Fmc - Noblesville Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 42617 Based on observation, grievance log review, policy review, and interview, the dialysis facility failed to ensure bleach solution containers were labeled with the date and time the solution was made, failed to ensure all visitors on the ICHD treatment floor wore appropriate personal protective equipment (PPE), and failed to ensure all reusable equipment was cleaned after patient use (see V111); failed to ensure staff and patients followed facility infection control policies and procedures (see V113), failed to ensure staff were not chewing gum while on the treatment floor (see V115); failed to ensure all staff disinfected the dialysis station according to infection control policies and best practice (see V122), failed to complete re-education on hand hygiene and PPE use after patient and staff reports of non-compliance (see V132); and failed to ensure staff performed infection control measures according to policy when caring for a CVC (see V147). Due to the cumulative effects of these systemic issues, Fresenius Medical Care Noblesville failed to provide adequate infection control measures and was found out of compliance with Condition of Coverage 42 CFR 494.30 Infection control.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure bleach solution containers were labeled with the date and time the solution was made, failed to ensure all visitors on the ICHD treatment floor wore appropriate personal protective equipment (PPE), and failed to ensure all reusable equipment was cleaned after patient use for 1 of 1 day of ICHD observations, which had the potential to affect 47 active ICHD patients. Findings include: 1. The facility policy “Mixing Bleach,” dated 2/03/2025, indicated staff would label bleach solution containers with the “date and time prepared, and preparer’s initials ....” 2. The facility policy “General Cleanliness and Infection Control Guidelines,” dated 9/02/2025, indicated “noncritical medical equipment ... must be disinfected with 1:100 bleach or an EPA registered disinfectant ....” 3. The facility policy “Visitor Policy,” dated 10/30/2025, indicated no visitors were permitted “during the initiation and discontinuation of dialysis unless they are assisting with patient care ... PPE will be provided along with instructions for proper use if there is a likelihood that the visitor may be exposed to bloodborne pathogens during the time that he/she is in the treatment area ....” 4. During an ICHD treatment floor observation on 10/31/2025 beginning at 8:57 AM, three containers of bleach solution were observed on a cart next to the nurse’s station. The containers failed to evidence the date and time the solution was prepared nor the preparer’s signature. During an interview on 10/31/2025 beginning at 9:32 AM, PCT 1 reported she had prepared the bleach solution that morning. PCT 1 stated she should have labeled the solution containers with the date and time it was prepared. 5. During an ICHD treatment floor observation in Station 8 on 10/31/2025 beginning at 11:07 AM, PCT 3 was terminating Patient #11’s dialysis and de-cannulating Patient’s arteriovenous (AV) fistula. Person A, Patient’s caregiver, was observed standing in Station 8 during termination and decannulation procedures. The facility failed to ensure Person A was wearing PPE while in Station 8 to reduce the risk of exposure to bloodborne pathogens. During an interview on 11/04/2025 beginning at 1:54 PM, PCT 3 reported any visitors on the treatment floor should wear a gown and face shield. During an interview on 11/04/2025 beginning at 2:30 PM, RN 1 reported Person A should not be on the treatment floor during cannulation or de-cannulation procedures with Patient #11. 6. During an ICHD treatment floor observation on 10/31/2025 beginning at 11:17 AM, Person A was observed transferring Patient #11 from Station 8 to the floor scale via wheelchair. After assisting Patient onto the scale, Person A obtained Patient’s temperature with an infrared thermometer sitting on a nearby shelf. RN 1 stood next to Person A and Patient and documented Patient’s weight and temperature. RN 1 failed to clean the thermometer after Person A’s use. 7. During an ICHD treatment floor observation on 10/31/2025 beginning at 11:52 AM, Patient #3 was observed walking from Station 5 to the floor scale with RN 1. Patient obtained their temperature with the same infrared thermometer used by Person A. RN 1 stood next to Patient while they obtained their temperature. RN 1 failed to clean the thermometer after Patient use. During an interview on 11/04/2025 beginning at 2:30 PM, RN 1 reported the reusable thermometer located next to the scale should be cleaned with an alcohol wipe in between patient use.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff and patients followed facility infection control policies and procedures for 3 of 3 PCTs observed performing procedures on the ICHD treatment floor (PCT 1, PCT 2, PCT 3) and 1 of 2 observations of an arteriovenous (AV) fistula discontinuation (Patient #7). Findings include: 1. The facility policy “Hand Hygiene”, dated 11/06/2023, indicated staff should perform hand hygiene “before and after direct contact with patients ... before performing any invasive procedure such as vascular access cannulation ... Immediately after removing gloves ... After contact with other objects within the patient station or treatment space.” The policy also indicated patients should perform hand hygiene after each dialysis treatment “to help ensure the prevention of cross contamination to [patients’] family members or other patients. Gloves were to be provided to patients “when performing procedures which risk exposure to blood or body fluids, such as ... holding [fistula or graft] access sites post treatment ....” 2. During an observation at Station 11 on 10/31/2025 beginning at 9:41 AM, Patient #7 was observed holding pressure to two decannulated AV fistula sites. After the sites stopped bleeding, PCT 1 taped gauze to the site and assisted Patient in removing their glove. Patient left the treatment floor without performing hand hygiene. PCT 1 failed to instruct Patient to perform hand hygiene after removing their glove. During an interview on 11/03/2025 beginning at 1:33 PM, PCT 1 reported patients should wash their hands or use hand sanitizer after holding pressure to fistula cannulation sites. PCT 1 stated on 10/31/2025 she did not observe Patient performing hand hygiene after removing their glove and leaving the station. 3. During an observation at Station 12 on 10/31/2025 beginning at 10:19 AM, PCT 1 was observed performing cannulation procedures to Patient #10’s fistula. After assessing the fistula, PCT 1 left the station, obtained a tourniquet from a supply drawer, then returned to Station 12. PCT 1 failed to perform hand hygiene when leaving Station 12. During an interview on 11/03/2025 beginning at 1:33 PM, PCT 1 reported she should perform hand hygiene when leaving a patient station. 4. During an observation at Station 10 on 10/31/2025 beginning at 10:50 AM, PCT 2 entered the station and donned gloves, failing to perform hand hygiene prior to donning gloves. During an interview on 11/03/2025 beginning at 1:48 PM, PCT 2 reported she should perform hand hygiene prior to donning gloves. 5. During an observation on the ICDH treatment floor on 10/31/2025 beginning at 12:33 PM, PCT 3 was observed leaving Station 7 and removing her gloves. PCT 7 went to a medication preparation station, gathered pre-drawn medication syringes and supplies, entered Station 5, donned gloves, and began to perform CVC site care to Patient #12. After removing the old dressing and cleaning the CVC site, PCT 3 donned new gloves. PCT 3 failed to perform hand hygiene after removing gloves two times and failed to perform hand hygiene between glove changes one time during the observation. During an interview on 11/04/2025 beginning at 1:54 PM, PCT 3 reported she should perform hand hygiene before donning and after removing gloves. 44714 6. During an observation at Station 7 on 10/31/2025 beginning at 10:05 AM, PCT 3 discontinued dialysis with Patient #2’s CVC. PCT 3 failed to use alcohol-based hand sanitizer between glove changes four times during the process. 7. During an observation at Station 7 on 10/31/2025 at 10:15 AM, PCT 3 discontinued dialysis for Patient #2’s fistula. PCT 3 failed to complete hand hygiene between glove changes three times during the process. 8. During an observation at Station 7 on 10/31/2025 at 10:25 AM, PCT 3 failed to complete hand hygiene twice while they disinfected the station.”

“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: 44714 Based on observation, record review and interview, the dialysis facility failed to ensure staff were not chewing gum while on the treatment floor, for 1 of 3 PCTs observed on the ICHD treatment floor (PCT 1). Findings include: 1. The agency policy “General Cleanliness and Infection Control Guidelines,” dated 9/02/2025, indicated eating and drinking are not allowed on the treatment floor. 2. During an observation on the treatment floor on 10/31/2025 beginning at 08:55 AM, PCT 1 was observed chewing gum while on the treatment floor. 3. During an interview on 11/04/2025 beginning at 01:15 PM, PCT 1 indicated they should not chew gum while on the treatment floor. 4. During an interview on 11/04/2025 beginning at 03:26 PM, the CM indicated staff were not to have food, drinks, or chewing gum while on the treatment floor.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure all staff disinfected the dialysis station according to infection control policies and best practice in 3 of 3 observations of staff disinfecting a dialysis station (PCT 1, PCT 2, PCT 3). Findings include: 1. A facility policy “Cleaning and Disinfecting the Dialysis Station,” dated 9/02/2025, indicated “in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients ....” The dialysis station was defined as the “area including dialysis machine, chair/bed and other reusable equipment ....” When cleaning the station, staff were to “clean all surfaces. Make the surfaces glisteningly wet and allow to air dry.” 2. During an ICHD treatment floor observation on 10/31/2025 beginning at 9:37 AM, PCT 1 was observed cleaning Station 12 in between patient use. After wiping the chair and arm rest pillow with 1:100 bleach solution, PCT 1 immediately closed the chair’s side panels, returned the arm rest pillow to a supply area, and placed new supplies on the chair, failing to allow the bleach solution to dry. During an interview on 11/03/2025 beginning at 1:33 PM, PCT 1 reported she would not wait to shut the chair’s side panels after wiping them with bleach solution, as they were not wet but “moist.” The technician stated she should wait for arm rest pillows to dry prior to returning to the storage shelf and should also wait for the station surfaces to be dry prior to bringing in new supplies. 3. During an ICHD treatment floor observation on 10/31/2025 beginning at 10:58 AM, PCT 2 was observed cleaning Station 2 in between patient use. After wiping the chair’s side panels with 1:100 bleach solution, PCT 2 immediately closed the side panels, failing to allow the bleach solution to dry. During an interview on 11/03/2025 beginning at 1:48 AM, PCT 2 reported she was “not supposed to” close a chair’s side panels prior to the bleach solution drying. 44714 4. During an ICHD treatment floor observation on 10/31/2025 at 10:25 AM, PCT 3 disinfected the vacant chair at Station 7. PCT 3 cleaned the chair with 1:100 bleach solution, including the chair’s side panels. PCT 3 closed the side panels immediately after wiping them with disinfectant. PCT 3 failed to allow the chair sides to dry prior to closing them. During an interview on 11/04/2025 beginning at 01:54 PM, PCT 3 indicated they closed the chair sides immediately after cleaning.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 42617 Based on grievance log review and interview, the dialysis facility failed to complete re-education on hand hygiene and personal protective equipment (PPE) use after patient and staff reports of non-compliance during ICHD dialysis treatment for 1 of 2 patient grievance reported in September 2025 regarding staff infection control practices (Patient #1). Findings include: 1. The facility ’ s “Patient Grievance” policy, dated 5/05/2025, indicated the CM and/or Facility Administrator should investigate all patient grievances. A grievance could be “closed” on the log when “Resolution is reached ...” 2. The facility’s complaint log from 10/31/2024 - 10/31/2025 included a grievance, dated 9/19/2025 and reported by Patient #1, which indicated Patient reported PCT 1 did not change her gloves between caring for multiple patients. PCT 1 also reportedly “touched another patient’s lines without changing gloves.” MSW 1 documented she had also observed the “same issues” with PCT 1. CM documented he would “have a 1:1 conversation with [PCT 1] and a team huddle with all staff. I will have everyone sign the infection control policy ....” The facility staff noted the grievance was “resolved” on 10/29/2025. 3. During an interview on 10/31/2025 beginning at 11:58 AM, Patient #1 reported PCT 1 “never” performed hand hygiene while on the ICHD treatment floor. Patient had observed the technician frequently go between multiple patients and stations with the same gloves on. Patient reported staff were “putting on a show” for the state agency surveyors as they did not routinely change gloves or perform hand hygiene between patients or tasks. 4. During an interview on 10/31/2025 beginning at 3:28 PM, RN 1 reported she had observed staff failing to change gloves between patients and stations. 5. During an interview on 11/03/2025 beginning at 2:35 PM, CM reported he had not yet performed all interventions identified in the grievance documentation. CM stated the grievance should not have been marked as “resolved.” 6. During an interview on 11/04/2025 beginning at 1:54 PM, PCT 3 reported the facility had not conducted any re-education or training regarding infection control and/or hand hygiene procedures.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure staff performed infection control measures when caring for a CVC for 2 of 2 observations of disconnection from dialysis with a CVC (Patient #2, #8) Findings include: 1. The facility policy “5008X Termination of Treatment Using a Central Venous Catheter ...,” dated 6/26/2025, indicated prior to disconnecting a patient’s CVC from dialysis, staff should “ensure that a clean under pad is below the catheter limbs ....” When disconnecting the CVC from the dialysis blood lines, staff should scrub the CVC hub “thoroughly with friction” for “10-15 seconds.” 2. During an observation at Station 2 on 10/31/2025 beginning at 9:46 AM, PCT 2 discontinued Patient #8’s dialysis from their CVC. When disconnecting the blood lines, PCT 2 scrubbed the hub of 1 of the 2 CVC ports for two seconds. During an interview on 11/03/2025 beginning at 1:48 PM, PCT 2 reported she should scrub the hub of a CVC for “15 seconds.” 44714 3. During an observation at Station 7 on 10/31/2025 beginning at 10:05 AM, PCT 3 discontinued Patient #2’s dialysis from their CVC. PCT 3 failed to place a clean barrier under the CVC lines to reduce the risk of infection. During an interview on 11/4/2025 beginning at 01:54 PM, PCT 3 indicate they were unaware of the need to use a clean barrier prior to working with the CVC.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 42617 Based on adverse event report review, policy review, and interview, the facility failed to ensure staff documented all adverse events according to facility policy for 1 of 1 ICHD patient record reviewed which evidenced adverse events (Patient #2). Findings include: 1. The facility policy “Patient Safety Event Reporting and Documentation,” dated 9/02/2025, indicated staff were to report and document adverse events including but not limited to a “damaged [hemodialysis] catheter that required repair or replacement ... Hemodialysis Access - Infiltration.” 2.Patient #2’s clinical record evidenced Patient had a CVC and an AV fistula, both of which were being used for ICHD treatment. During an interview on 11/03/2025 beginning at 1:48 PM, PCT 2 reported on 10/24/2025, Patient had a fistula venous access infiltration during treatment. Patient was using only their fistula for dialysis at the time, so PCT 2 connected Patient to the venous port of their CVC to continue treatment. While performing CVC site care prior to initiating treatment, a clamp on the arterial CVC lumen broke off. PCT 2 reported Patient left their ICHD treatment with two hemostats used as a temporary arterial CVC clamp. During an interview on 11/03/2025 beginning at 3:47 PM, RN 2 reported the clamps on Patient’s arterial CVC lumen had broken during the 10/24/2025 treatment. RN 2 stated she did not document this as an adverse event and was unsure if it was documented in Patient’s clinical record. During an interview on 10/31/2025 beginning at 3:28 PM, RN 1 reported Patient had to have their CVC exchanged by a local hospital on 10/27/2025 due to the arterial CVC clamp breaking off. Patient’s clinical record included dialysis flowsheets dated 10/20/2025 - 10/31/2025. The flowsheet dated 10/24/2025 failed to evidence staff documented Patient’s fistula infiltration nor the broken clamp on the CVC. The flowsheet dated 10/27/2025, Patient’s next treatment after 10/24/2025, indicated Patient’s “CVC arterial clamp remains broken ....” Two flowsheets dated 10/28/2025 and 10/29/2025 indicated Patient had “Skin Discoloration/Redness/Bruising ...” to their fistula site. 3. Review of the facility’s adverse events reported between 10/31/2024 - 10/31/2025 failed to evidence staff documented Patient #2’s 10/24/2025 damaged CVC nor the fistula infiltration.”

“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: 42617 Based on observation, record review, policy review, and interview, the medical director failed to ensure staff followed policies specific to fistula access site disinfection for 1 of 2 observations of ICHD fistula cannulation (Patient #13), monitoring and reporting of abnormal vital signs for 4 of 5 ICHD records reviewed (Patient #2, #3, #4, #5), and verification of correct dialysis prescription for 2 of 5 ICHD records reviewed (Patient #2, #4) and 2 of 2 observations of ICHD prescription verification for patients with an Optiflux F160NR dialyzer ordered (Patient #1, #2) Findings include: 1. The facility policy “Access Assessment and Cannulation,” dated 5/05/2025, indicated if a patient was unable to wash their access site prior to treatment, staff should wash the access site with soap and water. When disinfecting cannulation sites, staff should scrub each site with a 70% alcohol pad for “30 seconds” prior to cannulation. 2. The facility policy “Nursing Supervision and Delegation”, dated 11/06/2023, indicated the RN must evaluate each patient within an hour of treatment initiation to “review accuracy and completeness of treatment and patient data ... Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed.” PCTs were to report the following vital signs to the nurse for further assessment: a. A systolic (SBP, top number in a BP reading) value greater than 180 millimeters of mercury (mmHg) at any time before, during, or after treatment b. A diastolic (DBP, bottom number in a BP reading) value greater than 100 mmHg at any time before, during, or after treatment c. A drop in SBP of 20 mmHg between sitting and standing 3. The facility policy “Patient Assessment and Monitoring,” dated 6/26/2025, indicated during treatment, staff were to report a heart rate (HR) less than 60 or greater than 100 to the RN. The policy also indicated a patient’s BP and HR were to be obtained “every 30 minutes or more as needed but not to exceed 45 minutes.” 4. A review of a medical journal article (available at https://pmc.ncbi.nlm.nih.gov/ articles/PMC4459970/ pdf/pone.0122248.pdf) indicated a normal SBP reading taken at the ankle was 110-170 mmHg. 5. During an observation at Station 4 on 10/31/2025 beginning at 12:56 PM, PCT 2 was preparing to initiate dialysis through Patient #13’s arteriovenous (AV) fistula. Patient did not wash their fistula site upon entering the treatment floor, nor did PCT 2 clean the fistula site with soap and water prior to disinfecting. PCT 2 disinfected the two cannulation sites with a 70% alcohol wipe for 10 seconds each. During an interview on 11/03/2025 beginning at 1:48 PM, PCT 2 reported Patient did not clean their fistula site upon entering the treatment floor due to being visually impaired. PCT 2 reported she did not clean patients’ fistula or graft sites prior to disinfection and cannulation. The technician stated each cannulation site should be scrubbed with alcohol for 30 seconds. 6. Patient #2’s clinical record included a special attention order indicating Patient may dialyze with “asymptomatic hypertension” (high blood pressure). The record included seven treatment flowsheets between 10/20/2025 - 10/31/2025. The flowsheets evidenced the following: a. On 10/20/2025, Patient had four SBPs between 181-196 mmHg and two DBPs between 104-111 mmHg during treatment. The record failed to evidence the PCTs notified the RN of the elevated BPs nor was Patient assessed for symptoms of high blood pressure. b. On 10/22/2025, Patient had four SBPs between 183-189 mmHg and two DBPs between 102-105 mmHg during treatment. The record failed to evidence the PCTs notified the RN of the elevated BPs nor was Patient assessed for symptoms of high blood pressure. Patient’s ordered Dialysate Flow Rate (DFR) was 700 milliliters per minute (ml/min). The flowsheet indicated Patient’s DFR during treatment was 400 ml/min. The record failed to evidence the reason the DFR was not run at the ordered rate. c. On 10/24/2025, Patient had four SBP between 182-200 mmHg and three DBPs between 106-167 mmHg during treatment. The record failed to evidence the PCTs notified the RN of the elevated BPs nor was Patient assessed for symptoms of high blood pressure. The flowsheet indicated for three hours and 21 minutes of Patient’s treatment, the DFR was run at 600 ml/min. The record failed to evidence the reason the DFR was not run at the ordered rate. d. On 10/27/2025, Patient had five SBPs between 182-214 mmHg and five DBP between 104-109 mmHg during treatment. The record failed to evidence the PCTs notified the RN of the elevated BPs nor was Patient assessed for symptoms of high blood pressure. e. On 10/28/2025, Patient had five SBPs between 187-204 mmHg and three DBPs between 100-111 mmHg during treatment. The record failed to evidence the PCTs notified the RN of the elevated BPs nor was Patient assessed for symptoms of high blood pressure. f. On 10/29/2025, Patient had two SBPs between 183-196 mmHg, three DBPs between 109-118 mmHg, and six HRs between 105-121 during treatment. The record failed to evidence the PCTs notified the RN of the elevated BPs and HR nor was Patient assessed for symptoms of high blood pressure. g. On 10/31/2025, Patient had five SBPs between 183-211 mmHg, three DBPs 101-114 mmHg, and five HRs between 101-126 during treatment. The record failed to evidence the PCTs notified the RN of the elevated BPs and HR nor was Patient assessed for symptoms of high blood pressure. During an interview on 11/03/2025 beginning at 1:48 PM, PCT 2 stated she would report Patient’s blood pressure to the nurse if it was above 175 SBP or above 100 DBP. She would report a heart rate if it was above 100. PCT 2 stated no staff documented reporting abnormal vital signs to the nurse and she was not aware where to document this report. During an interview on 11/03/2025 beginning at 3:47 PM, RN 2 was unsure of the reason Patient’s DFR was not run at the prescribed rate on 10/22/2025 or 10/24/2025. RN 2 reported PCTs should report to the nurse a SBP above 180 mmHg, a DBP above “90-100” mmHg, and a HR above 100 during treatment. During an interview on 11/04/2025 beginning at 2:30 PM, RN 1 stated the PCTs should be reporting Patient’s abnormal BPs and HRs to the nurse according to the facility policy. 7. Patient #4’s clinical record included a special attention order indicating Patient may dialyze with a SBP above 90 mmHg. The record included seven treatment flowsheets between 10/20/2025 - 10/31/2025. The flowsheets evidenced the following: a. On 10/21/2025, the record failed to evidence vital signs were obtained and access checks were performed between 10:08 AM - 10:59 AM, when Patient’s treatment ended. b. On 10/22/2025, Patient’s pre-treatment HR was 83. During treatment, Patient had two HRs below 60. Patient’s post treatment sitting SBP was 128 and standing SBP was 104, a drop by 24 mmHg. The record failed to evidence the PCT notified the nurse of the low HRs during treatment nor orthostatic hypotension post-treatment. c. On 10/24/2025, Patient’s pre-treatment HR was 72. During treatment, Patient had two HRs below 60. Patient’s post-treatment sitting SBP was 150 and post-treatment standing SBP was 100, a drop by 50 mmHg. The record failed to evidence the PCT notified the nurse of the low HR during treatment or orthostatic hypotension post-treatment. d. On 10/27/2025, Patient’s ordered Blood Flow Rate (BFR) was 350 mL/min. Patient’s treatment was run at 400 ml/min. The record failed to evidence the reason Patient’s treatment was not run at the ordered BFR. e. On 10/29/2025, Patient’s pre-treatment HR was 63. During treatment, Patient had two HRs below 60. The record failed to evidence the PCT notified the nurse of the low HRs. f. On 10/31/2025, Patient began treatment at 5:56 AM. At 5:58 AM, Patient’s BP was 132/104. The flowsheet failed to evidence vital signs were obtained and access checks were performed between 5:58 AM - 7:04 AM. At 7:04 AM, Patient’s BP was 90/62. During treatment, Patient also had two SBPs below 90. The record failed to evidence the PCT notified the nurse of the low SBPs. During an ICHD treatment floor observation at Station 3 on 10/31/2025 at 9:49 AM, Patient’s dialysis machine was alarming for a low blood pressure reading of “85/44”. PCT 1 entered the station, silenced the alarm, and left the station. The technician failed to report the low SBP to the RN. During an interview on 11/04/2025 beginning at 1:54 PM, PCT 3 stated vital signs and access checks should be done every 30 minutes, and she would report a HR below 60 to the nurse. PCT 3 stated the notification should be documented in Patient’s record. During an interview on 11/03/2025 beginning at 3:47 PM, RN 2 stated PCTs should report a SBP below 100 mmHG to the nurse. During an interview on 11/04/2025 beginning at 2:30 PM, RN 1 stated the PCTs should be reporting Patient’s abnormal BPs and HRs to the nurse according to the facility policy. PCTs should also report a drop in SBP of 20 mmHg or more from sitting to standing. RN 1 was unsure of the reason Patient’s BFR was not run at the ordered rate on 10/27/2025. 8. Patient #5’s clinical record included five treatment flowsheets between 10/20/2025 - 10/31/2025. The flowsheets evidenced: a. On 10/20/2025, Patient had seven HRs between 50-53 and five SBPs between 184-194 mmHg during treatment. The record failed to evidence the PCT notified the RN of the low HRs and elevated SBPs. b. On 10/22/2025, Patient had six HRs between 48-57 and four SBPs between 181-212 mmHg during treatment. Patient’s post-treatment SBP was 198 mmHg. The record failed to evidence the PCT notified the RN of the low HRs and elevated SBP during treatment nor the elevated BP after treatment. The record also failed to evidence vital signs were obtained and access checks were performed between 9:02 AM - 10:03 AM. c. On 10/24/2025, Patient had nine HRs between 47-56 during treatment. Patient’s post-treatment blood pressure was 190/86 mmHg. The record failed to evidence the PCT notified the RN of the low HRs during treatment nor the elevated BP after treatment. d. On 10/27/2025, Patient had eight HRs between 46-54 during treatment. Patient’s post-treatment blood pressure was 149/104 mmHg. The record failed to evidence the PCT notified the RN of the low HRs during treatment nor the elevated BP after treatment. e. On 10/31/2025, Patient’s pre-treatment HR was 55. During treatment, Patient had three HRs between 45-46. Patient’s post-treatment blood pressure was 198/88. The flowsheet failed to evidence the PCT notified the RN of the low HRs during treatment nor the elevated BP after treatment. The flowsheet also failed to evidence vital signs were obtained and access checks were performed between 10:35 AM - 11:45 AM. During an ICHD treatment floor observation at Station 10 on 10/31/2025 at 9:35 AM, Patient’s dialysis machine was alarming for a low heart rate of 45. PCT 1 entered the station, silenced the alarm, and left the station. The technician failed to report the low HR to the RN During an interview on 11/03/2025 beginning at 1:33 PM, PCT 1 stated she would report a SBP above 200 mmHG to the nurse. If a patient’s SBP was above 180 mmHg but below 200 mmHg, she would recheck the BP but would not notify the nurse. During an interview on 11/04/2025 beginning at 2:30 PM, RN 1 stated the PCTs should be reporting abnormal BPs and HRs for Patient to the nurse according to the facility policy. RN 1 reported vital signs should be obtained and access checks performed every 30 minutes. 9. During an observation at Station 1 on 10/31/2025 beginning at 12:09 PM, RN 1 and PCT 1 were verifying Patient #1’s dialysis prescription. Patient’s ordered dialyzer was an Optiflux F160NR (type of filter used to clean the blood; the size of the filter is prescribed by an advanced practitioner). Patient’s dialysis was currently running through an Optiflux F180NR dialyzer. During an interview at the time of the observation, PCT 1 indicated the facility had run out of Optiflux F160NR dialyzers approximately one week prior, and staff had been using the increased dialyzer sizes for all patients who had Optiflux F160NRs ordered. 44714 10. During an observation at Station 7 on 10/31/2025 at 10:05 AM, PCT 3 was in Patient’s station disconnecting Patient #2’s dialysis. Patient’s dialysis prescription included the use of an Optiflux F160NR dialyzer. Observation of the hemodialysis machine evidenced an Optiflux F180NR dialyzer had been used for Patient’s treatment. During an interview at the time of the observation, PCT 3 indicated they used the F180NR Optiflux dialyzer because the facility was out of the size F160NR dialyzers. PCT 3 indicated the facility was phasing out the Optiflux dialyzers and there were no more Optiflux F160NR dialyzers left. During an interview on 11/04/2025 beginning at 10:38 AM, the Medical Director indicated they were aware the facility had been substituting the Optiflux F180NR dialyzers for the F160NR dialyzers. MD was unsure the reason the order had not been updated to reflect the new dialyzer size to be used. MD reported PCTs should notify the nurse for a SBP above 180 mmHg and a heart rate above 100. During an interview on 11/04/2025 beginning at 03:26 PM, the CM indicated they were clearing out the overstock of F180NR dialyzers before using the new dialyzers. Alternate Administrator reported the order should be updated to reflect the dialyzer being used. 11. Patient #3’s clinical record included a special attention order to take blood pressure readings at Patient’s ankle during dialysis to prevent damage to fistulas in the arms. The record indicated dialysis could be done if Patient #3 had asymptomatic hypertension. The clinical record evidenced 12 treatment days between 10/06/2025 and 10/31/2025. Ten treatment days evidenced 25 systolic ankle readings of 170 -199 mmHg. Ten treatment days evidenced 17 systolic ankle readings over 200 mmHg. The clinical record failed to include documentation the PCT notified the RN of the readings nor was Patient assessed for hypertension. During an interview on 11/04/2025 beginning at 01:54 PM, PCT 3 stated “ ... everyone knows they’re not accurate” regarding the ankle blood pressure readings. When asked, PCT 3 indicated they would know there was a problem with Patient #3’s blood pressure if they “ ... looked like [Patient #3] needed to go to the ER [emergency room].” PCT 3 indicated they would let the RN know if they needed to call 911 for Patient #3. During an interview on 11/04/2025 beginning at 03:26 PM, the CM indicated they expected staff to retake blood pressure and/ or pulse rate if “they didn’t seem right.” When asked, the CM indicated they did not find a way to determine if the ankle reading was low, high, or average.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 44230 Based on observation and interview, the facility failed to ensure adequate monitoring of In-center Hemodialysis treatments in 1 of 1 facility reviewed. Findings Include: 1. During an observation of the treatment floor on 01/13/2025 at 12:42 PM, RN 3 was observed assisting a patient receiving treatment. During this time another patient’s machine began alarming and the phone was began ringing. RN 3 appeared overwhelmed with the tasks that needed to be completed. When asked where the scheduled PCT’s were RN 3 shrugged her shoulders, turned and quickly walked away to attend to the alarming machine and answer the phone. RN 3 was the only staff member on the treatment floor attending to the 10 dialysis patients receiving treatment. 2. During an interview on 01/14/2025 at 11:13 AM, Patient #1 indicated that staff frequently group lunches together leaving the RN on the floor alone to tend to all the patients. He/she indicated having one staff member to care for all of the patients is unsafe. 3. During an interview on 01/13/2025 at 2:00 PM, RN 3 indicated that when surveyor was on the treatment floor earlier today, she was the only staff member taking care of patients. RN 3 indicated she thought PCT 2 was back from lunch, so PCT 3 was sent to start her lunch break. Staff lunches are rotated to ensure patient safety. 4. During an interview on 01/13/2025 at 1:40 AM, PCT 2 indicated the facility is frequently short staffed and cannot always meet the patient’s needs. Fully staffed to him/her is one RN, and 3 PCT’s, however frequently works with just one RN and 2 PCT’s indicating that is not enough. He/she indicated feeling stressed and overworked. PCT 2 indicated that lunches are often rotated and does not know why both PCT’s were off the treatment floor at the same time for lunch. 5. During an interview on 01/13/2025 at 12:45, the Administrative Assistant indicated the RN tends to count her as someone on the floor during lunches even though he/she is not a PCT. At times PCT’s do go to lunch together leaving the RN on the floor alone. The Administrative Assistant indicated that this is a concern that needs to be addressed.”

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 44230 Based on observation, record review, and interview, the facility failed to secure oxygen cylinders in stands and/or racks in 1 of 1 facility reviewed. Findings Include: 1. A policy titled, “Emergency Administration of Oxygen” indicated but was not limited to, “Unless in use, secondary (reverse) cylinders/tanks must be: Secured in racks or rolling stands in a storage area or dedicated area for oxygen”. 2. During an observation on 11/25/2024 at 11:25 AM, the treatment floor evidenced two oxygen cylinders next to the lobby door sitting directly on the floor and not secured in a rack or rolling stand. 3. During an interview on 11/25/2024 at 11:28 AM, RN 6 indicated not being aware of oxygen storage requirements. 4. During an interview on 11/25/2024 at 3:18 PM, the Administrator indicated that oxygen canisters should not be sitting directly on the floor.”

“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: 44230 Based on observation, record review and interview, the facility staff failed to provide appropriate infection control practices that would assist in preventing the spread of communicable diseases in 2 of 2 dialysis station set ups observed, (RN 6, PCT 2), 2 of 2 dialysis station disinfections observed, (PCT 3, PCT 2),1 of 2 observations of discontinuing treatment (RN 6), and 1 of 1 Home Program observations (RN 4). Finding include: 1. A 11/06/2023 policy titled, “Personal Protective Equipment” indicated but was not limited to, “Staff must remove gloves and wash hands after: Patient care ... Exposure to blood and body fluids ... Touching any surfaces within the patient station ... If hands are not visibly soiled, an alcohol-based sanitizer may be used ... Always perform hand hygiene after glove removal ... Avoid touching surfaces with gloved hands that will be touched with ungloved hands (for ex. patient chart and computers)”. 2. During an observation on 11/25/2024 at 10:20 AM, RN 6 was observed setting up a dialysis station. RN 6 removed her gloves, hand hygiene was not completed, walked over to the supplies and obtained a laboratory tube, returned to the station and put clean gloves back on without performing hand hygiene. RN 6 failed to preform appropriate hand hygiene with glove use. 3. During an observation on 11/25/2024 at 10:25 AM, RN 6 failed to complete hand hygiene prior to putting on clean gloves when discontinuing a treatment at Station #7. 4. During an observation on 11/26/2024 at 10:22 AM, PCT 2 was observed continually adjusting her face mask, face shield, hair throughout the disinfection of the dialysis station, Station 11, with gloved hands. PCT 2 failed to change gloves and/or complete hand hygiene. 5. During an observation on 11/26/2024 at 10:37 AM, PCT 2 was setting up Station #2. Clean gloves donned, PCT 2 adjusted her facemask and hair several times while stringing the dialysis machine, and spiked the new saline bag, failing to complete hand hygiene and change gloves when contaminated. 6. During an observation on 12/2/2024 at 11:07 AM, RN 4 removed Patient #4’s personal items from the bedside tray with clean gloves on, then placed her face shield on her head, set a clean under pad on the bedside tray, placed clean supplies on the under pad and completed venipuncture on Patient #4. RN 4 failed to change gloves once contaminated and perform appropriate hand hygiene prior to the venipuncture. 7. During an interview on 11/26/2024 at 11:30 AM, PCT 2 indicated that contaminated gloves should be removed, hands cleaned, and new gloves donned.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 44230 Based on observation, record review, and interview, the facility failed to ensure a clean under pad was placed beneath the Central Venous Catheter (CVC) limbs prior to discontinuing treatment in 2 of 2 CVC observations. (Patient #2, Patient # 4) Findings include: 1. A policy 11/4/2024 policy titled, “Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer” indicated but was not limited to, “Prior to Termination Preparation: 5. Ensure that a clean under pad is below the catheter limbs to protect the work area and the clothing”. 2. During an observation on 11/25/2024 at 9:56 AM, PCT 1 failed to replace the soiled under pad when discontinuing treatment of a CVC, Patient #2. 3. During an observation on 11/25/2024 at 10:27 AM, PCT 1 failed to replace the soiled under pad when discontinuing treatment of a CVC, Patient #4. 4. During an interview on 12/4/2024 at 12:55 PM, PCT 1 indicated the under pad used at initiation of treatment is used at discontinuation of treatment and not changed unless observed to be soiled. The under pad remains on the patient throughout treatment.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 44230 Based on observation, record review, and interview, the facility failed to keep the water room locked and secure for 1 of 1 facility reviewed. Findings include: 1. A 09/05/2023 policy titled, “Physical Security and Facility Access” indicated but was not limited to, “Water Treatment Area Security: Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment. The facility must be maintained to prevent unwanted entry by outside persons not involved in the daily operation of the clinic. This is accomplished by: Locking all doors that allow access to the water treatment equipment. No exterior building door will be left unlocked unless under the continual supervision of a facility staff member”. 2. During the flash tour observation on 11/25/2024 at 9:25 AM, the water room evidenced an unlocked/unsecured door. Staff were not present inside the water room. 3. During an interview on 11/25/2024 at 09:30 AM, the Area Team Operations Manager (ATOM) indicated the water room should be locked/secured when unattended by staff. 4. During an interview on 11/26/2024 at 12:55 PM, the Biomed indicated the water room is to be locked when unattended by staff.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 44230 Based on record review and interview, the facility failed to ensure chlorine testing was completed every 4 hours with one staff member being a licensed RN for 1 of 1 facility reviewed. Finding include: 1. A policy dated 11/07/2022, titled “Carbon Filtration Monitoring for Incenter Central Water Systems Policy” indicated but was not limited to, “Two trained staff members, one of whom must be a licensed RN, will perform and verify total chlorine testing. Both staff members must be present. One staff member will perform the test while the other staff member observes the test being performed. If both staff members are unable to be present at the time of testing, then each must perform the test individually, comparing the results ... Worker Carbon Filter ... When to test ... prior to the initiation of the first patient treatment of the day and at a minimum of every four hours”. 2. A document titled “Post RO [Reverse Osmosis) with 1 Holding Tank - TCL -1[Total Chlorine Log] (54641)” indicated on 10/08/2024 PCT 4 and the Area Team Operations Manager (ATOM) obtained the initial chlorine test for the treatment day. The facility failed to ensure a licensed RN completed the chlorine/chloramine test. 3. A document titled, Post Worker Carbon Tank - TCL -1” indicated a chlorine test completed on 10/08/2024 at 8:15 AM by RN 6. 4. A document titled, Post Worker Carbon Tank - TCL -1” indicated the following late chlorine test completed: 11/16/2024: 3:51 AM and 8:15 AM (4 hours and 24 minutes), 11/19/2024: 4:40 AM and 9:44 AM (5 hours and 4 minutes), 11/24/2024: 11:30 AM with no additional chlorine test completed. Last treatment of the day ended at 4:03 PM (4 hours and 33 minutes), 10/04/2024: 7:45 AM and 11:49 AM (4 hours and 4 hours and 4 minutes), 10/24/2024: 5:30 AM and 9:40 AM (4 hours and 10 minutes), 09/07/2024: 4:45 AM and 8:58 AM (4 hours and 13 minutes) and 09/10/2024: 7:40 AM and 12:21 AM (4 hours and 41 minutes). 5. A treatment sheet for Patient #5, dated 11/24/2024, indicated an end treatment time of 4:03 PM. 6. During an interview on 11/26/2024 at 2:51 PM, the Administrator indicated that the last treatment of the day on 11/24/2024 ended at 4:03 PM, Patient #5. Staff should have completed an additional chlorine check by 3:30 PM. 7. During an interview on 11/26/2024 at 1:45 PM, the ATOM indicated that an RN and another trained staff member must complete each chlorine test. The ATOM verified that an RN did not sign off on the chlorine test completed on 10/08/2024. She attributed this oversight to consistently changing float staff and/or computer sign-off failure, which led to charting values under the wrong user. Staff should complete chlorine checks every 4 hours. 8. During an interview on 11/26/2024 at 1:50 AM, the Director of Operations indicated chlorine checks can be completed by two qualified staff members, not necessarily one being an RN, but will check the policy. 9. During an interview on 11/26/2024 at 2:26 PM, the Administrator indicated staff should complete chlorine checks every 4 hours. 10. During an interview on 11/26/2024 at 4:00 PM, the Director of Operations indicated that on 10/08/2024, if the ATOM did not sign out of the computer after documenting, the RN could have completed the chlorine test and just mistakenly charted it under the ATOM.”

“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: 44230 Based on record review and interview, the facility failed to ensure a monthly care plan was completed for 1 of 1 unstable patient record review. (Patient #1) Findings Include: 1. A 07/03/2023 policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” indicated but was not limited to, “The comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by the interdisciplinary team (IDT) consisting of at a minimum, the patient or patient’s designee, a registered nurse, the patient’s attending physician (or physician extender where allowed by State regulations), qualified master’s degree level social worker and qualified registered dietician ... The plan of care should be signed at the time of the interdisciplinary team meeting for those attending in person. If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDP member within 30 days of the interdisciplinary team meeting ... Unstable patients must be reassessed by the IDT monthly. Monthly reassessment and any POC updates related to the reason the patient is considered “unstable” must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the condition is chronic ... the physician is responsible for ensuring the completion of the medical portion of the CIA and reviewing the completed interdisciplinary CIA and Plan of Care”. 2. A review of Patient #1’s medical record evidenced an admission date of 08/29/2024. The initial care plan was completed on 10/31/2024, 61 days later, and the patient was deemed unstable. The RN and patient did not sign the completed care plan. No one provided documentation to ensure the staff informed the patient of the meeting outcome. The staff did not complete a follow-up unstable care plan scheduled on 11/30/2024. 3. During an interview on 11/25/2024 at 12:50 PM, the medical director indicated that RN 6 was new and needed continual assistance completing tasks, specifically care plans. 4. During an interview on 12/2/2024 at 9:44 AM, the Administrator indicated that staff should assess unstable patients and complete a plan of care monthly. Staff did not complete Patient #1’s monthly care plan in November 2024. 5. During an interview on 12/2/2024 at 9:48 AM, the Interim Clinic Manager indicated the social worker was responsible for notifying staff when all care plans were due. The Interim Clinic Manager indicated that the staff missed the monthly unstable care plan due to the social worker’s vacation. 6. During an interview on 12/2/2024 at 10:02 AM, the Interim Clinic Manager indicated she could not find a signed 10/30/2024 initial/unstable care plan in the patient’s clinical record. 7. During an interview on 12/2/2024 at 2:09 PM, the Interim Clinic Manager indicated assisting the new nurse with training on care plans and other RN tasks but has been short on time. 8. During an interview on 12/3/2024 at 2:20 PM, RN 6 indicated that care plans, when deemed unstable, should be completed monthly. RN 6 further indicated that as a new RN to the facility, she was given a lot of responsibilities too quickly and has difficulty completing RN tasks, including care plans, in a timely manner. Staff did not complete Patient #1’s care plan for November 2024 due to time constraints. The social worker provides her with a list of care plans to be completed for the month but does not provide this list in a more manageable time frame. If received earlier, RN 6 may be able to complete them on time. She continues learning to document assessment findings in the care plan and correctly complete orders.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 44230 Based on record review and interview the facility failed to ensure staff completed a Plan of Care for 4 of 5 Incenter Hemodialysis patients record reviews. (Patient #1, #2, #3, #5) Findings include: 1. A 07/03/2024 policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” indicated but was not limited to, “An Interdisciplinary Comprehensive Assessment and Plan of Care must be completed by the interdisciplinary team members, per the frequency outlined in the Conditions for Coverage ... The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, the patient or patient’s designee, a registered nurse, the patient’s attending physician (or physician extender where allowed by State regulations), qualified master’s degree level social worker and qualified registered dietitian ... The Comprehensive Assessment and Plan of Care (adult patient) must be completed electronically in the patient’s medical record. The Plan of care should be signed at the time of the interdisciplinary team meeting for those attending in person. If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDP member within 30 days of the interdisciplinary team meeting ... The patient’s Plan of Care will be guided and developed based on the findings identified in the Comprehensive Interdisciplinary Assessment ... Patient stability must be reviewed monthly ... The frequency of the Comprehensive Interdisciplinary Assessment and Plan of Care are determined by the stability of the patient as determined by the physician, with input from the IDT”. 2.The medical record for Patient #1 indicated an admission date of 08/29/2024. The initial RN, social worker, and dietician completed the comprehensive assessments; however, the plan of care was not developed and implemented within 30 days or 13 treatments. The care plan meeting was on 10/31/2024, 63 days after admission. The Registered Nurse or patient did not sign the 10/31/2024 initial care plan. 3. The medical record for Patient #2 indicated an admission date of 08/27/2024. The initial RN, social worker, and dietician comprehensive assessments were completed however the facility failed to ensure the initial care plan was developed and implemented. 4. The medical record for Patient #3 indicated an admission date of 09/02/2024. The initial RN, social worker, and dietician completed the comprehensive assessments; however, the facility failed to ensure the initial care plan was developed and implemented. 5. The medical record for Patient #5 indicated an admission date of 08/12/2024. The initial social worker and dietician completed the comprehensive assessments; however, the initial RN assessment was not completed. The facility staff failed to complete the initial RN comprehensive assessment and failed to ensure the initial care plan was developed and implemented. 6. During an interview on 12/3/2024 at 2:20 PM, RN 6 indicated that care plans, when deemed unstable, should be completed monthly. RN 6 further indicated that as a new RN to the facility, she was given a lot of responsibilities too quickly and has difficulty completing RN tasks, including care plans, in a timely manner. Staff did not complete Patient #1’s care plan for November 2024 due to time constraints. The social worker provides her with a list of care plans to be completed for the month but does not provide this list in a more manageable time frame. If received earlier, RN 6 may be able to complete them on time. She continues learning to document assessment findings in the care plan and correctly complete orders. 7. During an interview on 12/3/2024 at 2:35 PM, the Administrator indicated staff did not complete the initial care plans for Patients #2, #3, and #5. Staff should have completed Patient #1’s care plan in 30 days or 13 treatments and signed by the RN. 8. During an interview on 12/3/2024 at 11:06 AM, the Director of Operations indicated that the staff provided all assessments for Patients #1, #2, and #3; however, the RN did not complete the comprehensive assessment for Patient #5. 9. During an interview on 11/25/2024 at 12:50 PM, the medical director indicated that RN 6 was new and needed continual assistance completing tasks, specifically care plans. .”

“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: 44230 Based on observation, record review, and interview, the facility staff failed to ensure expired supplies and medications were appropriately discarded, medications were secured from unauthorized access, and pre-drawn medications were properly labeled for 1 of 1 facility reviewed. Findings include: 1. A 04/05/2021 policy titled, “Storage of Supplies” indicated but was not limited to, “Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date”. 2. A 02/06/2023 policy titled, “Medication Preparation and Administration” indicated but was not limited to, “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 law ... Securement: All medications will be kept in a locked cabinet except when in use. One key to the medication cabinet will be kept by the charge nurse/team leader. The Clinical Manager will retain a spare key, kept in secure location. The key to the medication cabinet will be kept in a secure location when the facility is closed. Only the clinical manager, charge nurse and team leader will have access to the location. When the charge nurse/team leader leaves the treatment area, the key will be left in the possession of other qualified, licensed personnel ... All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time, and initials of the person who prepared the medication ... Oral medications not being administered immediately must also be labeled as indicated above”. 3. A 05/01/2023 policy titled, “Emergency Medications, Equipment and Supplies” indicated but was not limited to, “The emergency cart must be: Locked when not in use, checked monthly or after use for contents, expiration date”. 4. During an observation on 11/25/2024 at 9:25 AM, the water room evidenced one bottle of MesaLabs Standard Buffer Solution (solution used to calibrate meters for pH and conductivity) expired on 10/11/2024. 5. During an observation of the treatment floor on 11/25/2024 at 10:12 AM the storage drawer evidenced one box of Crit-Line CLiC Blood chambers (used on the dialysis machine to assist in determining fluid removal) expired on 10/31/2024. 6. During on observation of the treatment floor on 11/25/2024 at 10:37 AM, the surveyor found the medication cabinet unlocked/unsecured. This cabinet housed all treatment medications and emergency medications that did not require refrigeration. Five medication cups with patient labels affixed to the side contained oral medications. The label did not provide the staff initials or the time staff set up the medications. Fifteen vials of 100 milligrams (mg) Venofer (Intravenous medication used to treat anemia) were sitting on the counter at the medication preparation area, unsecured and unattended. 7. During an observation of the treatment floor on 11/25/2024 at 11:03 AM, the unsecured medication cabinet evidenced Nalozone Hydrochloride 0.4 mg vials (medication used to treat Opioid-induced depression) expired on 09/2024. 8. During an observation of the treatment floor on 11/25/2024 at 11:14 AM, the mediation refrigerator evidenced five doses of Prevnar 13 (pneumonia vaccine) and eight vials of Parsabiv 10 mg (medication used to treat an overactive parathyroid). All medications expired on 09/2024. 9. During an observation of the treatment floor on 11/25/2024 at 11:14 AM, the medication preparation counter evidenced five patient medication cups containing unattended oral medications by licensed staff. RN 6, the only RN working on the treatment floor, was observed assisting a patient with treatment at Station 6. 10. During an observation of the treatment floor on 11/25/2024 at 11:17 AM, the surveyor found the emergency crash cart unlocked/unsecured with medications inside. 11. During an observation of the treatment floor on 11/25/2024 at 11:23 AM, a lockbox was located on the counter in front of the nurse’s station near the patient scale/handwashing station and exit door to the lobby. The lockbox was left open and unattended and contained 10 Heparin (medication used to prevent clotting during dialysis) vials, 30,000 units/30 milliliters plus one partially used vial. The surveyor found 10-milliliter syringes and patient medication labels in an opened lockbox. 12. During an observation of the treatment floor on 11/25/2024 at 11:27 AM, the surveyor found a storage cart evidencing thirty-six clear/red top laboratory tubes to have expired on 09/30/2024. 13. During an observation of the Home Dialysis Area on 11/25/2024 at 11:45 AM a drawer in the treatment/training room evidenced 22 ChloraPrep Single Swabsticks (used to disinfect skin) that had expired on 07/2024. 14. During an observation of the Home Dialysis Area on 11/25/2024 at 11:50 AM, a cabinet in the laboratory area evidenced Culture Swab Plus (used culture skin) that had expired on 10/16/2024 and clear/red top laboratory tubes expired on 10/31/2024. 15. During an observation of the Home Dialysis Area on 11/25/2024 at 11:59 AM, the Home Administrative Assistant was asked where the Home Dialysis medications were kept. She walked the surveyor to the cabinet that housed the medications and found the cabinet was locked. She left and returned with a key and opened the cabinet for the surveyor. 16. During an observation on 11/27/2024 at 11:27 PM the nurse’s station medication counter evidenced a pre-filled syringe of Venofer for Patient #8, left unattended. A lockbox at the nurse’s station evidenced Heparin inside, which was unlocked/unattended. 17. During an observation on 12/04/2024 at 9:32 AM, PCT 1 was observed drawing up Heparin before the patient arrived. PCT 1 drew up the medication, placed a label on the syringe, and placed the syringe back into the Heparin lockbox, failing to label the syringe with the initials of the preparer and the time staff prepared the medication. 18. During an interview on 11/25/2024 at 10:52 AM, the InCenter Hemodialysis Administrative Assistant indicated having access to all medications. She assists the RN with ordering, organizing, and monitoring for expired medications. She also indicated that she was not a Licensed nurse but was a PCT; however, she does not work as a PCT anymore. 19. During an interview on 11/25/2024 at 10:52 AM, RN 6 indicated that medication cabinets are left unlocked all day and secured at the end of the day. If leaving the treatment floor, staff would lock the cabinet. Venofer was left out on the counter throughout the day. RN 6 indicated that she frequently assists with initiating and discontinuing patient treatments throughout the day, and medications are unsecured during this time. 20. During an interview on 11/25/2024 at 11:28 AM, RN 6 indicated that expired supplies should be discarded and not used. She was unaware the crash cart was not locked and had personally inventoried it this past Sunday. 21. During an interview on 11/25/2024 at 12:14 PM, the Home Program Manager indicated that only nurses can access the medications. The manager then questioned whether the surveyor had asked the Administrative Assistant to open the cabinet. It was advised that the assistant was only asked to show the surveyor where the medications were located. The Home Program Manager was provided all supplies found to be expired in the home department. 22. During an interview on 11/25/20204 at 12:25 PM, RN 4 stated that all expired supplies should be discarded and that only licensed nurses should have access to medications.”

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 44232 Based on record review and interview the facility failed to ensure the Emergency totes contained updated patient and staff emergency contact information, and the patient’s dialysate orders for all active patients receiving treatments in-center and home dialysis per the facility policy in 2 of 2 Emergency totes observed. Findings Include: 1. On 11-14-2023 at 1:30 PM, a dated 07-03-2023, Fresenius Kidney Care policy titled, “Guidelines for Emergency Preparedness” was provided by the Director of Operations (DO). The policy indicated but was not limited to, “... Create and maintain staff, patient and facility emergency information contact lists ...” 2. During a flash tour observation on 11-13-2023 at 10:40 AM, the Emergency cart was reviewed. The Emergency cart contained in the top drawer the patient’s demographics and dialysis treatment orders which were last updated on 07-08-2023 and did not include the current patients or employees. 3. During a flash tour on 11-13-2023 at 10:50 AM, the Emergency box behind the nurse’s station was reviewed. The Emergency box failed to evidence an emergency patient contact list, employee emergency contact list, and the patients’ dialysis treatment orders. During an interview on 11-13-2023 at 10:50 AM, the Patient Care Technician (PCT) 2, confirmed the in-center patient contact information dated 07-08-2023, did not contain all the current patient’s information. PCT 2 further indicated the emergency Code Cart had not been checked off for the month of October 2023. 4. On 11-13-2023 at 12:35 PM, during an observation of the Home Emergency box was reviewed. The Emergency box contained the patient’s demographics and dialysis treatment orders which were last updated on 9-27-2023 and did not include the current patients or employees. 5. On 11-13-2023 at 12:45 PM, reviewed an agency document titled, “Emergency Box Contents Log Home Therapy (HHD and PD) -Monthly.” The document indicated the Emergency box was audited on 11-10-2023 at 3:30 PM. During an interview on 11-13-2023 at 1:00 PM, The Registered Nurse (RN) 2, confirmed the patient list was not accurate. RN 2 indicated they were to check the Emergency box monthly to ensure the patient information was updated and accurate. 6. During an interview on 11-14-2023 at 3:30 PM, the DO, confirmed the In-center, Home dialysis patient, and employee contact list and information was to be in the Emergency boxes for In-center and the Home Program. The DO further confirmed the patient and staff information was to be updated monthly.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to ensure emergency medications and supplies were checked for expiration dates and failed to complete their monthly itemized log per the facility policy for 2 of 2 Emergency Carts observed. Findings include: 1. On 11-14-2023 at 1:30 PM, a dated 07-06-2020, Fresenius Kidney Care policy titled, “Emergency Medication, Equipment, and Supplies” was provided by the Director of Operations (DO). The policy indicated but was not limited to, “Emergency Cart ... The emergency cart must be: ... Checked monthly or after use for contents, expiration dates ... An itemized log must be kept indicating the contents and expiration dates of contents. Items approaching expiration must be reordered and replaced prior to the actual expiration date ...” 2. During the flash tour observation on 11-13-2023 at 10:40 AM, the in-center Emergency Cart contents were reviewed. The emergency Cart contained 2 boxes of Atropine Sulfate (used to treat cardiac arrest) 1 milligram (mg)/10 milliliters (ml) (0.1 mg/ml) 10 ml single dose injections with an expiration date of August 2023, 4 vials of Adrenalin (a medication used for emergency treatment of a severe reaction) 1 mg/ml with an expiration date of September 2023, 1 Intravenous (IV) therapy administration line kit (used for controlled infusion of medications to the needle) with an expiration date of 10-18-2023, and 2 Yankauer suction sets (a rigid catheter designed for emergency airway management) with an expiration date of 10-03-2023. During an interview on 11-13-2023 at 10:45 Am, the Patient Care Technician (PCT) 2, confirmed the medication and supplies were expired, and the Registered Nurse (RN) was to order those. The PCT further indicated the Emergency Cart was to be checked monthly for expired supplies and medications. 3. On 11-13-2023 at 12:45 PM, the Emergency Cart of the Home program was reviewed. The Emergency Cart contained 1 Yankauer suction sets (a rigid catheter designed for emergency airway management) with an expiration date of 10-03-2023. 4. On 11-13-2023 at 12:45 PM, reviewed an agency document titled, “Emergency Code Cart and Medications Checklist Monthly.” The document indicated the Emergency Cart was audited on 11-10-2023 at 3:03 PM and the section titled, “Verify Yankauer is present” was marked yes. During an interview on 11-13-2023 at 1:00 PM, The Registered Nurse (RN) 2, confirmed they were to check the Emergency Cart monthly to ensure supplies and medications had not expired. 5. During an interview on 11-13-2023 at 4:15 PM, the Director of Operations (DO), confirmed that the Emergency Cart was to be checked monthly for expired medications and supplies.”

“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: 44232 Based on observation, record review, and interview the facility failed to demonstrate appropriate infection control practices, hand hygiene, and use of Personal Protective Equipment (PPE) appropriately while on the treatment floor by 3 of 3 Patient Care Technicians and 3 of 3 Registered Nurses (RN). (Patients: # 7, 8, 11, 12, 13, 14, 15, 17, 21, 22, and 25) (Employees: PCT 2 (7 times), 3 (3 times), 4 (twice), RN 1, 5 (twice), and 6) Findings include: 1. On 11-14-2023 at 1:30 PM, a dated 03-17-2023, Fresenius Kidney Care policy titled, “Hand Hygiene” was provided by the Director of Operations (DO). The policy indicated but was not limited to, “Purpose: The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination ... Hand Hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content ... Hand Hygiene: Patients. Patients should perform hand hygiene if able, prior to and after each dialysis treatment. As needed, direct patient care staff will demonstrate how to operate the sinks, demonstrate handwashing, to patients who are able to perform hand washing, and explain the risk of contamination with regard to their vascular access and hands to all patients ... holding access sites post treatment to achieve hemostasis ... “ 2. On 11-13-2023 at 11:00 AM a sign posted on the wall above the sink at the entrance to the treatment area was reviewed. The sign titled, “Hand Hygiene Techniques” provided pictures and written instructions on how to complete a hand wash and how to complete a hand rub with hand sanitizer which indicated the best practice to prevent infection. 3. On 11-13-2023 at 2:30 PM, a facility document dated December 2022 through November 2023, titled “Clinic Audit Checklist, Category: Infection Prevention” was provided by the DO. The document indicated a review of the monthly infection prevention audits completed. 4. On 11-13-2023 at 2:05 PM, PCT 2 was observed to don gloves without performing hand hygiene answer Station #6’s dialysate machine alarm and discarded their gloves in the trash receptacle beside the chair. The PCT donned new gloves without performing hand hygiene and answered the dialysate machine alarm at Station #8, PCT 2 discarded their gloves in the trash receptacle, donned new gloves and began the discontinuation of dialysis treatment for Patient #12 at station #7. PCT 2 failed to perform hand hygiene after they discarded their gloves and prior to donning new gloves. 5. During an observation on 11-13-2023 at 3:30 PM, the Registered Nurse (RN) 5, removed the glove from Patient #7’s right hand after they held their left vascular access site and discarded the glove in the trash receptacle at Station #8. The RN assisted Patient #7 to the scale to obtain their weight prior to the patient leaving the treatment area. Patient #7 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 6. During an observation on 11-13-2023 at 3:35 PM, RN 6, removed the glove from Patient #14’s right hand after they held their left vascular access site and discarded the glove in the trash receptacle at Station #6. The RN assisted Patient #14 to the scale to obtain their weight prior to the patient leaving the treatment area. Patient #14 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 7. During an observation on 11-13-2023 at 3:45 PM, PCT 2, discontinued the treatment for Patient #12, at Station #7. Patient #12 held pressure on the left lower vascular access site with a gloved right hand. Patient #12 discarded their glove in the trash receptacle beside their chair. PCT 2 obtained Patient #12’s weight prior to the patient leaving the treatment area. Patient #12 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 8. During an observation on 11-13-2023 at 3:55 PM, PCT 2 was observed cleansing the area around Patient #13’s CVC exit site with antiseptic. The PCT went to the drawer of the center island obtained a sterile dressing, removed their gloves, and discarded them into the trash receptacle. PCT 2 donned new gloves and applied the sterile dressing to Patient #13’s exit site. PCT 2 failed to perform hand hygiene and done new gloves prior to applying the CVC dressing. 9. During an observation on 11-14-2023 at 11:59 AM, PCT 4 was placed a clean barrier under the CVC ports of Patient #13. The PCT discarded their gloves, went to the cabinet obtained alcohol pads, donned new gloves, and cleansed the CVC hubs using the alcohol pads. PCT 4 failed to perform hand hygiene and don new gloves prior to disinfecting the hubs of Patient #13’s CVC ports. 10. During an observation on 11-14-2023 at 8:05 AM, Patient #15 walked to and from the patient bathroom from Station #7 in their socks. Patient #15 made RN 1 aware they needed to use the bathroom prior to initiation of dialysis treatment. The RN failed to instruct or assist Patient #15 with their shoes prior to walking on the treatment floor in their socks. 11. During an observation on 11-14-2023 at 10:50 AM, PCT 4, was observed assisted Patient #22, at Station #9, after the patient held pressure on their left vascular access site with a gloved right hand. Patient #22 discarded their glove in the trash receptacle beside their chair. PCT 4 assisted Patient #22 with their belongings to the scale to obtain Patient #22’s weight. Patient #22 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 12. During an observation on 11-14-2023 at 10:54 AM, Patient #8, at Station #8, was observed to hold pressure on their left lower vascular access site with a right gloved hand. Patient #8 discarded their glove in the trash receptacle beside their chair added more tape to their left lower vascular access dressing, went to the scale and obtained their weight, and left the treatment area. Patient #8 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 13. During an observation on 11-14-2023 at 11:00 AM, PCT 3, was observed assisting Patient #25, at Station #12, after the patient held pressure on their left vascular access site with a gloved right hand. Patient #25 discarded their glove in the trash receptacle beside their chair. PCT 3 obtained Patient #25’s weight prior to the patient leaving the treatment area. Patient #25 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 14. During an observation on 11-14-2023 at 11:00 AM, PCT 3, was observed assisted Patient #21, at Station #1, after the patient held pressure on their left vascular access site with a gloved right hand. Patient #21 discarded their glove in the trash receptacle beside their chair. PCT 3 assisted Patient #21 to the scale to obtain their weight. Patient #2 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. 15. During an observation on 11-14-2023 at 11:59 AM, PCT 4 was placed a clean barrier under the CVC ports of Patient #13. The PCT discarded their gloves, went to the cabinet obtained alcohol pads, donned new gloves, and cleansed the CVC hubs using the alcohol pads. PCT 4 failed to perform hand hygiene and don new gloves prior to disinfecting the hubs of Patient #13’s CVC ports. 16. During an observation on 11-14-2023 at 12:15 PM, PCT 3, Patient #17, at Station #10, was observed to hold pressure on their right vascular access site with a left gloved hand. Patient #17 discarded their glove in the trash receptacle beside their chair. PCT #3 assisted Patient #17 to the scale to obtain their weight prior to the patient leaving the treatment area. Patient #17 was not offered hand sanitizer or instructed to perform hand hygiene before leaving the treatment floor. During an interview on 11-14-2023 at 3:45 PM, RN 1 confirmed hand hygiene should be offered or instructed to the patients after they held their pressure dressing on their vascular assess site. 17. On 11-14-2023 at 4:19 PM, a review of the Personnel record for PCT 2, contained a facility document titled, “Fresenius Medical Direct Patient Care-Skills Validation Checklist.” The section subtitled, “Infection Control Skill Components” indicated PCT 3 successfully provided cognitive review and demonstrated the following: appropriate Personal Protective Equipment (PPE), hand washing, and correct glove changes on 03-20-2023. 47343 18. During an observation on 11-13-2023 at 2:20 PM, RN 5 was observed assisting Patient #11, while they were experiencing symptoms of hypotension (low blood pressure). RN 5 failed to change gloves and perform hygiene prior to touching the patient and after touching the screen of the Dialysis machine. 19. During an observation on 11-13-2023 at 3:55 PM, PCT 2 went from touching the screen on the machine to Patient #13. PCT 2 failed to don new gloves and sanitize hands prior to touching the patient. PCT 2 was observed discontinuing the lines from the patient’s right upper extremity fistula. PCT 2 failed to perform hand hygiene prior to donning new gloves after they disconnected the bloodlines. PCT 2 failed to perform hand hygiene prior to donning clean gloves, when the patient’s access site was no longer bleeding. Patient #13 held their access site and PCT 2 failed to offer the patient hand sanitizer once hemostasis was achieved. 20. During an interview with RN 5 on 11-13-2023 at 4:05 PM, they indicated their hands were to be sanitized before putting the patient on Dialysis, taking them off of Dialysis, after using the restroom, and when soiled. RN 5 indicated they did not have to change their gloves when going from the machine to the patient. 21. During an interview with PCT 2 on 11-13-2023 at 4:25 PM, they indicated they were to sanitize their hands after changing gloves, when removing gloves, every time they touch the machine or patient, when soiled, when changing gloves when going from the machine to the patient, and patient to machine.”

“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: 44232 Based on observation, record review, and interview the facility failed to ensure the staff and patients wore masks while on the treatment floor for 1 of 1 stand alone in-center dialysis centers. (Employee: Patient Care Technician, PCT 2, (twice) Patient #4, 19 and 20 Findings include: 1. On 11-14-2023 at 1:30 PM, a dated 03-17-2023, Fresenius Kidney Care policy titled, “Personal Protective Equipment” was provided by the Director of Operations (DO). The policy indicated but was not limited to, “ ... Facemask creates a physical barrier to help block large particles, splashes, sprays, or splatter from reaching the mouth and nose ...” 2. On 11-13-2023 at 9:15 AM a sign posted on the front entrance door to the dialysis treatment facility was reviewed. The sign stated, “Due to the increase in COVID cases. Masks are required to enter the facility.” 3. During an observation on 11-13-2023 at 3:20 PM, the Patient Care Technician (PCT) 2, was observed improperly wearing their mask below their chin while on the treatment floor at Station #6 discontinuing Patient #12’s dialysis treatment. 4. During an observation on 11-14-2023 at 7:35 AM, PCT 2 was observed improperly wearing their mask below their nose and mouth while at Station #9 addressing the dialysis machine alarm. 5. During an observation on 11-14-2023 at 12:15 PM, Patient #19, was observed at Station #1, not wearing a mask. Patient #4 at Station #6 was observed holding their mask. Patient #20 at Station #12 was observed not wearing a mask. 6. During an observation on 11-14-2023 at 1:35 PM, patients at stations 5, 7, and 9 had their masks under their chin. 7. During an observation on 11-14-2023 at 2:45 PM, observed the patients at Stations #1, 6, 8, 10 and 12 with no mask on during their treatment. During an interview on 11-14-2023 at 3:00 PM, the South Area Director of Operations, Corp 1, was advised of the patients observed on the treatment floor at Stations #1, 6, 8, 10, and 12 not wearing masks and staff improperly wearing masks during treatment. Corp 1 immediately reminded and reeducated staff to wear masks while on the treatment floor. 8. During an observation on 11-14-2023 at 3:30 PM the patients at Stations #1, 6, 8, 10, and 12 not wearing a mask during treatment. The patient at Station #7 was observed with no mask on during treatment with the Medical Social Worker (MSW) 1, on a stool in front of their station. During an interview on 11-14-2023 at 3:45 PM, the Registered Nurse (RN) 1, indicated the staff encourage the patients to wear mask. RN 1 further indicated the staff are to wear mask properly covering their nose and mouth.”

“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: 44232 Based on observation, record review, and interview, the facility failed to ensure the staff monitored and discarded expired medications and supplies monthly per the facility policies for 1 of 1 In-center dialysis nurse’s stations and 1 of 1 Home dialysis nurse’s stations. Findings Include: 1. On 11-14-2023 at 1:30 PM, a dated 02-06-2023. Fresenius Medical Care policy was provided by the Director of Operations (DO). The “Medication Preparation and Administration” policy indicated but was not limited to, “ ... When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (Patient Care Technician) ... must place the date and time the vial was opened on the medication label along with their initials ... Expiration dates for all stored medications are to be monitored on a monthly basis ... Any multi-dose vials must be discarded 28 days after opening or per the manufacturer’s expiration date ...” 2. On 11-14-2023 at 1:30 PM, a dated 07-04-2012. Fresenius Medical Care policy was provided by the DO. The “Expiration Dates Sterile Supplies” policy indicated but was not limited to, “... This policy provided guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date ... Appropriately dispose of sterile items that have reached the expiration date ...” 3. During a Flash tour on 11-13-2023 at 10:50 AM, observed in the medicine cabinet behind the in-center nurse’s station a box that contained 14 vials of Adrenaline (a medication used for emergency treatment of a severe reaction) 1 milligram (mg)/milliliter (ml) that expired September 2023, 4 boxes of Atropine Sulfate (used to treat cardiac arrest) 1 mg/10 ml (0.1 mg/ml) 10 ml single dose injections that expired August 2023, and 1 box of 2 containers Glucose Control Solution (a solution to do a quality control check on blood sugar monitoring machines) 2.5 ml. During an interview on 11-13-2023 at 10:50 AM, the Patient Care Technician (PCT) 2, confirmed the medications and supplies had expired. The PCT further indicated that the Registered Nurse (RN) 1, orders the medications and supplies after they are checked monthly. 4. During a flash tour observation on 11-13-2023 at 12:45 PM, observed on the counter of the Home dialysis nurse’s station 3 Bacterial sample vials (vials used to obtain blood samples to test for infections) 30 ml vials expired on 10-07-2023, and 5 red top BD vacutainers tubes (tubes used to obtain blood samples for testing) 6.0 ml expired on 08-31-2023. During an interview on 11-13-2023 at 1:00 PM, RN 2, confirmed the supplies had expired and they were to check medications and supplies monthly.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 47343 Based on record review and interview, the agency failed to ensure chlorine checks were performed every 4 hours for 1 of 1 chlorine log sheet reviewed. Findings Include: 1. On 11-13-2023 at 1:30 PM, the Area Teams Operation Manager (ATOM) provided a document titled “Log Name: Post Worker Carbon Tank”. The document evidenced on 10-23-2023 the test was read at 08:37 and the next time the test was read was at 15:36. The agency failed to ensure the chlorine test was checked and read every 4 hours. The document evidenced on 10-27-2023 the test was read at 04:40 and the next time the test was read at 09:19. The agency failed to ensure the chlorine test was checked and read every 4 hours. The document evidenced on 11-01-2023 the test was read at 05:00 and the next time the test was read was at 14:20. The agency failed to ensure the chlorine test was checked and read every 4 hours. 2. During an interview with the ATOM on 11-13-2023 at 11:50 AM, they indicated the chlorine tests were to be completed every 4 hours by 2 qualified individuals, with one having to be a nurse.”

“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: 44232 Based on observation, record review, and interview, the facility failed to provide a safe and comfortable environment for 1 of 1 stand one dialysis treatment centers. Findings include: 1. On 11-14-2023 at 1:30 PM, a dated 02-07-2022, Fresenius Kidney Care policy titled “General Cleanliness and Infection Control Guidelines” was provided by the Director of Operations (DO). The policy indicated but was not limited to, “ ... All areas must be kept clean and organized ... treatment area, water/supply room and offices. Walkways must be kept clear of debris and free of clutter ... Supplies or patient’s belongings should not be kept or stored behind the machine at the patient station ...” 2. During an observation on 11-13-2023 at 12:35 PM, noted 3 boxes on the floor of Home dialysis office door entry. During an interview on 11-13-2023 at 12:35 PM, the Patient Care Technician and Receptionist, PCT 1, indicated the boxes were full of a patient’s supplies. 3. During an observation on 11-13-2023 at 1:30 PM, noted 3 boxes of Christmas trees, 6 boxes of Liquacel on the floor of the storage room, in the hallway next to the conference room. During an interview on 11-13-2023 at 1:30 PM, the Area Operation Manager of Biomed Technicians, confirmed no boxes were to be on the floor. 4. During an observation on 11-13-2023 at 1:35 PM, observed the patient bathroom with a roll of toilet paper on the floor. 5. During an observation on 11-13-2023 at 1:40 PM, observed soiled gauze and gloves on the floor beside the trash receptacle at Station #7. 6. During an observation on 11-13-2023 at 2:15 PM, noted 3 gloves on the floor by the clean sink, 2 soiled 2 x 2 gauze dressings, and a normal saline syringe wrapper on the floor in front of Station #9. 7. During an observation on 11-13-2023 at 3:20 PM, noted on the surround unit wall shelf a dialysis cap behind Station #7, a blood pressure cuff behind Station #6, a cane behind Station #4, and a tan arm cushion between Station #7 and Station #8. 8. During an observation on 11-14-2023 at 7:45 AM, noted a blood pressure cuff on the surround unit wall shelf at Station #6. During an interview on 11-14-2023 at 3:45 PM, the Registered Nurse (RN) 1, confirmed nothing was to be on the surround unit shelf. 47343 9. On 11-13-2023 at 1:32 PM, it was observed in the storage room next to the offices, 13 cardboard boxes were on the floor and 2 of the boxes were on a black tarp. The agency failed to ensure the hallway was clear of boxes. 10. On 11-14-2023 at 11:50 AM, observed a box of gloves behind Station #10 on the chase wall.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 44232 Based on observation, record review, and interview, the facility failed to ensure the building was maintained to ensure the safety of patient and staff in 1 of 1 stand one dialysis treatment centers. Findings Include: 1. On 11-14-2023 at 1:30 PM, a 04-05-2021 Fresenius Kidney Care policy titled, “Storage of Supplies” was provided by the Director of Operations (DO). The policy indicated but was not limited to, “ All clean or sterile supplies ... must be stored off the floor ...”. 2. On 11-14-2023 at 1:30 PM, a 07-06-2021 Fresenius Kidney Care policy titled, “Equipment Installation-Operation-Maintenance-Repair-And Disposal” was provided by the DO. The policy indicated but was not limited to, “ ... Any equipment or device that is not fully functioning ... must be repaired or replaced as soon a reasonably possible ... Identified issues may include fluid leaks: nonfunctional, broken, or misadjusted parts and components; or aesthetic damages ...” 3. On 11-13-2023 at 10:30 AM, during a Flash tour, the water room was found to have crumbled flooring and when stepping around the area water appeared around the carbon filter tanks. There was no sign posted indicating the floor was wet. During an interview on 11-13-202311:16 AM, the Biomed Technician, indicated they had a work order for the floor and carbon filter tanks. 4. On 11-14-2023 at 10:40 AM, during the Flash tour observation, the black refrigerator in the lab area had dirt and debris on the bottom shelf, and the door facing, and sides had rust showing through the black paint. During an interview on 11-13-2023 at 1:30 PM, the Area Operation Manager of Biomed Technicians, confirmed no boxes were to be on the floor. 5. During an observation on 11-13-2023 at 2:08 PM, noted the sink in front of the nurse’s station with a green substance surrounding the connections of faucet, handles, and the green build up substance around the white pipe fitting below the sink. 6. On 11-13-2023 at 4:13 PM, facility documents titled, “Order No. 3602250300” dated December 23, 2022, and “Order No. 3602442089” dated April 3, 2023, was provided by the Area Operation Manager of Biomed Technicians. The documents indicated materials needed for repairs for the water room floor. 7. During an observation on 11-14-2023 at 11:35 AM, noted Station #3 had 4 floor tiles cracked and cement showing, and the baseboard behind Station #4 was missing. 8. During an observation on 11-14-2023 at 11:40 AM, noted behind Station #9 had floor tiles chipped, and behind Station #12 wall paint at the baseboard was peeling. 9. During an interview on 11-14-2023 at 9:00 AM, the Area Director of Biomed Technician, confirmed the treatment room sink faucet, handles and drain will need replaced. 47343 10. On 11-13-2023 at 10:35 AM, an observation of the treatment room evidenced a black refrigerator behind Patient Care Technician (PCT) station where labs were stored. The refrigerator had yellow rust on the bottom of the door. 11. On 11-14-2023 at 11:50 AM, an observation of the treatment room evidenced the wallpaper coming off of the wall at the bottom on the small wall in the corner of the PCT station. The bottom of the cabinet and lower drawer for the cabinet under the PCT station next to the printer had rust on it.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 44232 Based on observation and interview the facility failed to ensure the patient’s access site remained uncovered during dialysis treatments for 1 of 1 stand alone in-center dialysis facilities. (Patients: #15, 18, and 22) Findings Include: 1. On 11-14-2023 at 4:45 PM a dated 05-01-2023, Fresenius Kidney Care policy, titled, “Patient Assessment and Monitoring” was provided by the Director of Operations (DO). The policy indicated but was not limited to “Purpose: The purpose of this policy is to provide guidance to the Fresenius Kidney Care direct patient care staff on assessment and monitoring patients before, during, and after treatment ... Access: Ensure access remains uncovered throughout treatment ...” 2. During an observation on 11-14-2023 at 7:25 AM, Patient #22 was observed at Station #9. Patient #15’s access was fully covered with a maroon and white blanket. 3. During an observation on 11-14-2023 at 7:25 AM, Patient #18 was observed at Station #3. Patient #18’s Central Venous Catheter (CVC) was fully covered with a flowered blanket. 4. During an observation on 11-14-2023 at 10:50 AM to 12:35 AM, Patient #15 was observed at Station #7. Patient #15’s CVC was fully covered with a pumpkin blanket. During an interview on 11-14-2023 at 3:45 PM, the Registered Nurse (RN) 1, confirmed all patient’s accesses were to be visible at all times during their treatment.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 44232 Based on record review, and interview, the facility failed to ensure direct patient care staff monitored the patients during their dialysis treatment per the facility policy in 2 of 7 records reviewed. (Patients: #1, and 4) Findings Include: 1. On 11-14-2023 at 4:40 PM a dated 05-01-2023, Fresenius Kidney Care policy, titled, “Patient Assessment and Monitoring” was provided by the Director of Operations (DO). The policy indicated but was not limited to “The purpose of this policy is to provide guidance ... direct care staff on assessment and monitoring patients before, during and after treatment ... During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes ... “ 2. The medical record/treatment sheets for Patient #1 were reviewed on 01-14-2023. The treatment sheets from 10-23-2023 through 11-13-2023 evidenced the following: A. Treatment sheet dated 10-27-2023, a blood pressure, and pulse check at 1:32 PM by the Patient Care Technician (PCT). The following patient assessment was completed by the Registered Nurse (RN) at 3:03 PM. No abnormal blood pressure’s were noted. B. Treatment sheet dated 10-30-2023, a blood pressure, and pulse check at 2:30 PM by the PCT. The PCT completed the next blood pressure, and pulse check at 4:23 PM. No abnormal blood pressure’s were noted. C. Treatment sheet dated 11-06-2023, a blood pressure, and pulse check at 2:07 PM by the PCT. The PCT completed the next blood pressure, and pulse check at 3:04 PM. No abnormal blood pressure’s were noted. D. Treatment sheet dated 11-08-2023, a blood pressure, and pulse check at 2:04 PM by the RN. The following patient assessment and machine safety check was completed by the RN at 3:03 PM. No abnormal blood pressure’s were noted. E. Treatment sheet dated 11-10-2023, a blood pressure, pulse, and machine safety check at 1:30 PM by the PCT. The PCT completed the next blood pressure, and pulse check at 2:39 PM. No abnormal blood pressure’s were noted. During an interview on 11-13-2023 at 9:30 AM, the Medical Director, indicated the facility had struggled with not enough staff. The Medical Director further indicated they had some staff walk out last week after letting some staff go for not providing quality care after being retrained. 3. The medical record/treatment sheets for Patient #4 were reviewed on 01-14-2023. The treatment sheets from 10-21-2023 through 11-11-2023 evidenced the following: A. Treatment sheet dated 10-21-2023, a blood pressure, and pulse check at 12:34 PM by the RN. The RN completed the next blood pressure, pulse, and machine safety check at 1:32 PM. At 3:03 PM the PCT completed a blood pressure, pulse, and machine safety check. The RN completed the next blood pressure, pulse and machine safety check at 4:00 PM. No abnormal blood pressure’s were noted. B. Treatment sheet dated 10-24-2023, Patient #4’s treatment was initiated at 11:36 AM by the PCT. The RN completed blood pressure, pulse, and machine safety at 12:34 PM. No abnormal blood pressure’s were noted. C. Treatment sheet dated 10-28-2023, a blood pressure, pulse, and machine safety check at 2:01 PM by the PCT. The RN completed the next blood pressure, pulse, and machine safety check at 3:03 PM. No abnormal blood pressure’s were noted. D. Treatment sheet dated 11-04-2023, a blood pressure, pulse, and machine safety check at 11:44 AM by the PCT. The PCT completed the next blood pressure, pulse, and machine safety check at 12:31 PM. No abnormal blood pressure’s were noted. E. Treatment sheet dated 11-07-2023, a blood pressure, pulse, and machine safety check at 2:01 PM by the RN. The RN completed the next blood pressure, pulse, and machine safety check at 3:02 PM. No abnormal blood pressure’s were noted. F. Treatment sheet dated 11-11-2023, a blood pressure, pulse, and machine safety check at 2:31 PM by the PCT. The PCT completed the next blood pressure, and pulse check at 3:34 PM. No abnormal blood pressure’s were noted. During an interview on 11-14-2023 at 4:30 PM, the DO, confirmed Patient #4 was not monitored every 30 minutes with 45 minute maximum per their policy. No further information was provided.”