA stated the required contact precautions and infection control interventions for Candida Auris carrier patients were similar if not the same with MRSA (methycillin-resistant staphylococcus aureus - bacteria) carrier patients. The DO and the FA stated the required infection control interventions and transmission based precaution for Candida Auris carrier patients were actually routine. The DO and FA were unable to provide any non-routine requirements for the dialysis treatment of Candida Auris carrying patients. The DO and the FA also stated Candida Auris carrying patients did not require extensive monitoring nor other interventions that are not available in the facility. The FA stated if one of their current patients were diagnosed to be with MRSA, they would not transfer the patient and would continue to provide dialysis treatment in the facility. The DO and FA both agreed the transfer and involuntary discharge of Candida Auris carrying patients were not consistent with the facility policy and procedure and regulatory requirement §494.180(f).”

“GOV-GB&MED DIR RESP STAFF FLW DC/TRANSFER P&P CFR(s): 494.180(f)(1)-(3) The governing body must ensure that all staff follow the facility’s patient discharge and transfer policies and procedures. The medical director ensures that no patient is discharged or transferred from the facility unless - (1) The patient or payer no longer reimburses the facility for the ordered services; (2) The facility ceases to operate; (3) The transfer is necessary for the patient’s welfare because the facility can no longer meet the patient ’ s documented medical needs; This Standard is not met as evidenced by: 44048 Based on interview and record review the governing body failed to ensure patients were not transferred or discharged involuntarily due to their Candida Auris carrier status. Findings: 1. On 2/29/2024 at 11 am, the Director of Operations (DO) provided a copy of an updated facility plan of correction (POC) and “Candida auris Infection Control” policy and procedure. The DO stated the “Candida auris Infection Control” policy and procedure, dated 2/28/20224, was scheduled to be approved that day and would be effective by 3/1/2024. The updated facility POC was reviewed with the DO. The POC indicated: a. Patient #2 was transferred to another provider on 8/22/2023, as this clinic could not meet the patient’s medical needs regarding Candida Auris. Patient #3 was transferred to another provider on 10/18/2023, as this clinic could not meet the patient’s medical needs regarding Candida Auris. Patient #4 was transferred to another provider on 12/20/2023, as this clinic could not meet the patient’s medical needs regarding Candida Auris. Patient #2 and Patient #3 was (sic) transferred to another physician due to their medical needs, particularly concerning Candida Auris, which could not be addressed due to staffing shortages ...the patients have transitioned to another provider and physician ...this decision was not initiated by the patients themselves Patient #4 opted to remain under the care of our physician ...the patient have (sic) transitioned to another provider ...this decision was not initiated by the patient themselves ... b. “ ...The Governing Body met on 12/21/2023 to approve the following process: Any patient identified with Candida Auris (active or colonized) will be transferred to a sister clinic that is trained and capable of caring for those patient’s medical needs ...” c. “ ...The GB (governing body) will meet on 2/29/2024 to review and approve the following: Candida Auris Infection control Policy ... Per the policy infection control precautions are the same for both infection and colonization with Candida Auris. Per the policy contact precautions will be used to care for Candida Auris patients, including non-disposable equipment and separate personnel protective equipment. Per the policy Candida Auris designated area and non-disposable equipment will be disinfected between patients ... During the meeting the Governing Body focused on discussing and addressing staffing challenges within the dialysis facility. To address this issue, we have implemented the following interim measures: ...Patient Transfer: Patients diagnosed with Candida Auris infections are being transferred ...to provide specialized care for this condition ...” d. In a concurrent interview with the DO she stated if in the next few days one of their current patients were to be diagnosed carrying Candida Auris, the facility, as directed by the Senior Regulatory Manager, “would transfer (the patient) and we would follow the IVD process”. The DO stated the transfer and IVD process would be initiated even though the “Candida Auris Infection Control” policy and procedure would have been in effect by the next day and that their nurses were trained in contact precautions. The DO further stated that if the facility received a referral for admission of a patient with Candida Auris carrier status the Senior Regulatory Manager’s instruction was, “We would not admit them...refer to another facility.” 3. On 2/29/2024 at 11:30 a.m., the “Routine and Involuntary Patient Discharge” policy and procedure, dated 9/4/2019, was reviewed with the DO and the Facility Administrator (FA). The policy and procedure indicated: a. “...The Medical Director shall ensure that no patient is involuntarily discharged, or transferred from the facility unless: 1. The Patient or payer no longer reimburses the facility... 2. The facility ceases to operate. 3. The transfer is necessary for the patient’s welfare because the facility can no longer meet the patient’s documented medical needs... 4. The patient’s behavior is deemed disruptive... 5. The patient’s behavior is an immediate and severe threat... 6. The patient’s attending physician...has notified patient that medical services are being terminated and there is no other attending physician at the facility available or willing to accept the patient...” b. “...Patients may not be discharged for not meeting facility indicator targets or for any other reason other than those reasons outlined in this policy...” c. “...Discharge: Facility Unable to Meet Needs. If a patient’s medical condition is deemed to require non-routine, extensive monitoring, or other interventions that are not available in the facility, transfer or discharge of the patient may be necessary. All reasonable alternatives for continuing to provide care to the patient in the facility must be considered before discharge or transfer occurs...” d. A concurrent interview was conducted with the DO and the FA. The DO and the FA stated Candida Auris carrying patients required contact precautions during dialysis treatment. The DO and the FA stated the required contact precautions and infection control interventions for Candida Auris carrier patients were similar if not the same with MRSA (methycillin-resistant staphylococcus aureus - bacteria) carrier patients. The DO and the FA stated the required infection control interventions and transmission based precaution for Candida Auris carrier patients were actually routine. The DO and FA were unable to provide any non-routine requirements for the dialysis treatment of Candida Auris carrying patients. The DO and the FA also stated Candida Auris carrying patients did not require extensive monitoring nor other interventions that are not available in the facility. The FA stated if one of their current patients were diagnosed to be with MRSA, they would not transfer the patient and would continue to provide dialysis treatment in the facility. The DO and FA both agreed the transfer and involuntary discharge of Candida Auris carrying patients were not consistent with the facility policy and procedure and regulatory requirement. 4. Review of the facility “General Policy Statement” dated 4/5/2021 indicated, “...Where medically appropriate and consistent with [facility] policy, facilities shall admit and treat all patients referred by an attending physician on the facility’s medical staff without regard to race, color, religion...disability...genetic predisposition or carrier status, or any other legally protected characteristics...” 5. Review of the facility “Patient Nondiscrimination” policy and procedure dated 8/26/2020 indicated, “...It is the policy of [facility] that it does not exclude, deny benefits to, or otherwise discriminate against any person on the grounds of race, color...disability...genetic predisposition or carrier status, or any other legally protected characteristic in admission to, participation in, or the receipt of the renal services and benefits under any of its programs and activities, and in staff and employee assignments...” 6. Review of Infection Prevention and Control for Candida Auris guidance from the Centers for Disease Control (CDC), last reviewed 1/17/2023, revealed setting specific considerations for dialysis facilities to include: -Inform and educate appropriate personnel about the presence of a patient with C. auris and the need for specific infection control measures. -Use alcohol-based hand sanitizer as the preferred method for cleaning hands when they are not visibly soiled. If hands are visibly soiled, wash with soap and water. Wearing gloves is not a substitute for hand hygiene. -Wear gowns and gloves using proper donning and doffing techniques when caring for patients with C. auris or touching items at the dialysis station. Remove gowns and gloves, dispose of them carefully, and perform hand hygiene when leaving the patient ’ s station. -Minimize exposure to other patients by dialyzing the patient at a station with as few adjacent stations as possible (e.g., at the end or corner of the unit), and consider dialyzing the patient on the last shift of the day. Thoroughly clean and disinfect the dialysis station (e.g., chairs, side tables, machines) between patients by using products approved for use against C. auris (see above for more information about these disinfectant products and List P). -Properly clean and disinfect reusable equipment brought to the dialysis station after each use. https://www.cdc.gov/fungal/candida-auris/c-auris-infection-control.html”

“PR-RECEIVE WRITTEN NOTICE 30 DAYS PRE IVD CFR(s): 494.70(b)(2) The patient has the right to- (2) Receive written notice 30 days in advance of an involuntary discharge, after the facility follows the involuntary discharge procedures described in §494.180(f)(4). In the case of immediate threats to the health and safety of others, an abbreviated discharge procedure may be allowed. This Standard is not met as evidenced by: 28028 Based on review of medical records, staff interview and policy and procedures it was determined the facility failed to ensure the patient received written notice 30 days in advance of an involuntary discharge and failed to follow the involuntary discharge procedures for three (#2, #3, #4) of three patients discharged from the facility. Findings included: Review of the facility policy titled “Routine and Involuntary Patient Discharge Procedure” revealed a sequential approach to non-immediate or immediate involuntary discharge. The steps to be followed are as follows: 1. Inform the Director of Operations. 2. Reach out to Corporate Clinical Services for review. 3. Notify and secure a written order from both the Medical Director and attending physician for discharge. 4. Upon completion of the preceding steps, generate a 30-day notice of discharge (Patient Discharge Letter) for the patient. This letter should outline the reasons why the facility can no longer meet the patient’s medical needs. 5. Furnish the patient and their representative with a list of alternative treatment facilities in the area, assist in transferring the patient’s care to another facility, and duly document these actions in the medical record. 6. Notify the ESRD Network and State agency on the same day the discharge letter is provided to the patient. Review of facility documents for patient discharges revealed patient #2 was discharged on 12/20/2023, patient #3 was discharged on 8/22/2023, and patient #4 was discharged on 10/18/2023. An interview was conducted with the Director of Operations (DO) on 1/16/2024 at 10:23 AM. It was determined that patients #2, #3, and #4 had gone to the hospital and subsequently undergone screening for Candida Auris (C. Auris). Each of the patients results were positive for colonization of C. Auris. The DO confirmed that, due to the positive results, these patients were unable to return to the facility for dialysis, and they were obliged to seek treatment at another facility. The DO confirmed following additional consultations with the Network and Corporate Regulatory Compliance staff, it was concluded that any patient unable to have their medical needs addressed, as illustrated in the aforementioned cases, would be subjected to the facility’s policy for involuntary discharge. On 1/16/2024 at 12:40 PM an interview was conducted with the facility’s Medical Director. He confirmed if the facility could not provide care to meet the patient’s needs, as in the case of a patient that tested positive for colonization of C. Auris, the patient would be involuntarily discharged. He stated this is not a facility policy but rather a Corporate policy. At 12:40 PM on 1/16/2024, an interview was held with the Medical Director of the facility. The Medical Director affirmed that in situations where the facility cannot offer the necessary care, such as in the instance of a patient testing positive for C. Auris colonization, involuntary discharge would be implemented. He stated this is not a facility policy but rather a Corporate policy. During the interview with the Director of Operations (DO) at 12:30 PM on 1/16/2024, it was conveyed that the facility lacks a specific policy for the care and treatment of patients with C. Auris. The Infection Prevention Lead from the Department of Health later verified that patients testing positive for C. Auris colonization should receive treatment with contact precautions. Subsequently, in an interview with a Registered Nurse (RN) at 9:30 AM on 1/16/2024, it was affirmed that they have previously administered care to patients necessitating contact precautions. An interview was held with the Director of Clinical Services/Infection Prevention and the Senior Director of Regulatory Affairs on 1/16/2024 at 1:52 PM. It was verified in the course of the interview that patients with C. Auris colonization would not receive treatment at the facility and would instead face involuntary discharge. The confirmation was provided that these patients would be given a 30-day notice, during which they would not be treated at the facility. The interviewees expressed their intention to review the involuntary discharge policy to assess its accuracy and appropriateness.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 28028 Based on review of medical records, staff interview and policy and procedures it was determined the medical director failed to ensure the patient received a 30-day notice of the planned discharge for three (#2, #3, #4) of three patients discharged from the facility. Findings included: Review of facility documents for patient discharges revealed patient #2 was discharged on 12/20/2023, patient #3 was discharged on 8/22/2023, and patient #4 was discharged on 10/18/2023. An interview was conducted with the Director of Operations (DO) on 1/16/2024 at 10:23 AM. It was determined patient #2, #3, and #4 had gone to the hospital and were screened for Candida Auris (C. Auris). Each of the patients results were positive for colonization of C. Auris. The DO confirmed the patients were unable to return to the facility for dialysis due to the positive result and the patients were left to find alternative treatment at another facility. The DO confirmed after further discussions with the Network and Corporate Regulatory Compliance staff, it was determined, that any patient that could not have their medical needs met, as in the examples above, the facility would follow the policy for involuntary discharge. On 1/16/2024 at 12:40 PM an interview was conducted with the facility’s Medical Director. He confirmed if the facility could not provide care to meet the patient’s needs, as in the case of a patient that tested positive for colonization of C. Auris, the patient would be involuntarily discharged. He stated this is not a facility policy but rather a decision made at the corporate level. Interview with the DO on 1/16/2024 at 12:30 PM stated the facility does not have a policy for the care and treatment of patients with C. Auris. The Department of Health Infection Prevention Lead, on 1/26/2024 at 1:00 PM, confirmed patients that test positive for colonization of C. Auris should be treated with contact precautions. Interview with an RN (Registered Nurse) on 1/16/2024 at 9:30 AM confirmed that they have treated patients that required contact precautions in the past. Interview with the Director of Clinical Services/Infection Prevention and Senior Director of Regulatory Affairs was conducted on 1/16/2024 at 1:52 PM. It was confirmed during interview that patients colonized with C. Auris would not be treated at the facility. The patients would be involuntarily discharged. It was confirmed the patients would be provided a 30-day notice but would not be treated at the facility during those 30 days. They stated they are looking at the involuntary discharge policy to determine if the policy is written correctly. There was no infection control policy specific to C. Auris (only MRSA and VRE). The patients (#2,3,4) were in the hospital. Once they were ready for discharge the dialysis facility refused to take them back for treatment so they remained in the hospital while the hospital found an alternative dialysis facility that would treat them. A Network 7 was representative was interviewed on 1/16 at 2:30 PM. The facility believes they have solved the problem by opening a C. Auris POD at a sister facility and will internally transfer the patient there. If the patient does not want to transfer, then the facility would have to implement the IVD. The part of the IVD process the facility did not provide was the 30-day notice. Review of the facility policy, “Routine and Involuntary Patient Discharge Procedure,” states the facility will follow the steps, in the following order, when considering non-immediate or immediate involuntary discharge: 1. notify the Director of Operations, 2. contact Corporate Clinical Services for review, 3. notify and obtain written order from the Medical Director and attending physician for discharge, 4. once previous steps are completed, prepare a 30-day notice of discharge (Patient Discharge Letter) to provide to the patient outlining why the patient’s medical needs can no longer be met by the facility, 5. provide the patient and his/her representative with a list of alternative treatment facilities in the area, assist with transferring care of the patient to another facility, and document this in the medical record, 6. notify the ESRD Network and State agency of the intended discharge the same day the letter is provided to the patient.”