Fmc- Logansport Dialysis

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to provide a safe environment specific to staff following policy and best practice when transferring a patient with a Hoyer mechanical lift for 1 of 1 observation of a patient transfer with a Hoyer lift (Patient #46) and when completing pre-treatment safety checks for 3 of 9 treatment initiations observed on 7/19/24 (Patients #2, 36, 46). Findings include: 1. The review of facility policy #45268 titled “Guidelines for Use of the Hoyer Lift,” dated 7/01/24, indicated “there must be a minimum of two (2) staff members by the patient during the transfer process ....” When transferring a patient from a wheelchair to a treatment chair, staff were to lock the wheelchair in place prior to beginning the transfer. 2. The review of facility policy #47798 titled “Pre-Treatment Safety Checks Procedure,” dated 2/06/23, indicated prior to treatment initiation, 2 direct patient care employees were to perform a pre-treatment safety check which included verifying the “ ... prescribed dialyzer ... dialysate flow rate ... proper delivery of dialysate prescription ....” 3. During an observation on 7/19/24 beginning at 4:41 AM, Patient Care Technician (PCT) 5 was observed at Station 1 transferring Patient #46 from his/her wheelchair to the treatment chair. PCT 5 failed to lock the wheelchair in place prior to lifting the patient. A full body hammock - style Hoyer sling was used to transfer Patient. The technician failed to ensure the sling was in proper position, as the top of the sling was above Patient’s head and the bottom of the sling was at Patient’s buttocks. PCT 5 was the only staff member present in the station while Patient was being transferred from the wheelchair to the treatment chair. PCT 5 initiated Patient’s dialysis treatment at 4:52 AM and then asked other staff to complete a pre-treatment safety check. PCT 13 entered the station at 4:54 AM and performed the check. After performing the check, PCT 13 informed PCT 5 that Patient’s ultrafiltration goal needed to be adjusted. 4. During an observation on 7/19/24 beginning at 5:15 AM, PCT 20 initiated Patient #36’s dialysis treatment then asked other staff to complete a pre-treatment safety check. Registered Nurse (RN) 4 came to the station and performed the check at 5:16 AM. 5. During an observation on 7/19/24 beginning at 5:24 AM, PCT 5 initiated Patient #2’s dialysis treatment then asked other staff to complete a pre-treatment safety check. PCT 20 went to Station 4 and performed the check at 5:27 AM. During an interview with PCT 5 on 7/19/24 beginning at 6:18 AM, he reported “ideally” 2 staff members would be present for a patient transfer with a Hoyer lift. PCT 5 stated no other staff members were available to assist when he transferred Patient #46 as they were all “busy.” The technician reported the wheelchair should be locked when transferring a patient, however he did not lock the wheelchair when transferring Patient #46. PCT 5 reported Patient’s Hoyer sling was in a “bad” position because the top of the sling was “too high.” The technician reported the patient’s dialysis settings should be verified by 2 staff members prior to initiation of treatment, however this did not always happen, as staff had been pressured to ensure the treatments were started on time.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 42617 Based on observation, record review, and interview, the dialysis facility failed to accurately identify and assess in-center hemodialysis (ICHD) patients to ensure they received the correct dialysis treatment for 2 of 10 patients observed initiating treatment on 6/13/24 (Patients #30, 31). The severity of the findings evidenced the dialysis facility staff failed to conduct an accurate patient assessment, including patient identification, which led to 2 patients receiving incorrect dialysis treatment and medications. Therefore, Fresenius Medical Care Logansport was found out of compliance with 42 CFR 494.80 Patient assessment. Findings include: 1. The review of facility policy #25797 titled “Fresenius Kidney Care Patient Identification at the Dialysis Facility,” dated 7/03/23, indicated facility staff’s primary responsibilities in “all patient identification processes are: Correctly identifying patients before initiating dialysis or administering care to the patient ....” Upon a new patient’s admission to the facility, staff were to take “an unobstructed, vertically oriented photograph of the dialysis patient.” Patients were to be asked “to remove all articles of clothing that would obstruct a clear headshot portrait (i.e. bulky jackets, or other items of clothing that may obstruct the face) ....” Once the photograph was uploaded to the patient’s clinical record, it could be used “as an identifier for those patients who have been seen at the facility on multiple occasions and are well known to staff members at the dialysis facility.” If photographic identification was unavailable, staff were to use two patient identifiers, including “full name and date of birth to verify a patient’s identity prior to the administration of any dialysis care.” Staff who had not worked with the patient prior “must also confirm the identity with a staff member who is familiar with the patient prior to initiating treatment.” 2. The review of an ICHD treatment schedule for 6/13/24 evidenced Patient #31 was assigned to Station 1 with a start time of 5:00 AM and end time of 8:00 AM. Patient #30 was assigned to Station 2 with a start time of 5:45 AM and end time of 9:30 AM. 3. An observation of the ICHD treatment floor on 6/13/24 beginning at 4:30 AM evidenced the following: a. At 4:55 AM, Patient #30 walked from the scale to Station 1 with Registered Nurse (RN) 4. b. At 5:10 AM, Patient Care Technician (PCT) 8 initiated Patient #30’s dialysis treatment in Station 1. The dialysis machine was set to Patient #31’s profile and dialysis orders. c. At 5:42 AM, Patient #31 walked from the scale to Station 2 with PCT 8. d. At 5:56 AM, PCT 8 initiated Patient #31’s dialysis treatment in Station 2. The dialysis machine was set to Patient #30’s profile and dialysis orders. e. At 8:16 AM, Patient #30’s treatment was complete. PCT 8 began termination procedures. f. At 8:23 AM, Secretary 2 spoke with RN 4, gestured towards Station 2, and reported Patient #31’s family member was inquiring when Patient would be done with his/her treatment. RN reported Patient #31’s treatment was already complete, and Patient had left the facility. RN 4 gestured towards Station 2, where Patient #31 was sitting, and reported he/she was Patient #30. g. At 9:45 AM, Patient #31’s treatment was complete. PCT 8 began termination procedures. h. At 10:00 AM, PCT 1 informed RN 4 the patient in Station 2 was Patient #31, not Patient #30 as the nurse had previously stated. i. At 10:05 AM, PCT 8 obtained Patient #31’s post-treatment weight and Patient left the facility. Administrator identified him/her as Patient #31. PCT 8 reported Patient had been angrily speaking with him in Spanish when PCT removed Patient’s cannulation needles, but the employee could not make out what Patient was saying. PCT 8 reported the needle removal may have been painful and thought this was the reason Patient was upset. Administrator stated Patient’s family member was upset that Patient was leaving treatment late as he/she had an appointment at 10:00 AM. 4. The review of Patient #30’s clinical record evidenced a dialysis treatment order dated 3/14/24 which included a dialysate bath concentration of 2.0 milliequivalents per liter (mEq/L) potassium (K+) and 137 mEq/L sodium (Na+), blood flow rate (BFR) 350, and a run time of 3 hours 45 minutes. Patient’s Estimated Dry Weight (EDW, weight the patient was to be within 1 kilogram (kg) of at the end of dialysis treatment) was 59.5 kg. Patient had an arteriovenous fistula (AV fistula, a surgically created access site for dialysis) and 16-gauge (g) needles were to be used for cannulation. The record failed to evidence an order for a protein supplement to be administered during treatment. 3000 units Heparin (a blood thinner) was to be given at the beginning of treatment and 1500 units Heparin was to be given mid-treatment. The record evidenced on 6/13/24 at 5:00 AM, PCT 8 completed a “pre-treatment evaluation” of Patient #30, which included confirmation of Patient identity and dialysis orders. The technician cannulated Patient’s fistula with 15-g needles. The machine settings were verified by RN 4. Patient #30’s post-treatment weight at his/her last treatment (6/11/24) was 51.6 kg, and his/her pre-treatment weight on 6/13/24 was 60.3 kg. Patient’s treatment was documented as initiated at 5:15 AM by PCT 8. RN 4 documented a nursing assessment at 5:44 AM, noting she verified Patient’s machine settings, Patient’s weight gain between his/her last treatment and 6/13/24 was “high,” and staff had re-weighed Patient to verify the significant increase. During his/her treatment, Patient was dialyzed with a dialysate bath concentration of 3.0 mEq/L potassium and 137 mEq/L Na+, and BFR 450. At 8:32 AM, Patient was given 1 ounce (oz) of LiquaCel (an oral protein supplement) by RN 4. The record failed to evidence Heparin was administered during Patient’s treatment. The treatment ended at 8:14 AM with a total run time of 3 hours 1 minute. RN 4 documented a post-treatment evaluation at 8:14 AM, which indicated Patient was 7.1 kg above his/her EDW, and staff questioned whether this was due to a “scale error.” Patient was discharged from the facility. 5. The review of Patient #31’s clinical record evidenced a dialysis treatment order dated 3/09/24 which included a dialysate bath concentration of 3.0 mEq/L K+ and 137 mEq/L Na+, BFR 450, and a run time of 3 hours. Patient’s EDW was 51.5 kg. Patient had an AV fistula to the right upper arm and 15-g needles were to be used for cannulation. Patient was to be given 1 oz of LiquaCel by mouth during treatment. Patient did not have an order to administer Heparin during treatment. The record evidenced on 6/13/24 at 5:46 AM, PCT 8 completed a “pre-treatment evaluation” of Patient #31, which included confirmation of Patient identity and dialysis orders. The technician cannulated Patient’s fistula with 16-g needles. The machine settings were verified by PCT 10. Patient #31’s post-treatment weight at his/her last treatment (6/11/24) was 59.2 kg, and his/her pre-treatment weight on 6/13/24 was 53.3 kg. Patient’s treatment was documented as initiated at 5:56 AM by PCT 8. RN 4 documented a nurse assessment at 6:09 AM, noting she verified Patient’s machine settings, and Patient’s fluid removal goal was set to 500 milliliters (ml). The record failed to evidence the facility staff had assessed for causes of Patient’s significant decrease in weight between treatments. During his/her treatment, Patient was dialyzed with a dialysate bath concentration of 2.0 mEq/L K+ and 130 mEq/L Na+, and BFR 350. The record failed to evidence Patient’s ordered LiquaCel was administered. 3000 units of Heparin was administered at 5:56 AM by PCT 8 and 1500 units of Heparin was administered at 8:30 AM by PCT 8. Patient’s treatment ended at 9:46 AM, a total run time of 3 hours 50 minutes. RN 4 documented a post-treatment evaluation at 9:48 AM which indicated Patient was “under” his/her EDW at the end of treatment and the ordered EDW would be reassessed at Patient’s next treatment. The review of Patient #31’s laboratory results evidenced on 6/04/24, Patient’s sodium level was 138 mEq/L (normal range 136 - 145 mEq/L) and chloride level was 105 mEq/L (normal range 98 - 107 mEq/L). The review of laboratory results collected by Entity I, a local hospital, on 6/13/24 at 3:32 PM, indicated Patient’s sodium level was 131 mEq/L and chloride level was 89 mEq/L. 6. During an interview with PCT 8 on 6/13/24 beginning at 10:10 AM, he reported he verified both Patient #30 and #31’s identity by saying their name to the patient. PCT 8 reported both patients were Spanish-speaking and responded “yes” when PCT 8 said the name. The technician stated when he had gone to the lobby and called for Patient #30, Patient #31 had stood up and walked back to the treatment floor. PCT 8 reported he was not familiar with the patients as he was a float employee, and this was his first day working at the facility. 7. During an interview with RN 4 on 6/13/24 beginning at 10:35 AM, she reported she verified both Patient #30 and #31’s identity by saying their name to the patient. RN 4 reported both patients replied “yes” when the nurse said the name of the other patient. The dialysis machine had a small picture of the patient, but the photographs were “not clear.” RN 4 reported when she had gone to the lobby and called for Patient #31, both Patient #31 and Patient #30 were in the lobby, and Patient #30 answered to Patient #31’s name. RN 4 reported she was not familiar with the patients as she was a contracted employee, and this was her second day working at the facility. 8. During an interview with Medical Director on 6/13/24 beginning at 12:02 PM, he reported he was notified by the facility of Patient #30 and #31 receiving the incorrect treatment. The physician reported the error likely occurred due to both patients having a language barrier and staff working were both new, so they were not familiar with the patients. 9. During an interview with Administrator and Alternate Administrator on 6/14/24 beginning at 9:15 AM, Administrator reported the facility staff had reviewed Patients #30 and #31’s clinical record photographs after the incorrect treatment error had been discovered. Administrator reported the photographs did not evidence a clear, unobstructed view of the patients due to clothing and/or Personal Protective Equipment (PPE) worn.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 42617 Based on observation, policy review, record review, and interview, the dialysis facility failed to maintain a sanitary environment specific to the mixing and storage of bleach solutions used for disinfection of the dialysis stations and pressure clamps (see Tag V111); failed to ensure all staff followed hand hygiene and personal protective equipment policies and best practices (see Tag V113); failed to ensure staff completed disinfection of dialysis stations according to infection control policies and best practice and failed to ensure staff followed bed bug mitigation policies specific to cleaning of the station after treatment (see Tag V122); failed to perform monthly infection prevention audits of in-center hemodialysis activities (see Tag V142); and failed to ensure all staff performed appropriate infection control measures when administering dialysis through a central venous catheter (see Tag V147). The cumulative effect of these systemic issues resulted in the facility being unable to provide adequate infection control measures. Therefore, Fresenius Medical Care Logansport was found out of compliance with Conditions of Coverage 494.30 Infection control.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to ensure a test for total chlorine of the in-center hemodialysis (ICHD) product water was performed and documented, according to facility policy, prior to the first patient treatment and every 4 hours afterwards (see tag V196). The Administrator and Alternate Administrator were notified on 5/30/24 at 12:00 PM of an Immediate Jeopardy at 42 CFR 494.40 Water and dialysate quality. The Immediate Jeopardy was identified as beginning on 05/03/24. The immediacy was abated effective 06/04/24. The cumulative effect of these systemic issues resulted resulted in the facility being unable to ensure the quality of its product water. Therefore, Fresenius Medical Care Logansport was found of out of compliance with Condition for Compliance 42 CFR 494.40 Water and dialysate quality.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 42617 Based on observation, record review and interview, the dialysis facility failed to ensure the prescribed blood flow rate, dialysate flow rate, and treatment time were provided to the hemodialysis patient as ordered (see Tag V544). Based on record review and interview, the dialysis facility failed to ensure the in-center hemodialysis (ICHD) clinic opened and all patients were started on their treatments timely and could receive their dialysis treatement according to the plan of care (see Tag V541); failed to ensure the Registered Nurse (RN) assessment was completed within 1 hour of the patient hemodialysis start time and was repeated at the end of treatment if the patient exhibited symptoms of fluid overload , failed to address post-treatment orthostatic hypotension, and failed to ensure medications were administered as ordered to treat low blood pressure (see Tag V543); failed to administer medications for the treatment of anemia according to the patient’s plan of care (see Tag V544); and failed to develop and implement plans for pursing kidney transplantation (see Tag V554). The scope and severity of these systemic issues evidenced Fresenius Medical Care Logansport failed to develop and implement an individualized plan of care. Therefore, the dialysis facility was found to be out of compliance with 42 CFR 494.90. On 6/04/24 at 3:45 PM, Alternate Administrator was notified of an Immediate Jeopardy at 42 CFR 494.90 Patient plan of care. The Immediate Jeopardy was identified as beginning on 4/09/24. The immediacy was not abated prior to survey exit on 6/06/24.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to take actions which resulted in performance improvement specific to late total chlorine testing of the in-center hemodialysis (ICHD) product water (see Tag V638). The severity of this deficiency evidenced Fresenius Medical Care Logansport failed to maintain an effective Quality Assessment and Performance Improvement program which focused on indicators related to the prevention and reduction of medical errors. Therefore, the dialysis facility was found out of compliance with 42 CFR 494.110 Quality assessment and performance improvement.”

“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: 42617 Based on observation, policy review, and interview, the dialysis facility failed to ensure emergency medications were available on site per facility policy for 1 of 1 observation of the facility’s emergency code cart, which had the potential to affect 61 active in-center hemodialysis patients. Findings include: 1. A review of facility policy #46865 titled “Emergency Medications, Equipment and Supplies,” dated 5/01/23, indicated the facility had “identified a reasonable selection of medications to manage emergency situations such as ... cardiac arrest pending arrival of EMS ....” The policy indicated the selected medications “must be maintained at the dialysis facility” and included sodium bicarbonate (medication used for the emergency treatment of cardiac arrest). 2. During an observation of the facility’s emergency code cart on 6/06/24 at 5:28 AM, the cart failed to evidence a supply of sodium bicarbonate. During an interview with Registered Nurse (RN) 2 on 6/06/24 at 5:53 AM, the nurse reported the facility’s supply of sodium bicarbonate should be stored within the emergency code cart. RN 2 reported she was unable to find a supply of sodium bicarbonate at the facility. During an interview with Medical Director on 6/06/24 beginning at 12:30 PM, the physician reported emergency medications kept on site were reviewed by facility staff “quarterly.” Medical Director was unaware the facility did not have a supply of sodium bicarbonate on site.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 42617 Based on record review, policy review, and interview, the dialysis facility failed to provide appropriate orientation and training to patients specific to performing emergency disconnection from the dialysis machine for 1 of 1 patient interviewed who had begun receiving dialysis at the facility within the previous 1 week (Patient 11). Findings include: 1. The review of facility policy titled “Guidelines for Emergency Preparedness,” dated 4/05/21, indicated topics the facility “must” educate patients on included but were not limited to “emergency disconnection procedures.” The policy also indicated if a facility activated its emergency preparedness plan, an “after-action review” must be completed. 2. The review of a facility document titled “Disaster Facility Incident: After Action Review / Improvement Plan” indicated on 12/13/23, the facility activated its emergency preparedness plan due to a “general fire alarm.” When the fire alarm was activated, patients were taken off dialysis treatment and evacuated from the dialysis building until the local fire department cleared the building. The after-action review indicated opportunities the facility identified for improvement included “new patients were missing initial education.” An “improvement plan” indicated new patients would be provided emergency evacuation training on their first day of treatment by the staff Registered Nurse. 3. The review of Patient #11’s clinical record failed to evidence documentation of education provided to Patient related to emergency disconnect procedures. During an interview with Patient #11 on 5/29/24 beginning at 5:24 PM, he/she reported they were on their second dialysis treatment day at the facility. Patient reported he/she had not received any education on emergency disconnection procedures from the facility staff. During an interview with Alternate Administrator on 6/06/24 beginning at 3:20 PM, she reported Patient #11 was admitted to the dialysis facility on 5/27/24 and had not yet received training on emergency disconnection procedures.”

“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 maintain a sanitary environment specific to the mixing and storage of bleach solutions used for disinfection of the dialysis stations and pressure clamps, for 1 of 2 observations of bleach solution mixing and 1 of 4 days of in-center (ICHD) hemodialysis observations, which had the potential to affect 61 active ICHD patients. Findings include: 1. The review of facility policy #47806 titled “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, indicated bleach solution should be stored in a covered container “to prevent disintegration of the chemical (sodium hypochlorite) when exposed to sunlight and air.” Clamps used to maintain pressure at a dialysis access site should be disinfected in a container with 1:100 concentration bleach solution (1-part bleach to 100-parts water). 2. During an observation of ICHD bleach mixing on 6/04/24 beginning at 3:50 AM, a sign was observed by the bleach preparation station which indicated 1:10 concentration bleach solution was to be prepared by mixing 100 milliliters (mls) bleach and 900 mls water. Patient Care Technician (PCT) 2 was observed preparing 1:10 concentration bleach solution and transferring it into 2 containers, 1 of which was unmarked. PCT 2 then mixed 20 mls bleach with 1000 mls water for a 1-part bleach to 10-parts water (1:10 concentration) solution. PCT 2 placed the solution in an unmarked container. During an interview with PCT 2 on 6/04/24 at 3:56 AM, she reported 1:10 concentration bleach solution was made with 100 mls bleach and 1000 mls water. The measuring container used by PCT 2 to measure bleach was marked in increments of 10 milliliters. PCT 2 pointed to the 2nd mark on the container, indicating bleach had been measured to the 20-ml line. 3. An observation on the ICHD treatment floor on 6/04/24 evidenced the following: a. At 9:36 AM, 2 containers with 1:100 bleach concentration solution were observed open. One of the containers was used to disinfect pressure clamps. b. At 9:53 AM, PCT 4 removed pressure clamps from Station 10 after a patient had completed treatment. PCT 4 placed the clamps in an open bleach container. PCT 4 failed to close the container after placing the clamps into the solution. c. At 12:19 PM, 1 container with 1:100 bleach concentration solution was observed open. The container had pressure clamps soaking in the bleach solution. 4. During an interview with PCT 5 on 6/04/24 beginning at 12:24 PM, he incorrectly identified the concentration of bleach solution in the unmarked containers previously prepared by PCT 2. The technician reported bleach solution should be stored in closed containers.”

“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 all staff followed hand hygiene and personal protective equipment (PPE) policies and best practices for 3 of 4 days of in-center hemodialysis treatment observations (Patient Care Technician (PCT) 3, 4, 5, 9, Registered Nurse (RN) 1. Findings include: 1. The review of facility policy #47664 titled “Hand Hygiene,” dated 11/06/23, indicated staff should perform hand hygiene “before and after direct contact with patients ... entering and leaving the treatment area ... immediately after removing gloves ... after contact with other objects within the patient station or treatment space ....” When staff performed hand hygiene with hand sanitizer, the staff member was to rub their hands together “until hands are dry,” which “allows adequate contact time to kill germs, allows alcohol to evaporate, and prevents risk of igniting flames due to alcohol’s flammable properties.” 2. During an observation on 6/04/24 beginning at 4:58 AM, PCT 3 was in Station 7 with Patient #14 preparing to initiate dialysis. PCT 3 left the station, removed her gloves, and walked to a coat hanger where staff stored used personal protective equipment (PPE) and stethoscopes. PCT 3 picked a stethoscope from multiple stethoscopes entwined on 1 hanger, returned to Station 7, and donned new gloves. PCT 3 failed to perform hand hygiene after removing her gloves and prior to re-entering Station 7. 3. During an observation on 6/04/24 beginning at 5:22 AM, PCT 3 was observed in Station 8 disinfecting Patient #15’s central venous catheter (CVC) then changed her gloves. PCT 3 failed to perform hand hygiene in between the glove change. During an interview with PCT 3 on 6/04/24 beginning at 6:16 AM, PCT 3 reported she should perform hand hygiene after removing gloves and in between glove changes. 4. During an observation on 6/04/24 beginning at 6:35 AM, PCT 4 was observed entering Station 10 while Patient #19 was on dialysis treatment. PCT 4 donned a glove to her right hand only and her left hand was in her pant pocket. The technician left the station, obtained a bag of saline solution from a supply cart, and donned a glove to her left hand. PCT 4 re-entered Station 10 and connected the saline bag to Patient’s dialysis tubing. PCT 4 failed to perform hand hygiene after leaving the station and prior to donning a glove to her left hand. 5. During an observation on 6/04/24 beginning at 9:53 AM, PCT 4 was observed cleaning Station 10 after patient use. During the cleaning, PCT 4 failed to perform hand hygiene in between 2 glove changes. During an interview with PCT 4 on 6/04/24 beginning at 6:41 AM, she reported hand hygiene should be performed whenever gloves were removed. 6. During an observation on 6/04/24 beginning at 10:17 AM, PCT 3 was observed performing hand hygiene with hand sanitizer. After applying the hand sanitizer, PCT 3 waved her hands to let the sanitizer dry. During an interview with PCT 3 on 6/06/24 beginning at 2:37 PM, she reported when performing hand hygiene with hand santizer, hands should be rubbed together until dry. 7. During an observation on 6/06/24 beginning at 6:15 AM, PCT 9 was observed entering Station 1 without a gown or face shield while Patient #33 was receiving treatment. PCT 9 donned a glove to his right hand only. While in the station, PCT 9 touched both Patient and the dialysis equipment with his ungloved hand. During an interview with PCT 9 on 6/06/24 beginning at 2:31 PM, he reported PPE to be worn when in a dialysis station included a gown and face shield. 8. During an observation on 6/06/24 beginning at 10:15 AM, PCT 5 was observed cleaning a station after patient use. RN 2 called PCT 5 over to Station #5 where Patient #34 was dialyzing. PCT 5 removed his gloves, readjusted his clothing, and donned new gloves as he entered Station 5. The technician failed to perform hand hygiene in between glove changes. During an interview with PCT 5 on 6/06/24 beginning at 2:29 PM, he reported hand hygiene should be performed when changing gloves and going from 1 station to another. 47022 9. During an observation on 6/05/2024 beginning at 1:45 PM, RN 1 donned gloves to pass oral medication to Patient #23 in Station 3. RN 1 removed her gloves and donned new gloves, failing to perform hand hygiene in between the glove change. RN 1 then verified Patient’s dialysis prescription by touching the computer screen for Station 3. RN 1 moved from Station 3 to Station 5 (Patient #24) and touched Station 5’s computer screen, failing to change gloves and perform hand hygiene. RN 1 moved to Station 10 (Patient #10), touched the computer screen, then changed her gloves, failing to perform hand hygiene in between the glove change. RN 1 repeated this for 2 additional stations (Station 9 with Patient #25, Station 11 with Patient #32), failing to perform hand hygiene when changing gloves in between stations. During an interview with RN 1 on 06/05/2024 beginning at 1:45 PM, RN 1 reported hands should be sanitized in between changing gloves.”

“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 staff completed disinfection of dialysis stations according to infection control policies and best practice in 4 of 4 observations of staff disinfecting a dialysis station (Patient Care Technicians 1, 3, 4, 5) and failed to ensure staff followed bed bug mitigation policies specific to cleaning of the station after treatment for 1 of 1 patients identified as having bed bugs (Patient #15). Findings include: 1. A review of facility policy #47806 titled “Cleaning and Disinfecting the Dialysis Station,” dated 09/05/23, indicated after each in-center hemodialysis treatment, “all work surfaces” were to be cleaned and disinfected with 1:100 concentration bleach solution. When disinfecting the treatment chair, staff should open the side panels to ensure all surfaces of the chair were accessible. Once disinfected with the bleach solution, staff should allow all surfaces to air dry. The policy also indicated “to prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station and set up for the next patient.” 2. A review of facility policy titled “Bed Bug Control Policy,” revised 12/22, indicated when a patient was identified as having bed bugs, the facility “must take immediate action to mitigate the risk of exposure to the clinic, other patients, and staff.” The policy indicated after the patient with bed bugs had completed ICHD treatment, staff was to use a handheld steamer “to steam the chair that the patient sat in. This should kill any bugs or eggs that may be present.” 3. During an observation on 5/29/24 beginning at 9:26 AM, PCT 1 was observed disinfecting Station 9 after patient use. Patient Care Technician (PCT) 1 wiped the treatment chair with gauze soaked in a bleach solution, laid a dirty blood pressure cuff on the chair while it was still visibly wet from the bleach solution, and held the cuff against the chair to wipe each side. 4. A review of the ICHD treatment schedule for 6/04/24 evidenced Patient #15 had previously been identified as having bed bugs. PCT 3 and Registered Nurse (RN) 1 were assigned to Patient #15. During an ICHD treatment floor observation beginning at 5:14 AM, Patient #15 was observed receiving dialysis treatment. During an interview with PCT 3 on 6/04/24 beginning at 10:37 AM, she confirmed Patient #15 had previously been identified as having bed bugs. PCT 3 reported after Patient #15 had completed his/her treatment and left the station, PCT 3 had not disinfected the treatment chair using a handheld steamer prior to a new patient using the station. PCT 3 stated the clinic did not have a handheld steamer available. During an interview with RN 1 and Alternate Administrator on 6/04/24 beginning at 2:10 PM, RN 1 reported the facility did have a handheld steamer. A handheld steamer was then observed in a supply room by the treatment floor. 5. During an observation on 6/04/24 beginning at 9:53 AM, PCT 4 was observed disinfecting Station 10 after patient use. PCT 4 used the same bleach-soaked gauze pad to clean both the dialysis machine and treatment chair, failed to open the chair’s side panels to disinfect all surfaces, and failed to disinfect the counter directly behind the station. PCT 4 then laid new supplies on the treatment chair’s side table while it was visibly wet with bleach solution. The supplies were to be used for the next patient’s treatment. During an interview with PCT 4 on 6/04/24 beginning at 10:53 AM, she reported when disinfecting a treatment station’s chair, a new bleach-soaked gauze pad should be used, and the side panels should be opened to wipe down all surfaces. PCT 4 stated she did not clean the counter behind the treatment station. 6. During an observation on 6/04/24 beginning at 10:17 AM, PCT 3 was observed disinfecting Station 7 after patient use. The technician opened the treatment chair’s side panels, wiped them with bleach-soaked gauze pads, then immediately shut them while they were visibly wet with bleach solution. After disinfecting the station, PCT 3 laid new supplies on the treatment chair and began to set up the machine for the next patient while the station surfaces were still visibly wet with bleach solution. During an interview with PCT 3 on 6/04/24 beginning at 3:40 PM, she reported when disinfecting a treatment chair, the side panels should remain open until the bleach solution had dried. PCT 3 also reported staff should wait until the bleach solution had dried across all surfaces of the station prior to preparing the station for the next patient treatment. 7. During an observation on 6/06/24 beginning at 9:33 AM, Patient #17 was observed in Station 7 holding pressure to his/her fistula sites after the access needles had been removed. PCT 5 was observed cleaning the station’s machine while Patient was sitting in the treatment chair holding pressure to the fistula sites.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to perform monthly infection prevention audits of in-center hemodialysis (ICHD) activities for 6 of 11 months between July 2023 - May 2024, which had the potential to affect 61 active ICHD patients. Findings include: 1. The review of facility policy #25799 titled “Quality Assessment and Performance Improvement [QAPI],” dated 5/02/22, indicated the charge nurse’s QAPI responsibilities included but were not limited to “measuring, analyzing, and tracking quality indicators.” QAPI meetings were to be held monthly and indicators to be reviewed at each meeting included but were not limited to “infection surveillance.” 2. The review of a facility document titled “Clinic Audit Checklist” evidenced between 7/01/23 - 6/05/24, the facility failed to perform and document monthly infection prevention audits of ICHD activities, including disinfection of the dialysis station and isolation practices, for July 2023, August 2023, October 2023, November 2023, December 2023, and March 2024. During an interview with Alternate Administrator on 6/06/24 beginning at 3:20 PM, she reported the facility did not have any further policies and procedures related to infection prevention audits. When queried on the reason the infection prevention audits had not been performed for 6 of the 11 previous months, Alternate Administrator reported the facility had not had a charge nurse until 5/29/24 and Administrator was new to the role.”

“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 all staff performed appropriate infection control measures when administering dialysis through a central venous catheter (CVC) for 2 of 3 observations of staff performing CVC exit site care (Patient Care Technician (PCT) 4, 9) and 2 of 2 observations of staff terminating dialysis for patients with a CVC (PCT 2, 4). Findings include: 1. The review of facility procedure #45664 titled “Central Venous Catheter [a long catheter placed in a large vein for dialysis] Dressing Change,” dated 5/06/24, indicated staff was to clean the CVC exit site with an antiseptic for 30 seconds, allow the area to dry, then apply a new dressing. 2. The review of facility policy #45640 titled “Termination of Treatment using a Central Venous Catheter ...,” dated 2/07/22, indicated prior to disconnecting a patient from the dialysis tubing, staff should “ensure that a clean under pad is below the catheter limbs to protect the work area and the clothing.” 3. During an observation on 6/04/24 beginning at 5:25 AM, PCT 4 was in Station 10 performing CVC site care on Patient #19. PCT 4 cleaned the CVC exit site with an antiseptic for 24 seconds. During an interview with PCT 4 on 6/04/24 beginning at 6:41 AM, she reported the CVC exit site should be cleaned for 60 seconds with an antiseptic. 4. During an observation on 6/04/24 beginning at 9:47 AM, PCT 4 was in Station 10 terminating Patient #19’s dialysis. PCT 4 failed to apply a clean under pad below the CVC catheter limbs prior to disconnecting the dialysis tubing. During an interview with PCT 4 on 6/04/24 beginning at 10:53 AM, she reported the under pad below a CVC catheter’s limbs did not need to be changed prior to disconnecting the dialysis tubing. 5. During an observation on 6/04/24 beginning at 12:47 PM, PCT 2 was in Station 2 terminating Patient #3’s dialysis. PCT 2 failed to apply a clean under pad below the CVC catheter limbs prior to disconnecting the dialysis tubing. During an interview with PCT 2 on 6/05/24 beginning at 6:26 AM, she reported a clean under pad should be applied below a CVC catheter’s limbs prior to disconnecting the dialysis tubing. 6. During an observation on 6/06/24 beginning at 9:47 AM, PCT 9 was observed in Station 3 performing CVC site care to Patient #20. After PCT 9 disinfected the exit site area, Patient’s t-shirt moved on to the “clean” site. PCT 9 failed to disinfect the site again prior to applying a dressing. The dressing covered the area that had contact with Patient’s clothing. During an interview with PCT 5 on 6/06/24 beginning at 2:29 PM, he reported if a patient’s clothing touched the CVC exit site area after disinfection, the area should be cleaned again prior to applying a dressing.”

“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: 42617 Based on record review and interview, the dialysis facility failed to ensure a test for total chlorine (TCL) of the in-center hemodialysis (ICHD) product water was performed and documented prior to the first patient treatment and every 4 hours afterwards, which had the potential to affect 61 active ICHD patients. Findings include: 1. A review of facility policy #1457 titled “Carbon Filtration Monitoring of Central Water Systems ...,” dated 9/05/23, indicated the facility’s product water would be tested for chlorine levels “prior to the initiation of the first patient treatment of the day and at a minimum of every four hours ....” 2. A review of the facility’s ICHD total chlorine testing logs for 5/01/24 - 5/29/24 evidenced the following: a. On 5/03/24, one TCL test was logged at 7:40 PM. The log failed to evidence previous testing had been performed that day. A review of the first patient treatment initiated on 5/03/24 indicated Patient #28 was the first patient treatment initiated at 5:07 AM. b. On 5/06/24, the first TCL test was logged at 8:05 AM. The log failed to evidence a TCL test was performed prior to patient treatment beginning. A review of the first patient treatment time initiated on 5/06/23 indicated Patient #4 was the first patient treatment initiated at 4:59 AM. c. On 5/07/24, the first TCL test was logged at 7:42 AM. A review of treatment records for 5/07/24 indicated Patient #18 was the first patient treatment initiated at 5:08 AM. d. On 5/10/24, a TCL test was logged at 11:52 AM. The next test was not logged as completed until 4:23 PM, which was 4 hours and 31 minutes in between tests. e. On 5/13/24, the first TCL test was logged at 8:13 AM by Registered Nurse (RN) 2 and Patient Care Technician (PCT) 6. The log included a note which stated the first test “was not late,” however the log indicated this was the first TCL test documented for 5/13/24. A review of treatment records for 5/13/24 indicated Patient #29 was the first patient treatment initiated at 4:52 AM. The next TCL test was logged at 12:12 PM. f. On 5/14/24, the first TCL test was logged at 8:02 AM by RN 2 and PCT 6. The log included a note which indicated “first [test was performed] in AM prior to first patient,” however the log failed to evidence a TCL test documented prior to 8:02 AM. A review of treatment records for 5/14/24 indicated Patient #18 was the first patient treatment initiated at 4:58 AM. The next TCL test was logged at 12:16 PM. g. On 5/15/24, the first TCL test was logged at 8:26 AM. A review of treatment records indicated Patient #29 was the first patient treatment initiated at 4:45 AM. h. On 5/21/24, a TCL test was logged at 9:40 AM by RN 3 and PCT 7. The log included a note which indicated the test was entered late “due to internet outage.” The log indicated the next TCL test was not documented until 2:00 PM, which was 4 hours 20 minutes after the previous documented test. i. On 5/23/24, a TCL test was logged at 8:00 AM. A review of treatment records indicated Patient #18 was the first patient treatment initiated at 4:44 AM. TCL testing was then performed at 11:53 AM and 4:00 PM, a difference of 4 hours and 7 minutes. j. On 5/25/25, a TCL test was logged at 7:24 AM. A review of treatment records indicated Patient #18 was the first patient treatment initiated at 4:40 AM. During an interview with Biomed Technician 1 on 5/29/24 beginning at 4:39 PM, he reported the facility’s product water should be tested to ensure total chlorine levels were below actionable levels prior to the initiation of the first ICHD patient treatment and every 4 hours subsequently. Biomed Technician 1 reported he reviewed the TCL logs monthly for compliance with this requirement. The employee stated he also received email notification when a TCL test was missed or performed late, however it was the responsibility of Administrator to follow-up with direct care staff regarding the missed test(s). During an interview with Administrator and Alternate Administrator on 5/29/24 beginning at 4:50 PM, Administrator reported she had received email notification when TCL tests were missed or performed late, however she was new to the role and was unsure how to address. Alternate Administrator reported the facility had been staffed by a rotation of travel nurses and technicians which resulted in difficulty ensuring the TCL testing was being performed according to facility policy.”

“PR-PRIVACY & CONFIDENTIALITY-TREATMENT CFR(s): 494.70(a)(3) The patient has the right to- (3) Privacy and confidentiality in all aspects of treatment; This Standard is not met as evidenced by: 42617 Based on observation, policy review, and interview, the dialysis facility failed to protect the patient’s right to privacy during verbal interactions between staff for 1 of 2 patients observed being re-weighed prior to initiation of treatment (Patient #35). Findings include: 1. A review of facility policy titled “Patient Rights and Responsibilities,” dated 4/04/12, indicated the patient had the right to “privacy and confidentiality in all aspects of treatment.” 2. During an observation of the in-center hemodialysis treatment floor on 6/04/24 beginning at 10:07 AM, Patient #35 was observed in Station 11 with Patient Care Technicians (PCT) 2 and PCT 4. Patient #35 had been weighed prior to arriving at the Station, however there was a large variance in Patient’s current and last weights. PCT 2 walked with Patient #35 back to the scale on the other side of treatment floor while PCT 4 remained in Station 11. After Patient’s weight was obtained a second time, PCT 2 yelled out Patient’s weight twice to PCT 4 while the technician and Patient were walking back to the station. During an interview with PCT 2 on 6/05/24 beginning at 4:06 PM, the technician reported she should protect patient’s privacy with his/her weight by refraining from yelling the weight out while on the treatment floor.”

“PR-INFORMED OF INTERNAL GRIEVANCE PROCESS CFR(s): 494.70(a)(14) The patient has the right to- (14) Be informed of the facility’s internal grievance process; This Standard is not met as evidenced by: 42617 Based on record review and interview, the facility failed to follow its internal grievance policy and procedures specific to the documentation, investigation, and resolution of grievances filed related to concerns with care provided by facility staff for 3 of 4 former employees (Former Employee E, Former Employee F, Former Employee H). Findings include: 1. A review of facility procedure titled “Patient Grievance Procedure,” dated 4/04/13, indicated when the facility received a grievance from a patient and/or patient representative, facility staff was to meet with the complainant within 72 hours “to gather information” and begin completing the facility’s grievance log. The clinic manager was to meet with the complainant within 5 business days “to acknowledge, investigate, and address the grievance.” The medical social worker (MSW) “or other staff” were able to “assist in assessing and resolving patient grievances.” The facility staff was to report the grievance’s resolution to the complainant once it was attained. Documentation of the grievance was to include but was not limited to “nature of the grievance ... findings of the investigation ... resolution and any corrective actions taken ....” 2. During an interview with MSW 1 on 5/29/24 beginning at 1:53 PM, the social worker reported she had been responsible for grievance documentation, investigation, reporting of the resolution to the complainant, and reporting on all patient grievances to the facility’s Quality Assessment and Performance Improvement (QAPI) committee. The facility’s grievance log for all grievances received between 5/29/23 - 5/29/24 was reviewed with MSW 1 during the 5/29/24 interview and evidenced the following: a. A grievance was logged on 4/29/24 by MSW 1 involving Patient #34. The “Grievance Details” indicated “[Former Employee E] wasn’t listening to [Patient #34]’s request for amount of fluid” to be removed. The log failed to evidence the investigation performed, including findings, and the grievance resolution. During the 5/29/24 interview with MSW 1, she reported the facility’s resolution to the grievance was that Former Employee E was no longer working at the facility due to multiple grievances filed. No further actions were taken regarding this grievance. b. A grievance was logged on 4/19/24 by MSW 1 involving Patient #36. The “Grievance Details” indicated “[Patient #36’s family member] called.” The log failed to evidence the nature of the grievance, investigation performed, including findings of the investigation, and grievance resolution. During the 5/29/24 interview with MSW 1, she reported Patient #36 spoke very limited English, so Patient’s family member would translate. MSW 1 stated Patient’s family member called the clinic to speak with MSW 1, however Former Employee H refused to transfer the family member to MSW 1. Once the family member finally spoke with MSW 1, he/she requested to speak only with the social worker going forward. When queried on the resolution of the grievance, MSW 1 reported Former Employee H was already scheduled to transfer to a new clinic, and the family member was to request to speak with the social worker when he/she calls. No further actions were taken regarding this grievance. c. A grievance was logged on 4/19/24 by MSW 1 involving Patient #8. The “Grievance Details” indicated “[Patient #8] voiced concerns about [unnamed employee] not taking proper care of [patients] and infiltrating fistulas. The log failed to evidence further details regarding the complaint, including the investigation performed, findings of the investigation, and grievance resolution. During the 5/29/24 interview with MSW 1, she reported the employee named by Patient #8 was Former Employee E. Patient #8 had reportedly observed another patient’s fistula site get infiltrated (needle dislodged, causing injury) by the former employee, and had asked MSW 1 how many patients were going to get hurt before the staff in question was removed? The social worker reported the grievances against Former Employee E were discussed in the facility’s QAPI committee and the resolution was Former Employee was no longer working at the facility. MSW 1 reported she typically documented grievance findings and resolution once they were discussed in QAPI. She was unsure why the grievance did not have documented investigation findings nor a grievance resolution. d. A grievance entry was logged on 8/18/24 by MSW 1 which indicated grievances had been made by 6 patients (Patient #13, 34, 37, 38, 39, 40) against an unnamed employee between 8/11/23 - 8/18/23. MSW 1 reported the person named by all patients was Former Employee F. The grievances made against the staff member included but were not limited to - i. Patient #34 reported Former Employee F removed too much fluid during Patient’s dialysis treatment, despite Patient, the physician, and a Patient Care Technician (PCT) agreeing to a less aggressive amount of fluid removal. Patient stated he/she felt so weak after the treatment that they could not move or get out of bed until several days later. Patient reported he/she and “patients in the lobby have been discussing how horrible they have felt lately,” and Patient was below his/her Estimated Dry Weight prior to treatment at the time of the grievance report. ii. Patient #13 reported he/she observed Patient #37 needing assistance from Former Employee F while in the lobby. The employee reportedly said “[you’ll] do it on my time ...” After speaking with the patient in need, Patient #13 rang the doorbell in the lobby and Former Employee F opened the door to the treatment floor. Former Employee F stated “What? Are you disrespecting me ... Get out of here and out of my face” to Patient #13. The employee told Patient #13 he/she was “disrespecting” the employee then shut the treatment door in Patient’s face. Patient #13 reported at his/her next dialysis treatment, Former Employe F was so slow initiating Patient’s dialysis treatment it led to Patient’s treatment time being shortened. The log indicated MSW 1 spoke with Former Employee G, a previous interim administrator, “about the situation involving” Former Employee F. The interim administrator had reported Former Employee F “would not be returning to the clinic.” The complaint log failed to evidence the facility implemented measures to ensure all patients were treated with dignity and respect. During the 5/29/24 interview with MSW 1, she reported the multiple complaints made against Former Employee F were resolved by ensuring the former employee did not return to work at the facility. MSW 1 failed to evidence further interventions were performed related to grievances received. 3. During an interview with Medical Director on 5/30/24 beginning at 12:56 PM, he reported the facility had recently noted an increase in patient dissatisfaction and grievances filed which were “mostly staffing” related. Medical Director reported all grievances were discussed during the facility’s monthly QAPI meetings, however the facility had difficulty resolving the grievances, as most were regarding care provided by travel staff that was no longer working at the clinic. Medical Director said the facility would “give feedback” to the employees named in grievances and/or other facility staff when they were able, however soon after the re-education, the staff would be gone, and new staff would arrive.”

“POC-GOALS=COMMUNITY-BASED STANDARDS CFR(s): 494.90 The interdisciplinary team as defined at §494.80 must develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and must include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care must be consistent with current evidence-based professionally-accepted clinical practice standards. This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to ensure the in-center hemodialysis (ICHD) clinic opened and all patients were started on their treatments timely and could receive their dialysis treatement according to the plan of care on 4/09/24 and for 7 of 27 treatment days in May 2024, which resulted in 4 patients on 4/09/24 1st treatment shift not receiving treatment (Patients #5, 16, 17, 18), 1 patient being hospitalized (Patient #5), 5 of 16 patients dialyzed on 4/09/24 having a shortened treatment (Patients #15, 21, 22, 26, and 27), and had the potential to affect 61 active ICHD patients. Findings include: 1. During an interview with Administrator on 6/03/24 beginning at 10:32 AM, she reported treatments which began 20 minutes or more after the scheduled start time were considered “late.” 2. A list of missed ICHD treatments on 4/09/24 evidenced 4 patients scheduled for the facility’s 1st treatment shift had missed treatments on 4/09/24 - Patients #5, 16, 17, and 18. 3. The review of Patient #5’s medical record indicated Patient was to receive ICHD treatments 3 times a week and his/her Estimated Dry Weight (a physician-ordered weight the patient would be at without any extra fluid, which the patient was to within 1 kilogram (kg) by the end of dialysis treatment) was 59.4 kg. The record evidenced Patient received his/her dialysis treatment on 4/6/24 and their post-treatment weight was 60.8 kg. Patient was absent for his/her dialysis treatments on 4/09/24 and 4/11/24. Administrative Assistant (AA) 1 documented Patient’s reason for missed treatment on 4/09/24 was “Patient Refused to Attend Treatment” and on 4/11/24 was due to hospitalization. The record evidenced Patient was hospitalized at Entity A from 4/10/24 - 4/11/24 for “severe, gradually worsening abdominal pain, intermittent bloating, nausea, vomiting and diarrhea, and [shortness of breath].” The review of Patient #5’s hospital records from Entity A indicated Patient presented to the entity’s emergency department on 4/10/24 with symptoms including but not limited to shortness of breath “for the past few days” and chest pain which had started earlier that day. Patient reported he/she missed their dialysis treatment on 4/09/24 “due to issues with the dialysis center” and had not dialyzed in 4 days. Patient’s presenting weight was 65.6 kg, which was 6.2 kg above Patient’s EDW, and his/her potassium level was 5.9 (normal range 3.5 - 5.5). Patient was diagnosed with congestive heart failure and received 2 dialysis treatments while hospitalized. Patient’s chest pain resolved after receiving dialysis treatment. Patient was also diagnosed with ascites (fluid buildup in the abdomen) and had a paracentesis (surgical procedure which removes from the abdomen). Patient was discharged from Entity A on 4/11/24. During an interview with Alternate Administrator on 6/03/24 beginning at 3:44 PM, she reported the ICHD clinic opened late on 4/09/24 due to having no scheduled staff competency checked to perform opening water treatment procedures. Alternate Administrator 1 reported she began tracking which staff had been competency checked for opening and closing water treatment procedures and comparing with staff schedules to ensure there was at least 1 scheduled staff member who could perform the water treatment procedures. During an interview with Patient #5 on 6/04/24 beginning at 8:18 AM, Patient reported prior to his/her hospitalization at Entity A on 4/10/24 - 4/11/24, he/she had not received dialysis on 4/09/24 due to the clinic not being opened. Patient reported staff had advised him/her to go home due to a facility “electrical” issue. Patient reported facility staff did not advise Patient to return later nor did the facility staff contact Patient later to attempt to reschedule treatment. 4. The review of the facility’s treatment schedule for 4/09/24 evidenced Patient #16 was scheduled to begin treatment at 4:40 AM. Patient’s medical record indicated he/she missed their treatment on 4/09/24. AA 1 documented Patient’s reason for missed treatment was “Patient Refused to Attend Treatment.” The record evidenced at Patient’s next scheduled treatment on 4/11/24, his/her pre-treatment weight was 119.4 kg, which was 3.1 kg above Patient’s EDW of 116.3 kg. During an interview with Patient #16 on 6/04/24 beginning at 7:43 AM, Patient reported he/she was started late on treatment for “70-80%” of their treatments. Patient reported on 4/09/24, he/she arrived at the clinic and waited for 30-35 minutes after their scheduled start time. Patient was told by facility staff that they were waiting for other staff to arrive to perform opening water room procedures. Patient reported he/she had to leave the clinic without receiving treatment as Patient had to go to work. 5. The review of the facility’s treatment schedule for 4/09/24 evidenced Patient #17 was scheduled to begin treatment at 5:35 AM. Patient’s medical record indicated he/she missed their treatment on 4/09/24. AA 1 documented Patient’s reason for missed treatment was “Patient Refused to Attend Treatment.” The record evidenced at Patient’s next scheduled treatment on 4/11/24, his/her pre-treatment weight was 76.9 kg, which was 2.1 kg above Patient’s EDW of 76.9 kg. During an interview with Patient #17 on 6/04/24 beginning at 7:17 AM, Patient could not recall what occurred on 4/09/24 and the reason for his/her missed treatment. 6. The review of the facility’s treatment schedule for 4/09/24 evidenced Patient #18 was scheduled to begin treatment at 4:45 AM. Patient’s medical record indicated he/she missed their dialysis treatment on 4/09/24. AA 1 documented Patient’s reason for missed treatment was a “Facility Issue ... technical issues with computer. [Patient] asked to come back and ... did not return.” The record evidenced at Patient’s next scheduled treatment on 4/11/24, his/her pre-treatment weight was 107.2 kg, which was 4.7 kg above Patient’s EDW of 102.5 kg. During an interview with Patient #18 on 6/04/24 beginning at 7:33 AM, Patient reported on several days, he/she was started on treatment late due to a delay in opening water treatment procedures being performed. Patient reported on 4/09/24, he/she arrived at the clinic and waited for 1 hour, then was told by staff it would be another hour before Patient’s treatment could begin. Patient reported he/she left the facility without receiving treatment. Patient reported facility staff did not offer to re-schedule Patient’s treatment nor did facility staff contact Patient later in the day to inform him/her that the clinic had opened. 7. During an interview with AA 1 on 6/03/24 beginning at 3:50 PM, she reported she was not present at the clinic on 4/09/24 and had called the clinic to ask staff the reason Patients #5, 16, 17, and 18 had not attended treatment. AA 1 reported it was her “mistake” that Patients #5, 16, and 17’s missed treatments were documented as “patient refused” since the clinic opened late this date. AA 1 reported the reason for missed treatment should have been documented as a “facility issue.” 8. The review of the facility’s ICHD treatment schedule and treatment flowsheets of 17 patients who received ICHD on 4/09/24 evidenced the following: a. Patient #15 was scheduled to begin treatment at 5:15 AM. Patient’s treatment began at 7:06 AM, which was 1 hour and 51 minutes late. Patient #15 was the first patient to begin treatment on 4/09/24. Patient was ordered to be on treatment for 3 hours and 30 minutes, however on 4/09/24, Patient was on treatment for 1 hour 52 minutes. Patient’s ordered EDW was 64.5 kg and his/her post-treatment weight was 65.7 kg, which was 1.2 kg above his/her EDW. b. Patient #21 was scheduled to begin treatment at 6:10 AM. Patient’s treatment began at 7:14 AM, which was 1 hour 4 minutes late. Patient was ordered to be on treatment for 3 hours and 30 minutes, however on 4/09/24, Patient was on treatment for 2 hours and 26 minutes. c. Patient #26 was scheduled to begin treatment at 6:30 AM. Patient’s treatment began at 8:55 AM, which was 2 hours and 25 minutes late. Patient was ordered to be on treatment for 4 hours, however on 4/09/24, Patient was on treatment for 3 hours and 5 minutes. d. Patient #22 was scheduled to begin treatment at 9:00 AM. Patient’s treatment began at 9:30 AM, which was 30 minutes late. Patient was ordered to be on treatment for 3 hours and 30 minutes, however on 4/09/24, Patient was on treatment for 3 hours and 3 minutes. e. Patient #27 was scheduled to begin treatment at 12:10 PM. Patient’s treatment began at 12:51 PM, which was 41 minutes late. Patient was ordered to be on treatment for 4 hours 15 minutes, however on 4/09/24, Patient was on treatment for 3 hours and 9 minutes. Patient’s ordered EDW was 144.0 kg and his/her post-treatment weight was 145.9 kg, which was 1.9 kg above his/her EDW. 9. The review of the facility’s ICHD treatment schedule and first patient start time for ICHD treatments from 5/01/24 - 5/30/24 evidenced the following: a. On 5/02/24, Patient #18 was scheduled to begin treatment at 4:45 AM. Patient #18 was the first patient started on treatment at 5:12 AM, which was 27 minutes late. b. On 5/03/24, Patient #28 was scheduled to begin treatment at 4:45 AM. Patient #28 was the first patient started on treatment at 5:07 AM, which was 22 minutes late. c. On 5/04/24, Patient #18 was scheduled to begin treatment at 4:45 AM. Patient #18 was the first patient started on treatment at 5:14 AM, which was 29 minutes late. Patient’s scheduled length of treatment was 3 hours 30 minutes and Patient received treatment for 2 hours 54 minutes. Patient’s post treatment weight was 106.8 kg, which was 1.3 kg above Patient’s EDW of 105.5 kg. Patient’s post-treatment sitting blood pressure was 156/86 and standing blood pressure was 178/90. d. On 5/07/24, Patient #18 was scheduled to begin treatment at 4:45 AM. Patient #18 was the first patient started on treatment at 5:08 AM, which was 23 minutes late. e. On 5/17/24, Patient #28 was scheduled to begin treatment at 4:45 AM. Patient #28 was the first patient started on treatment at 5:20 AM, which was 35 minutes late. Patient’s scheduled length of treatment was 3 hours 45 minutes and Patient received treatment for 3 hours 12 minutes. f. On 5/21/24, Patient #18 was scheduled to begin treatment at 4:45 AM. Patient was the first patient started on treatment at 5:06 AM, which was 21 minutes late. g. On 5/30/24, Patient #18 was scheduled to begin treatment at 4:45 AM. Patient was the first patient started on treatment at 5:51 AM, which was 1 hour 6 minutes late. Patient’s scheduled length of treatment was 3 hours 30 minutes and Patient received treatment for 2 hours 36 minutes. During an interview with Administrator on 6/03/24 beginning at 11:45 AM, she reported treatments began late on 5/02/24 and 5/04/24 due to staff call-offs and on 5/30/24 the opening RN “took longer than expected.” The facility had no record of a reason patients were started late on treatment on 5/03/24, 5/07/24, 5/17/24, and 5/21/24. Administrator reported the late starts were likely to float staff not being familiar with the facility and patients. When queried what interventions the facility had enacted to ensure treatments began timely, Administrator reported she was still new to the role and the facility was still working on this issue. 10. During an interview with Medical Director on 5/30/24 beginning at 12:56 PM, he reported the facility had several dates where the ICHD clinic opened late due to staff arriving late. Medical Director reported he was not aware of patients receiving treatment late within the previous 10-15 days.”

“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: 47022 Based on record review and interview, the dialysis facility failed to ensure the Registered Nurse (RN) assessment was completed within 1 hour of the patient hemodialysis start time and was repeated at the end of treatment if the patient exhibited symptoms of fluid overload in 5 of 7 clinical records reviewed (Patient #2, 3, 4, 7, 8), failed to address post-treatment orthostatic hypotension in 1 of 1 clinical record reviewed with a documented orthostatic hypotension post treatment (Patient #3), and failed to ensure medications were administered as ordered to treat low blood pressure in 1 of 7 clinical records reviewed (Patient #4). Findings include: 1. A review of facility policy dated 11/06/2023, titled, “Nursing Supervision and Delegation,” indicated the RN tasks would include assessment of each patient within 1 hour of treatment initiation. 2. A review of facility policy dated 2/07/2022, titled, “Guidelines for Recognizing and Treating Orthostatic Hypotension,” indicated orthostatic hypotension was a drop in blood pressure from sitting to standing that was equal to or greater than 20 systolic (pressure on arteries when heart beats). The policy indicated the staff would recognize, report and treat orthostatic hypotension that occurred after hemodialysis treatment, document interventions provided, and follow up or review of resolution of signs and symptoms. 3. A review of Patient #2’s clinical record included a treatment flowsheet dated 5/20/2024 which indicated the hemodialysis for Patient #2 was started at 10:06 AM and the RN assessment was completed at 1:38 PM. The documentation failed to evidence why the RN assessment was not completed within 1 hour of the hemodialysis start time as per the policy. The treatment sheet dated 05/28/2024 indicated Patient’s hemodialysis started at 1:22 PM and the RN assessment was completed at 3:30 PM. The documentation failed to evidence why the RN assessment was not completed within 1 hour of the hemodialysis start time as per the policy. 4. A review of Patient #3’s clinical record included a treatment flowsheet dated 5/18/2024 which indicated the hemodialysis for Patient #3 was started at 10:39 AM. The RN assessment was completed at 12:31 PM. The documentation failed to evidence why the RN assessment was not completed within 1 hour of the hemodialysis start time as per the policy. The treatment flow sheet dated 5/28/2024 indicated the hemodialysis was started at 10:49 AM and the RN assessment was completed at 12:24 PM. The documentation failed to evidence why the RN assessment was not completed within 1 hour of the hemodialysis start time as per the policy. The treatment sheet dated 05/25/2024 indicated the patient’s post dialysis blood pressure sitting was 153/105 and blood pressure standing was 132/65 with a 21 systolic blood pressure drop. The documentation failed to evidence the 21-point systolic blood pressure drop was reported to the RN or reevaluated prior to the patient’s discharge from the facility. 5. A review of Patient #7’s clinical reocrd included a treatment flowsheet dated 5/17/2024 which indicated the hemodialysis for Patient #7 was started at 10:40 AM. The RN assessment was completed at 12:30 PM. The documentation failed to evidence why the RN assessment was not completed within 1 hour of the hemodialysis start time as per the policy. 6. A review of Patient #8’s clinical record included a treatment flowsheet dated 5/17/2024 which indicated the hemodialysis for Patient #8 was started at 9:48 AM. The RN assessment was completed at 12:32 PM. The documentation failed to evidence why the RN assessment was not completed within 1 hour of the hemodialysis start time as per the policy. 7. During an interview with RN 1 on 6/05/2024 beginning at 1:45 PM, she indicated the RN assessment should be completed on the dialysis patient within 1 hour of the start of the hemodialysis treatment. RN 1 indicated she would expect the PCT to notify the nurse if there was greater than a 30-point drop in the patient’s blood pressure in order for the nurse to evaluate and provide intervention if required. 42617 8. A review of Patient #4’s clinical record indicated Patient’s Estimated Dry Weight (a physician-ordered weight the patient would be at without any extra fluid, which he/she was to within 1 kilogram (kg) by the end of dialysis treatment) was 100.0 kg. The record included an order to administer Midodrine (a medication used to treat hypotension (low blood pressure)) during dialysis treatment as needed for “hypotension”. Patient’s treatment flowsheets between 4/05/24 - 5/29/24 evidenced the following: a. On 4/05/24, Patient’s pre-treatment weight was 110.9 kg. During the pre-treatment nursing assessment, Registered Nurse (RN) 5 documented Patient reported shortness of breath. Patient’s post-treatment weight was 107.5kg, which was 7.5 kg above Patient’s EDW. RN 5 failed to document she re-assessed Patient for shortness of breath and/or other symptoms of hypervolemia (fluid overload), including abnormal lung sounds, swelling of the extremities, etc. On 4/07/24, Patient’s pre-treatment weight was 112.3 kg. During the pre-treatment nursing assessment, RN 6 documented Patient reported shortness of breath and had swelling to the ankles and legs. Patient’s post-treatment weight was 107.3 kg, which was 7.3 kg above Patient’s EDW. On 4/10/24, Patient’s pre-treatment weight was 115.9 kg. During the pre-treatment nursing assessment, RN 6 documented Patient had swelling to the ankles and legs. Patient’s post-treatment weight was 110.5 kg, which was 10.5 kg above Patient’s EDW. Patient was marked as “absent” from his/her dialysis treatment on 4/12/24. On 4/15/24, RN 7 documented Patient had been hospitalized between 4/10/24 - 4/12/24. The record failed to evidence a reason for hospitalization. During an interview with Patient #4 on 5/30/24 beginning at 9:42 AM, Patient reported he/she had to be hospitalized multiple times due to fluid overload and Patient’s weight being significantly above his/her EDW. During an interview with Administrator and Alternate Administrator on 5/29/24 beginning at 4:50 PM, the administrative staff reported RN 5 and RN 6 were float nurses employed by the facility’s corporate float pool and were not currently assigned to work at the facility. b. On 05/20/24, Patient’s pre-treatment weight was 107.5 kg and blood pressure was 110/71. Patient’s treatment started at 4:54 AM. At 7:02 AM, Patient’s blood pressure was 102/57 and at 7:32 AM, Patient’s blood pressure was 91/61. Patient Care Technician (PCT) 3 documented she notified RN 1 of the drop in blood pressure and Patient’s fluid removal goal was decreased. Patient’s blood pressure at 7:42 AM was 91/46. At 8:03 AM, PCT 3 documented Patient’s blood pressure was 96/60 and Patient requested to terminate his/her treatment 40 minutes early. At 8:16 AM, RN 1 documented Patient had requested to terminate his/her treatment early due to their low blood pressure. Patient’s post-treatment weight was 104.3 kg, which was 4.3 kg above Patient’s EDW. The record failed to evidence Midodrine had been administered to treat Patient’s low blood pressure. c. On 5/22/24, Patient’s pre-treatment weight was 105.8 kg and blood pressure was 127/64. At 4:45 AM, RN 1 documented Patient refused a fluid removal goal greater than 4 kilograms due to Patient’s history of low blood pressure occurring with high fluid removal. Patient’s treatment was started at 4:52 AM. At 6:02 AM Patient’s blood pressure was 104/46, at 6:33 AM Patient’s blood pressure was 92/37, at 6:44 AM Patient’s blood pressure was 97/53, and at 7:00 AM Patient’s blood pressure was 95/52. The patient’s fluid removal remained on during this time. At 7:31 AM, Patient’s blood pressure was 96/53 and RN 1 documented Patient’s fluid removal was turned off due to his/her low blood pressure. Patient reported feeling dizzy and RN 1 administered a fluid bolus. Patient’s fluid removal remained off until 8:19 AM when Patient’s blood pressure was 103/55. Patient’s post-treatment weight was 103.9 kg, which was 3.9 kg above Patient’s EDW. During an interview with RN 1 on 6/03/24 beginning at 4:35 PM, the nurse reported she was unaware Patient had orders to administer Midodrine for low blood pressure. RN 1 was unsure if the facility had a supply of Midodrine available to administer to patients.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 47022 Based on observation, record review and interview, the dialysis facility failed to ensure the prescribed blood flow rate (BFR), dialysate flow rate (DFR) and treatment time were provided to the hemodialysis patient as ordered in 6 of 7 clinical records reviewed (Patients #1, 2, 3, 4, 7, 8). Findings include: 1. A review of facility policy dated 11/06/2023, titled, “Nursing Supervision and Delegation,” indicated the Registered Nurse (RN) should review the patient record to ensure the correct dialysate prescription was delivered. 2. A clinical record review for Patient #1 included a review of the dialysis treatment sheets from 05/15/2024 - 05/27/2024 and evidenced the following: a. The treatment sheet dated 05/15/2024 indicated the DFR was prescribed at 800 milliliters/min (ml/min). The DFR was 500 ml/min from treatment start at 11:28 AM - 12:33 PM. The record failed to evidence documentation of why Patient #1 did not receive the prescribed dialysate flow rate. b. The treatment sheet dated 05/17/2024 indicated the DFR was prescribed at 800 ml/min. The hemodialysis DFR was 500 ml/min from treatment start at 11:41 AM - 3:00 PM (end of treatment). The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. c. The treatment sheet dated 05/20/2024 indicated the DFR was prescribed at 800 ml/min. The hemodialysis started at 11:23 AM, at 12:32 PM the DFR was documented at 500 ml/min until 3:17 PM (end of treatment). The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. d. The treatment sheet dated 05/22/2024 indicated the DFR was prescribed at 800 ml/min. The hemodialysis started at 11:23 AM, at 1:34 PM the DFR was documented at 500 ml/min until 3:21 PM (end of treatment). The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. 3. A clinical record review for Patient #2 included a review of the dialysis treatment sheets from 05/15/2024-05/28/2024 and evidenced the following: a. The treatment sheet dated 05/15/2024 indicated the prescribed treatment hours should be 3 hours and 30 minutes. The treatment sheet indicated the hemodialysis started at 10:14 AM and ended at 1:05 PM, and failed to evidence documentation of why the patient did not receive the 3 hours and 30 minute treatment. b. The treatment sheet dated 05/17/2024 indicated the DFR was prescribed at 800 ml/min. The hemodialysis started at 9:42 AM and the DFR was at 500 ml/min until end of treatment at 1:21 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. c. The treatment sheet dated 05/22/2024 indicated the BFR was prescribed at 400. The hemodialysis started at 10:09 AM with a BFR of 300, beginning at 11:11 AM the BFR was 350, the BFR was at 250 at 1:08 PM and treatment ended at 1:13 PM. The review failed to evidence documentation of why the patient did not receive the prescribed blood flow rate. d. The treatment sheet dated 05/28/2024 indicated the BFR was prescribed at 400. The hemodialysis started at 1:22 PM at BFR 300 and continued at BFR 350 at 2:01 PM until the end of treatment at 4:45 PM. The review failed to evidence documentation of why the patient did not receive the prescribed blood flow rate. 4. A clinical record review for Patient #3 included a review of the hemodialysis treatment sheets from 05/18/2024 - 05/28/2024 and evidenced the following: a. The treatment sheet dated 05/18/2024 indicated the DFR was prescribed at 600 ml/min. The hemodialysis started at 10:39 AM at DFR 500 ml/min and continued at 500 ml/min DFR until the end of treatment at 12:10 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. b. The treatment sheet dated 05/21/2024 indicated the BFR was prescribed at 350 and the DFR was prescribed at 600 ml/min. The hemodialysis started at 10:54 AM at DFR 500 ml/min and continued at 500 ml/min until the end of treatment at 12:24 PM. At 11:04 AM the BFR was at 450 ml/min and continued at BFR at 450 ml/min until the end of treatment at 12:24 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysis flow rate or the blood flow rate. c. The treatment sheet dated 05/28/2024 indicated the DFR was prescribed at 600 ml/min. The hemodialysis was started at 10:49 AM with a DFR at 500 ml/min until 12:33 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. 5. A clinical record review for Patient #7 included a review of the hemodialysis treatment sheets from 05/15/2024 - 05/27/2024 and evidenced the following: a. The treatment sheet dated 05/13/2024 indicated the BFR was prescribed at 300. The hemodialysis started at 11:35 AM and the BFR from 12:01 PM-2:05 PM (end of treatment) was 250. The review failed to evidence documentation of why the patient did not receive the prescribed blood flow rate. b. The treatment sheet dated 05/17/2024 indicated the DFR was prescribed at 600 ml/min. The hemodialysis was started at 10:40 AM with a DFR at 500 ml/min until end of treatment at 2:06 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. c. The treatment sheet dated 05/24/2024 indicated the DFR was prescribed at 600 ml/min. The hemodialysis started at 10:33 AM with a DFR at 500 ml/min until end of treatment at 2:06 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. d. The treatment sheet dated 05/27/2024 indicated the DFR was prescribed at 600 ml/min. The hemodialysis was started at 10:46 AM with a DFR at 500 ml/min until the end of treatment at 2:25 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. During an in-center hemodialysis observation on 06/05/2024 beginning at 1:45 PM, while Patient received dialysis, RN 1 verified Patient’s dialysis settings. The review of the prescription indicated the DFR was prescribed at 600 ml/min. The observation evidenced the patient was receiving DFR at 800 ml/min. RN 1 indicated the patient was not receiving the correct DFR prescription. 6. A clinical record review for Patient #8 included a review of the hemodialysis treatment sheets from 05/15/2024 - 05/27/2024 and evidenced the following: a. The treatment sheet dated 05/20/2024 indicated the DFR was prescribed at 500 ml/min. The hemodialysis started at 9:55 AM and at 11:00 AM the DFR was at 800 ml/min until end of treatment at 1:33 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. b. The treatment sheet dated 05/22/2024 indicated the BFR was prescribed at 350. The hemodialysis started at 9:24 AM and at 12:01 PM the BFR was at 300 until the end of treatment at 1:01 PM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. 7. During an interview on 06/05/2024, beginning at 1:45 PM, PCT 2 indicated the DFR and BFR should be set as prescribed and if there were an adjustment made, it would be after the RN discussed with the physician, and documentation would be included on the treatment sheet. 42617 8.A clinical record review for Patient #4 included a review of the hemodialysis treatment sheets from 05/15/2024 - 05/29/2024 and evidenced the following: a. The treatment sheet dated 05/15/2024 indicated the DFR was prescribed at 800 ml/min. Patient’s DFR remained at 300 ml/min for the length of treatment. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. b. The treatment sheet dated 5/24/24 indicatd the DFR was prescribed at 800 ml/min. The hemodialysis started at 5:04 AM and at 7:31 AM Patient’s DFR was at 500 until the end of treatment at 8:30 AM. The review failed to evidence documentation of why the patient did not receive the prescribed dialysate flow rate. c. The treatment sheet dated 5/27/24 indicated the DFR was prescribed at 800 ml/min. for the last 59 minutes of the treatment. The flowsheet failed to evidence a reason staff did not adhere to the ordered DFR. During an interview with PCT 1 on 5/30/24 at 2:10 PM, she reported the DFR was set according to the patient’s dialysis prescription. After reviewing the treatment flowsheet from 5/15/24, PCT 1 stated she must have forgotten to increase Patient’s DFR to the ordered 800 ml/min after initiating treatment. After reviewing the treatment flowsheet for 5/24/24, PCT 1 reported she had noticed the dialysis machines would occasionally change the DFR to 500 ml/min despite being set for a different amount.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to administer medications for the treatment of anemia (a condition where the number of red blood cells is decreased) according to the patient’s plan of care for 1 of 2 records reviewed for anemia management (Patient #6). Findings include: The review of Patient #6’s clinical record included a current plan of care, dated 1/26/24, which indicated Patient’s anemia goal was for a hemoglobin (blood test which measures the level of the hemoglobin protein on red blood cells, which can indicate anemia) level between “10-11 g/dL [grams per deciliter].” Interventions for this goal included administering an Erythropoiesis-stimulating agent (ESA, a medication used to stimulate red blood cell production, such as Mircera) according to the facility’s dosing algorithm. The record included an “Anemia Algorithm Dose Change Assessment,” documented on 4/18/24 by Corporate Registered Nurse (RN) 4. The assessment indicated Patient’s Mircera dose was changed from 50 micrograms (mcg) every 2 weeks to 75 micrograms every 4 weeks. Mircera was last documented as administered on 3/23/24. The record failed to evidence a reason the previous dose of Mircera, which was to be given every 2 weeks, had not been administered. Patient hemoglobin lab results between 3/12/24 - 5/21/24 evidenced the following testing dates and hemoglobin results: a. 3/12/24 - 9.3 g/dL b. 3/28/24 - 10.2 g/dL c. 4/16/24 - 10.7 g/dL d. 5/09/24 - 9.0 g/dL e. 5/21/24 - 6.6 g/dL Patient’s treatment flowsheets between 5/16/24 - 5/28/24 evidenced the following: a. On 5/16/24, Patient’s date of last Mircera administration was 3/23/24. b. On 5/21/24, Mircera 75 mcg was administered by RN 3. This was the first documented dose of Mircera administered since 3/23/24. The record failed to evidence a reason the Mircera had not been administered between 3/23/24 - 5/21/24. During an interview with RN 1 on 6/05/24 beginning at 4:03 PM, the nurse confirmed Patient did not receive a dose of Mircera between 3/23/24 - 5/21/24 and there was no documented reason for the missing dose(s). RN 1 reported Mircera doses were scheduled for either a Friday or Saturday treatment, and Patient frequently missed dialysis treatments on these days. RN 1 reported Patient received a blood transfusion after the Hemoglobin result of 6.6 g/dL on 5/21/24, and Patient’s last Hemoglobin on 6/04/24 was 8.2 g/dL.”

“POC-TRANSPLANT STATUS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(ii) When the patient is a transplant referral candidate, the interdisciplinary team must develop plans for pursuing transplantation. The patient’s plan of care must include documentation of the- (A) Plan for transplantation, if the patient accepts the transplantation referral; (B) Patient’s decision, if the patient is a transplantation referral candidate but declines the transplantation referral; or (C) Reason(s) for the patient’s nonreferral as a transplantation candidate as documented in accordance with §494.80(a)(10). This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to develop and implement plans for pursing kidney transplantation for 1 of 7 active records reviewed (Patient #4). Findings include: 1. A review of Patient #4’s clinical record included a current plan of care, dated 12/15/23, which indicated Patient’s goals included “place Patient on transplant list as indicated ....” MSW 1 documented Patient had a repeat referral sent to Entity B, a kidney transplant center. The record included a “Transplant Assessment,” dated 3/11/24 and completed by MSW 1, which indicated Patient was interested in kidney transplantation but was not on the transplant list. The social worker documented “[Patient] wants to try again for transplant as [he/she] feels [his/her] health issues are better.” The assessment indicated a referral was submitted to Entity B but failed to evidence the date of submission. The review of Patient’s physician rounding notes for the previous 3 months included a physician rounding note dated 3/08/24 and documented by Other Physician 1. She documented Patient had been “turned down” by Entities B and C, a transplant center, and wanted a referral Entity D. During an interview with Patient #4 on 5/30/24 beginning at 9:42 AM, he/she reported they had recently requested Medical Social Worker (MSW) 1 submit a referral to Entity D, a transplant center, for kidney transplant workup. Patient stated he/she had not received any further information from MSW 1 nor other facility staff regarding the request, so he/she called the entity directly in attempts to schedule a consultation for kidney transplant. During an interview with MSW 1 on 5/31/24 beginning at 3:15 PM, the social worker reported she reviewed transplantation status for all patients on admission, quarterly, and as needed. Patient had been denied for transplantation workup by Entities B and C. Patient was still interested in transplant, so the social worker had sent a second referral for transplant to Entity B on 3/30/24. On 4/09/24, MSW 1 received email notification from Entity B stating that the transplant center was declining to evaluate Patient for transplantation. MSW 1 reported she was not aware Patient wanted a referral to Entity D and she was unaware if anyone from the facility had submitted a referral to this transplant center.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 42617 Based on record review and interview, the dialysis facility failed to take actions which resulted in performance improvement specific to late total chlorine testing of the in-center hemodialysis (ICHD) product water, which had the potential to affect 61 active ICHD patients. Findings include: 1. A review of facility policy #1457 titled “Carbon Filtration Monitoring of Central Water Systems ...,” dated 9/05/23, indicated the facility’s product water would be tested for total chlorine (TCL) levels “prior to the initiation of the first patient treatment of the day and at a minimum of every four hours ....” 2. A review of the facility Quality Assessment and Performance Improvement (QAPI) meeting minutes between December 2023 - May 2024 evidenced the following: a. During the QAPI meeting held 12/14/23 to review November 2023 quality indicators, the committee noted 2 TCL tests were performed late and 1 TCL test was performed prior to the product water running for 20 minutes. b. During the QAPI meeting held 1/26/24 to review December 2023 quality indicators, the committee noted 2 TCL tests were performed late. c. During the QAPI meeting held 2/23/24 to review January 2024 quality indicators, the committee noted 3 TCL tests were performed late. The minutes indicated the committee discussed “starting action plan for TCL checks” and the biomed technicians had “worked with staff when educating” on the facility’s new water treatment system. A review of a facility document titled “Action Plan,” dated 2/23/24, indicated the QAPI committee had noted “multiple” TCL tests had been performed late in January 2024. The committee identified “root causes” as the “clinic opened late several times and TCL ... testing was not performed on time due to staffing issues.” The facility’s goal was 100% of TCL tests were documented on time. If staff did not document the test on time, the log was to indicate the reason for the late documentation. The action plan’s goal was for 100% compliance to be achieved by the April 2024 meeting. Actions planned to achieve this goal included education to be provided to facility staff during a meeting on 2/29/24. Alternate Administrator was to review the TCL testing logs “weekly” and Biomed Technician 1 was to review the logs “as usual.” d. During the QAPI meeting held 3/15/24 to review February 2024 quality indicators, the committee noted 4 TCL tests were performed late. The minutes failed to evidence the QAPI committee discussed the status of its action plan for TCL testing. e. During the QAPI meeting held 4/19/24 to review March 2024 quality indicators, the committee noted 3 TCL tests were performed late. The minutes failed to evidence the QAPI committee discussed the status of its action plan for TCL testing. f. During the QAPI meeting held 5/17/24 to review April 2024 quality indicators, the committee noted 4 TCL tests were performed late. The minutes failed to evidence the QAPI committee discussed the status of its action plan for TCL testing. 3. A review of the facility’s ICHD total chlorine testing logs for 5/01/24 - 5/29/24 evidenced the following: a. On 5/03/24, one TCL test was logged at 7:40 PM. The log failed to evidence previous testing had been performed that day. A review of the first patient treatment initiated on 5/03/24 indicated Patient #28 was the first patient treatment initiated at 5:07 AM. b. On 5/06/24, the first TCL test was logged at 8:05 AM. The log failed to evidence a TCL test was performed prior to patient treatment beginning. A review of the first patient treatment time initiated on 5/06/23 indicated Patient #4 was the first patient treatment initiated at 4:59 AM. c. On 5/07/24, the first TCL test was logged at 7:42 AM. A review of treatment records for 5/07/24 indicated Patient #18 was the first patient treatment initiated at 5:08 AM. d. On 5/10/24, a TCL test was logged at 11:52 AM. The next test was not logged as completed until 4:23 PM, which was 4 hours and 31 minutes in between tests. e. On 5/13/24, the first TCL test was logged at 8:13 AM by Registered Nurse (RN) 2 and Patient Care Technician (PCT) 6. The log included a note which stated the first test “was not late,” however the log indicated this was the first TCL test documented for 5/13/24. A review of treatment records for 5/13/24 indicated Patient #29 was the first patient treatment initiated at 4:52 AM. The next TCL test was logged at 12:12 PM. f. On 5/14/24, the first TCL test was logged at 8:02 AM by RN 2 and PCT 6. The log included a note which indicated “first [test was performed] in AM prior to first patient,” however the log failed to evidence a TCL test documented prior to 8:02 AM. A review of treatment records for 5/14/24 indicated Patient #18 was the first patient treatment initiated at 4:58 AM. The next TCL test was logged at 12:16 PM. g. On 5/15/24, the first TCL test was logged at 8:26 AM. A review of treatment records indicated Patient #29 was the first patient treatment initiated at 4:45 AM. h. On 5/21/24, a TCL test was logged at 9:40 AM by RN 3 and PCT 7. The log included a note which indicated the test was entered late “due to internet outage.” The log indicated the next TCL test was not documented until 2:00 PM, which was 4 hours 20 minutes after the previous documented test. i. On 5/23/24, a TCL test was logged at 8:00 AM. A review of treatment records indicated Patient #18 was the first patient treatment initiated at 4:44 AM. TCL testing was then performed at 11:53 AM and 4:00 PM, a difference of 4 hours and 7 minutes. j. On 5/25/25, a TCL test was logged at 7:24 AM. A review of treatment records indicated Patient #18 was the first patient treatment initiated at 4:40 AM. 4. During an interview with Biomed Technician 1 on 5/29/24 beginning at 4:39 PM, he reported the facility’s product water should be tested to ensure total chlorine levels were below actionable levels prior to the initiation of the first ICHD patient treatment and every 4 hours subsequently. Biomed Technician 1 reported he reviewed the TCL logs monthly for compliance with this requirement and would present the results during monthly QAPI meetings. The employee stated the QAPI committee had developed an action plan to address the missed or late treatment, however the employee was unsure of what interventions had been planned and/or initiated. 5. During an interview with Administrator and Alternate Administrator on 5/29/24 beginning at 4:50 PM, Alternate Administrator reported the facility had been staffed by a rotation of travel nurses and technicians which resulted in difficulty ensuring the TCL testing was being performed according to facility policy. When queried if the QAPI committee had enacted an action plan related to this issue, the administrative staff reported they were not aware of any current or previous action plans to address the missed and late TCL testing.”

“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, and interview, the Medical Director failed to ensure all policies and procedures were followed by staff for 2 of 2 observations of staff performing cannulation of an arteriovenous (AV) fistula (PCT 2, 3) and 1 of 2 observations of staff terminating dialysis for a patient with an AV fistula (PCT 3). Findings include: 1. A review of facility policy #45178 titled “Access Assessment and Cannulation,” dated 5/06/24, indicated when disinfecting the fistula cannulation site with a 70% alcohol pad, staff should disinfect the site for 30 seconds prior to cannulation. 2. A review of facility policy titled “Post Treatment Fistula Needle Removal,” dated 7/06/21, indicated after the cannulation needle was removed, gauze should be immediately applied, and pressure held to the site for 5-10 minutes. Once hemostasis (bleeding stopped) was achieved, staff were to remove the bloodied gauze and place a “Band-Aid, adhesive dressing, or gauze dressing secured with clean tape” to the area. 3. During an observation on 6/04/24 beginning at 4:47 AM, PCT 2 was observed at Station 3 cannulating Patient #16’s AV fistula. The technician disinfected the first cannulation site for 5 seconds with an alcohol wipe and the second cannulation site for 6 seconds. During an interview with PCT 2 on 6/04/24 at 6:26 AM, PCT 2 reported each cannulation site should be disinfected for 15 seconds with an alcohol pad. 4. During an observation on 6/04/24 beginning at 4:58 AM, PCT 3 was observed at Station 7 cannulating Patient #14’s AV fistula. The technician disinfected the first cannulation site for 11 seconds. During an interview with PCT 3 on 6/04/24 at 6:16 AM, PCT 3 reported each cannulation site should be disinfected for 30 seconds with an alcohol pad. 5. During an observation on 6/04/24 beginning at 10:14 AM, PCT 3 was observed at Station 5 terminating Patient #21’s dialysis. After the cannulation needles were removed and hemostasis was achieved, PCT 3 kept the bloodied gauze over the cannulation sites and applied additional tape. The technician failed to change out the bloodied gauze after hemostasis was achieved. During an interview with PCT 3 on 6/04/24 beginning at 3:40 PM, the technician reported she did not change bloodied gauze at an AV fistula cannulation site after hemostasis was achieved.”

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 47022 Based on observation, record review, and interview, the dialysis facility failed to ensure employees had completed an orientation to the facility and their work responsibilities in 1 of 2 Float Patient Care Technician (PCT) Personnel Records Reviewed (Float PCT 1). Findings include: A treatment sheet review for Patient #1 indicated PCT 1 completed care on the patient on 05/15/2024. A treatment sheet review for Patient #2 indicated PCT 1 completed care on the patient on 05/25/2024. A treatment sheet review for Patient #7 indicated PCT 1 completed care on the patient on 05/15/2024. A treatment sheet review for Patient #8 indicated PCT 1 completed care on the patient on 05/15/2024. A personnel record review for PCT #1 failed to evidence orientation was completed. During an interview on 06/06/2024 at 2:46 PM, Alternate Administrator indicated there was not an orientation completed for PCT #1. 42617 During a flash tour observation of the in-center hemodialysis (ICHD) treatment floor on 5/29/24 beginning at 9:01 AM, PCT 1 was observed providing direct patent care to Patient #9.”