Davita Riverwood Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 27408 Based on observation, interview, and record review, the facility failed to maintain a sanitary environment to minimize the transmission of infectious agents which could result in an increased potential for infection for all 57 in-center patients currently being treated by the facility. Findings include: The facility failed to ensure all staff members wear required Personal Protective Equipment (PPE). (See Tag V-0115) The facility failed to ensure that staff separated clean supplies from contaminated areas. (See Tag V-0117) The facility failed to disinfect dialysis stations after treatments. (See Tag V-0122) The facility failed to properly label syringes with intravenous (IV) medications for patient use. (See Tag V-143).”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 27408 Based on observation, interview and policy review, the facility failed to ensure that all staff wear Personal Protective Equipment (PPE) per guidelines in the treatment area, resulting in the potential to spread infectious agents among the 9 patients receiving dialysis treatment at the time of observation. Findings include: On 04/02/25 at 1000, Staff I was observed at station #2, pulling off contaminated bloodlines from the machine, with no PPE on (gown & shield). On 04/02/25 at 1003, an interview with Staff I revealed that he was “just walking off the floor. I did have it on, but I should’ve had it on taking care of the patients”. On 04/02/25 at 1000, Staff J was observed at station #10, touching the patient’s contaminated bloodlines, with no PPE on (gown or shield). On 04/02/25 at 1010, an interview with Staff J revealed that she “knew better” and “should’ve had it on”. On 04/02/25 at 1005, the Charge Nurse, Staff M, was queried regarding staff at the treatment stations with no PPE on, Staff M stated, “they should always have it on while treating patients.” On 04/02/25 at 1300, review of policy “Infection Control for Dialysis Facilities”, policy: 1-05-01 dated/revised 4/2023 on page 2 stated under “PPE (i.e. gown, gloves, eye protection, face shield), 5. Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient care areas”.”

“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: 15195 Based on observation, interview, and record review, the facility failed to take measures to prevent cross contamination when passing medications to ten incenter patients, resulting in the potential for spread of infectious organisms. Findings include: On 4/1/25 at approximately 1025, Staff Nurse L was observed near station 16 with a rolling cart containing medications in syringes, oral medications in cups, and an ice water container and started to pass medications to patients. On 4/1/25 at approximately 1026, the Clinical Coordinator (Staff C) entered the unit and motioned to Nurse L to stop. Interview with Clinical Coordinator C at that time revealed that it was not the best practice for Nurse L to pass medications on the dialysis unit on a common medication cart. Review of the facility policy titled “Infection Control For Dialysis Facilities, # 1-05-01, dated April 2023” documented, “Measures will be taken to prevent cross contamination between patients...” Review of facility procedure titled “Preparation and Administration of Parenteral Medications (Non-ESA, Non Parsabiv), #1-06-01A, dated April 2024” documented, “Rolling medication carts must not be used to dispense or administer medications.””

“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: 47415 Based on observation, interview and record review, the facility failed to ensure that 3 dialysis stations (# 5, #6, #14) were disinfected between patients according to standards of practice and facility policy, resulting in the potential transmission of infectious agents to the 10 patients currently receiving dialysis at the facility. Findings include: On 4/02/25 at 0900, Patient Care Technician (PCT), Staff N was observed disinfecting station #5. Staff N did not lower the right-side table to disinfect all chair surfaces, did not empty and clean the prime bucket, and did not clean back ledge. On 4/2/25 at 0905, during an interview with Staff N, she revealed that she should have cleaned all surfaces of the chair, emptied and cleaned the prime bucket and the back ledge, and that she usually does. On 4/2/25 at 0945, Patient Care Technician (PCT), Staff I was observed disinfecting station #6. Staff I did not empty or clean the prime bucket or disinfect the back ledge. On 4/2/25 at 0950 an interview with Staff I revealed that the prime bucket should be emptied and cleaned before the next patient arrives, and the back ledge had nothing stored on it, so it was not cleaned. On 4/3/25 review of policy 1-05-01 “Infection Control for Dialysis Facilities” revealed, “At the end of each treatment, the dialysis station will be cleaned and disinfected ...Surfaces to disinfect include ... all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front and sides of dialysis machine; touchscreens; countertops) ...Priming containers are to be emptied prior to disinfection ...”. On 4/3/25 at approximately 1030, an interview with Medical Director Staff E revealed it is his expectation that staff follow the policies and procedures of the facility. 27408 On 04/03/25 at 1015, observation of Patient Care Technician (PCT), Staff O, was disinfecting station #14. Staff O did not disinfect the back shelf of the station and did not disinfect the chair’s footrest. On 04/03/25 at 1017, during an interview with Staff O, she revealed that she had forgot to disinfect those areas at each station. Staff O stated she “was a little nervous, but I usually do (clean) them”.”

“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: 15195 Based on observation, interview, and record review, the facility failed to ensure that medications that are open and available for use were not outside their safe use timeframe, resulting in the potential for transmission of infectious agents for all 57 patients who were treated at the facility. Findings include: On 4/1/25 at approximately 1030, seven Venofer (iron) medication in syringes were observed without the time they were drawn up or expiration times. On 4/1/25 at approximately 1030, interview with Staff Nurse L revealed that she drew up the medications earlier this morning, exact time unknown. Review of the facility policy titled “Preparation and Administration of parenteral Medications (Non-ESA, Non-Parsabiv), #1-06-01A, dated April 2024” documented, “Label the syringe with... the date, time, and initials of licensed teammate preparing the dose...” The dates and/or times were not documented. On 4/1/25 at 1105, Staff Nurse M was observed drawing up Epogen (ESA) from a multi-dose vial. The vial was dated with the opened date and time, but not an expiration date (after opening). On 4/1/25 at 1105, when queried about the expiration date of the Epogen multi-dose vial, Nurse M stated “in 30 days.” Review of the facility policy titled “Preparation and Administration of Intravenous Vial-Supplied ESA, #1-06-04A, dated April 2024” documented, “ESA in multi-dose vials may be kept for up to 21 days after opening before they must be discarded...” On 4/3/25 at approximately 0900, a 30 milliliter multi-dose vial of Heparin was noted on the counter (across from station #8) to be opened and undated to determine the expiration date. On 4/3/25 at approximately 0910, Tech I was queried about the vial and he immediately dated and timed the vial with the date opened and expiration date. On 4/3/25 at approximately 0915, interview with Clinical Coordinator C revealed that the best practice was to date and time when the vial was opened and the expiration date.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 22050 Based on observation, interview, and record review, the facility failed to clean, maintain and secure the physical plant, resulting in the increased potential for the spread of infectious agents amongst all patients served by the facility. Findings include: On 4/1/25 at 11:35 A.M., 1 of 2 overhead light assemblies were observed non-functional, within the Clean Supply Storage Room. BioMed “D” indicated he would contact the maintenance service contractual vendor for necessary repairs as soon as possible. On 4/1/25 at 11:40 A.M., The flooring surface was observed stained/soiled with accumulated and encrusted dust/dirt deposits, within the Ancillary Equipment Storage Room. The room was also observed in disarray. BioMed “D” indicated he would contact the housekeeping service contractual vendor as soon as possible. On 4/1/25 at 11:45 A.M., The flooring surface was observed soiled with accumulated and encrusted dust/dirt deposits, within the Hazardous Waste Storage Room. The room was also observed in disarray. BioMed “D” indicated he would contact the housekeeping service contractual vendor as soon as possible. On 4/1/25 at 11:55 A.M., The Receiving Corridor entrance doors lower surface was observed corroded and missing, creating a gap between the metal threshold plate and door bottom. The gap measured approximately 0.25 - 0.50 inches-wide by 36-inches-long. On 4/1/25 at 12:00 P.M., The Janitorial Closet flooring surface was observed stained and soiled with accumulated and encrusted dust/dirt deposits. The housekeeping cart was also observed soiled with accumulated and encrusted dust/dirt/grime deposits. On 4/1/25 at 01:10 P.M., An environmental flash tour was conducted with BioMed “D”. The following items were noted: The metallic entrance door frame to the storage room was observed soiled with accumulated and encrusted dust/dirt deposits. BioMed “D” indicated he would contact the housekeeping service contractual vendor as soon as possible. Sixteen of sixteen connection chase boxes were observed soiled with accumulated and encrusted dust/dirt/debris deposits. BioMed “D” indicated he would contact the housekeeping service contractual vendor as soon as possible. Nine of nine computer keyboards and monitors were observed soiled with accumulated and encrusted dust/dirt/grime deposits. BioMed “D” indicated he would contact the housekeeping service contractual vendor as soon as possible. On 4/1/25 at 01:56 P.M., An interview was conducted with BioMed “D” regarding the facility maintenance service agreements. BioMed “D” stated: “We have (Vendor Name) for maintenance services.” On 4/1/25 at 02:05 P.M., An interview was conducted with Facility Administrator (FA) “B” regarding the facility housekeeping agreement. (FA) “B” stated: “We have (Vendor Name) Cleaning Services.” On 4/3/25 at 09:30 A.M., Record review of the “(Vendor Name) Cleaning Services” agreement dated 12/05/2021 revealed under I. Services: “(C) Monthly: (7) Clean interior/exterior doors paying close attention to door jambs.” On 4/3/25 at 09:45 A.M., Record review of the “(Vendor Name)” maintenance service agreement dated 1/01/2025 revealed the following services must be provided per regulatory oversight: (1) Implement a program to ensure that equipment is maintained in accordance with manufacturer recommendations; (2) Maintain its building to provide patients, staff, and the public a safe, functional and comfortable environment; (3) Provide and monitor a sanitary environment; (4) Implement a program to ensure that equipment is maintained in accordance with manufacturer recommendations; and (5) Comply with the Life Safety Code of the National Fire Protection Association.” 27408 On 04/02/25 at 1010, during the initial entrance tour, this surveyor walked on to the treatment floor, through the open/unsecured door between the lobby and into the treatment room. The survey team was identified, and Charge Nurse, Staff M, was queried regarding the treatment room door being open to which Staff M stated, “We have it open, so we know when patients come in, since we don’t have an AA (Administrative Assistant) here.” There were 2 patients/visitors walking in behind this surveyor, 3 patients/visitors in the lobby and no one in the administrative front desk area. On 04/02/25 at 1003, Staff M was queried regarding the propped treatment room door. Staff M stated, “No the door should never be open for anyone to just walk in.” On 04/02/25 at 1340, during review of Policy: 8-04-01 original date 9/2008 last revision date 04/2018, Titled “Physical Environment” page 2 of 2, #9) revealed “Systems to assure patient safety will be in place ... Access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only”.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 15195 Based on record review, and interview the facility failed to reassess unstable patients monthly for 1 (#6) of 2 unstable patients reviewed, resulting in the potential for less than optimal outcomes. Findings include: On 4/2/25 at approximately 1100, medical record review revealed that patient #6 was determined to be unstable on 1/20/25 and 2/27/25. The reason was not documented on the Plan of Care summaries. Further medical record review revealed that the patient had very low hemoglobins (red blood cells that carry oxygen to the body) ranging from 5.4 g/dL (grams per deciliter) to 5.9 g/dL. Interview with the Facility Administrator (Staff B), on 4/2/25 at approximately 1300, revealed that the patient had sickle cell disease and she remained unstable. A request for the March 2025 unstable Interdisciplinary Plan of Care documentation revealed that it had not been done. Review of the facility policy titled “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, #1-14-01, dated October 2024” documented, “...Monthly (unstable patients)- Monthly until patient is determined by interdisciplinary team to be stable...””

“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: 47415 Based on observation, interview and record review, the Medical Director failed to ensure that: staff followed physician orders for the prescribed dialysis flow rate for 1 (P-5) of 4 prescriptions checked on the treatment floor during their dialysis session; staff failed to complete an initial nursing assessment, according to facility policy, prior to their first treatment at the facility for 1 (P-7) of 1 new patient records reviewed; and staff failed to follow policy and document actions taken to address elevated blood pressures in 2 (P- 5, P-6) of 7 patient treatment records reviewed; resulting in the potential for poor outcomes for the patients. Findings include: On 4/2/25 at 0855, dialysis treatment orders were checked with registered nurse, Staff P, for the patient who was receiving dialysis treatment at station #5 (P-5). Provider’s order prescribed a DFR (dialysate flow rate) at 800 milliliters (mL)/minute. Dialysis machine had DFR running at 600 mL/minute during the current treatment session that began at 0543. Staff P was asked why DFR flow rate was set to 600 and she stated it should have been set at 800. Record review revealed there was no documentation explaining the change in dialysate rate for this patient. Record review of policy and procedure #12-03-06A, titled “Prescription Verification and Safety Check Procedure for Conventional Dialysis Delivery” revealed, “Verify and document prescribed, dialyzer, dialysate ...dialysate flow ...Patient prescription is verified prior to initiation of treatment”. On 4/2/25 at 1330, record review revealed P-7 a 75-year-old male was admitted to the facility with end stage renal disease and diabetes mellitus, for continued dialysis care. During record review, the initial nursing assessment was requested. On 4/2/25 at 1510 during interview, Regional Director Staff H stated that no initial nursing assessment could be found in the medical record prior to the first hemodialysis treatment at the facility, it was not done. Record review of Policy 01-03-07, titled, “Initial Patient Nursing Assessment for New Patients”, dated April 24 revealed, “A registered nurse (RN) as required by federal regulation will perform an initial pretreatment evaluation of all patients prior to the initiation of their first treatment at the facility”. On 4/3/25 at 1500, review of the medical record for P-5 revealed that on 3/25/25 treatment sheet blood pressure (BP) recorded: at 1045 was 165/112, at 1145: 171/112, and at 1154: 169/116. Review of narrative notes documented with BP entries revealed no entries of notification of elevated BPs to a registered nurse (RN), or to the physician. Review of P-5’s treatment sheet dated 3/27/25 revealed blood pressure recorded: at 0817 was 139/109, at 0827: 164/115, at 0846 160/104, at 0916: 166/117, at 0918, 159/112, at 0946 157/112, at 1019: 165/107, at 1046: 161/107, at 1146: 163/110, and at 1201 171/112. Review of narrative notes documented with BP entries revealed an entry by patient care technician (PCT) of notification to the RN of elevated BP at 0916, no notification to the physician documented. Review physician’s orders revealed P-5 had an order for Clonidine 0.1 milligrams (mg) every 4 hours as needed, order date “5/30/24 - No End Date”. Clonidine was not administered for elevated BP on 3/25/25 or 3/2725, review of record revealed no documentation of why the medication was not administered. On 4/3/25 at approximately 1000, interview with Staff C revealed, that she calls the physician to report changes in patient condition including blood pressures, and that she knows P-5 and how she reacts to clonidine and that it is not always given (sometimes based on if patient has taken own BP medication at home). Staff C confirmed there was no documentation of why the “as needed” medication for elevated blood pressure was not given to P-5 on 3/25/25 or 3/27/25, and that the RN did not document physician was notified of elevated BP. On 4/3/25 at approximately 1030, an interview with Medical Director Staff E revealed it is his expectation that staff follow the policies and procedures of the facility. On 4/3/25, review of policy 1-03-08, titled “Pre-Intra-Post Treatment Data, Collection, Monitoring and Nursing Assessment” dated April 24 revealed: Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ...The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary ...Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time ... Blood Pressure-Intradialytic: o Systolic greater than 180 mm/Hg or less than 90 mm/Hg o Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg”. 15195 Additionally, review of P-6’s medical record revealed that she was a 35-year-old female with end stage renal disease and sickle cell disease who began treatment as the facility on 11/22/24. On 3/27/25 at 0946 the patient began her dialysis treatment with a blood pressure of 195/125 without a note which documented that the nurse had been notified. The treatment sheet lacked a note by the nurse addressing the high blood pressure or about the physician being aware or notified. The patient continued her dialysis treatment until 1135 when treatment was ended and her blood pressure was high at 186/119. No anti-hypertensive medication was given during treatment. The patient had an order for Clonidine 0.1 milligrams oral as needed to be given for high blood pressure which was not given. Again, there was no note by the nurse addressing the elevated blood pressures or about the physician being notified. Interview with the Clinical Coordinator (Staff C), On 4/3/25 at approximately 1015, verified lack of documentation and verified that the Clonidine had not been given.”