Fmc - Mt. Sterling

“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: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure that staff performed hand hygiene per the facility policy’s for 2 of 5 staff observed performing patient care activities, Registered Nurse (RN) 8 and Patient Care Technician (PCT) 5. The findings include: Review of the facility’s policy titled, “Hand Hygiene,” published 11/06/2023, revealed, “The table below identifies when hands shall be washed specifically with soap and water or when alcohol-based hand rubs can be used.” The table included “- Before and after direct contact with patients - Entering and leaving the treatment area - Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications - Immediately after removing gloves - After contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled - After contact with inanimate objects near the patient - When moving from a contaminated body site to a clean body site of the same patient - After contact with the dialysis wall box, concentrate, drain, or water lines, - After contact with other objects within the patient station or treatment space.” Observation on 04/23/2025 at 9:50 AM, revealed RN8 was at Patient Treatment Station 17 discontinuing dialysis treatment for a patient with an arteriovenous fistula (AVF). After reinfusing the patient’s blood, RN8 removed the patient’s bloodlines and then removed the first cannulation needle. RN8 failed to perform hand hygiene or change gloves prior to removing the cannulation needles. Observation on 04/23/2025 at 9:59 AM, revealed PCT5 was at Patient Treatment Station 3 discontinuing dialysis treatment for a patient with an AVF. PCT5 assisted the patient to move their personal items. PCT5 then removed the patient’s bloodlines and removed the first cannulation needle. PCT5 failed to perform hand hygiene or change gloves prior to removing the cannulation needles. Observation on 04/23/2025 at 10:02 AM, revealed RN8 was at Patient Treatment Station 15 discontinuing dialysis treatment for a patient with an AVF. RN8 clamped the patient’s bloodlines, assisted the patient to put on a glove, removed the patient’s bloodlines, then removed the first cannulation needle. RN8 failed to perform hand hygiene or change their gloves prior to removing the cannulation needles. Observation on 04/23/2025 at 10:15 AM, revealed PCT5 was at Patient Treatment Station 1 initiating dialysis treatment for a patient with an AVF. PCT5 performed hand hygiene, put on gloves, cleaned the access with soap and water, performed hand hygiene, changed gloves, applied a tourniquet, touched the access to show the patient where to apply a numbing spray, and then PCT5 cannulated the site. PCT5 failed to perform hand hygiene before performing vascular access cannulation. During an interview on 04/23/2025 at 12:20 PM, RN8 stated she did not change gloves and perform hand hygiene prior to pulling the cannulation needles. RN8 stated it was her normal process to perform hand hygiene and put on clean gloves, get the patient’s blood pressure and document it, reinfuse the patient’s blood, get a final blood pressure with the patient sitting and standing with the lines connected, if possible, disconnect the blood lines, and then pull the cannulation needles one at a time. RN8 stated she was unsure if that was the way she was trained to discontinue dialysis treatment for a patient with an AVF. During an interview on 04/24/2025 at 12:17 PM, PCT5 stated she was expected to perform hand hygiene prior to insertion of and removal of cannulation needles, and she did not follow the expectation. PCT5 stated the patient in Patient Treatment Station 3 was often grumpy and impatient to leave at the end of treatment. However, she stated she should have performed hand hygiene and changed gloves. During an interview on 04/25/2025 at 3:43 PM, the Medical Director stated it was his expectation for hand hygiene to be performed per the facility’s policy.”

“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: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure all environmental surfaces were disinfected at the end of each dialysis treatment for 2 of 2 observations of post-treatment station disinfection. The findings include: Review of the facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station,” published 09/05/2023, revealed the section titled, “Background,” included, “The Centers for Medicare and Medicaid Services (CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses.” Further review of the policy revealed, “Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments such as IV [intravenous] pole, BP [blood pressure] cuff and hand sanitizer/holder, organizer.” Observation of the hemodialysis treatment area on 04/23/2025 at 10:01 AM, revealed Patient Care Technician (PCT) 5 was disinfecting Patient Treatment Station 3 following a dialysis treatment. PCT5 failed to disinfect the counter behind the treatment chair. Observation of the hemodialysis treatment area on 04/23/2025 at 2:45 PM, revealed PCT2 was disinfecting Patient Treatment Station 3 following a dialysis treatment. PCT2 failed to disinfect the counter behind the treatment chair and the prime waste receptacle. During an interview on 04/23/2025 at 3:14 PM, PCT2 stated she did not disinfect the counter behind the treatment chair and the prime waste receptacle. PCT2 stated she did not clean the counters behind the chairs because they did not utilize those counters. PCT2 stated she forgot to clean the prime waste receptacle due to having multiple patients with treatments back-to-back. During an interview on 04/24/2025 at 12:17 PM, PCT5 stated the counter behind the treatment chair was not disinfected. PCT5 stated she was “hit or miss with it” but generally cleaned the counter at the end of the day. During an interview on 04/25/2025 at 2:43 PM, the Medical Director stated his expectation was that all dialysis treatment stations be cleaned as directed by the facility’s policy after every dialysis treatment.”

“IC-HBV-ISOLATION-STAFFING CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients Staff members caring for HBsAg positive patients should not care for HBV susceptible patients at the same time, including during the period when dialysis is terminated on one patient and initiated on another. This Standard is not met as evidenced by: 50873 Based on interview, record review, and facility document and policy review, the facility failed to ensure staff isolated Hepatitis B positive patients from 2 of 3 susceptible patients sampled, Patients S11 and S12. The findings include: Review of the facility’s policy titled, “Dialyzing Patients with Positive Hepatitis B Antigen (HBsAg+),” published 11/06/2023, revealed, “HBsAg positive: Tested positive for the presence of hepatitis B surface antigen indicating the person is infectious.” Further review revealed, “Staff having any contact with the HBsAg positive patient must at the same time have NO contact with susceptible patients.” Review of the facility’s document “Hepatitis B Summary Report,” created on 04/22/2025, indicated that Patient 7 was “HBsAg: POSITIVE” and that Patient S11 and Patient S12 were susceptible to Hepatitis B. Review of Patient 7’s “Treatment Sheet for Facility,” dated 04/14/2025, revealed Registered Nurse (RN) 9 provided care for Patient 7 from 6:16 AM until 10:35 AM. Review of Patient S11’s “Treatment Sheet for Facility,” dated 04/14/2025, revealed RN9 documented giving Patient S11 a medication at 9:30 AM, which was during the time period when RN 9 was also providing care for Patient 7. Review of Patient S12’s “Treatment Sheet for Facility,” dated 04/14/2025, revealed RN9 documented “Post-dialysis vitals and evaluation” for Patient S12 at 9:11 AM, which was during the time period when RN9 was also providing care for Patient 7. During an interview on 04/23/2025 at 4:15 PM, the Clinic Manager stated the Hepatitis B susceptible patients, Patient S11 and Patient S12, received care from RN9 at the same time RN9 was also providing care for a Hepatitis B positive patient. The Clinic Manager stated that should not have happened. During an interview on 04/23/2025 at 12:20 PM, RN8 stated that Patient Treatment Station 13, 14, 15, and 16 were considered the buffer zone, and those were the stations an RN was assigned to when caring for Hepatitis B positive patients. RN8 stated staff members providing care for Hepatitis B positive patients only provided care for patients in the buffer zone. RN8 stated there was not a designated staff member to cover for the person working in the buffer zone. During an interview on 04/24/2025 at 12:17 PM, Patient Care Technician (PCT) 5 stated staff only provided care for Hepatitis B positive patients and patients who were immune to Hepatitis B in the buffer zone. PCT5 stated that if patient assignments needed to be adjusted, the nurse would have to ensure that any patient moved into the buffer zone would have to be immune to Hepatitis B. During an interview on 04/24/2025 at 1:55 PM, RN9 reviewed the “Treatment Sheet for Facility,” dated 04/14/2025, for Patient 7, Patient S11, and Patient S12. RN9 stated she would often help the other nurse by signing off on items that she saw had been done by the other staff, such as medication that had been administered. RN9 stated she might have made a mistake and forgotten to check a patient’s immune status prior to providing care, and she could not be sure what happened on that day. During an interview on 04/25/2025 at 3:43 PM, the Medical Director stated he expected that care providers did not provide care to patients that were Hepatitis B positive and patients who were susceptible to Hepatitis B at the same time.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure that 1 of 1 water softener brine tanks had salt levels maintained at a minimum of half full, per the facility’s policy. The findings include: Review of the facility’s policy titled, “Water Softener,” published 05/03/2023, indicated, “For all water softeners: At a minimum, facility staff will monitor and document water softener(s) for the following each operational day: - Check brine tank daily to be sure the tank is at least half filled with salt, adding salt pellets if necessary.” Further review revealed, “Salt levels inside brine tanks will be maintained at a minimum of half full.” The policy revealed the section titled, “Maintenance,” included “Brine Tank: Perform the annual PM [preventative maintenance] procedure in the approved electronic documentation system PM procedure.” 1. Observation on 04/22/2025 at 10:36 AM, revealed the water softener brine tank was approximately 25% filled with salt. There was a second brine tank located next to the organic scavenger tank that was observed to be 10% filled with salt. This brine tank had a handwritten note taped to the lid of the tank that read, “Please do not fill up the brine tank completely. This tank does not have a grate on it and will cause the salt to clump up and cause softener issues. Please fill with one bag [of salt] every other day if no salt is in tank.” During a concurrent interview with the observation, Registered Nurse (RN) 6 stated the tanks were not 50% filled with salt, and the tanks should be 50% filled with salt. During an interview on 04/22/2025 at 10:47 AM, the Biomedical Technician (Biomed Tech) stated the sign on the brine tank was due to the brine tank needing to be emptied for cleaning. 2. Observation on 04/24/2025 at 9:37 AM, revealed the water softener brine tank was half full of salt and the organic scavenger brine tank was approximately 1/3 full. During a concurrent interview with the observation, the Biomed Tech stated the water softener brine tank was half full of salt and the organic scavenger brine tank was approximately 1/3 full. The Biomed Tech stated the brine tanks were cleaned on 04/22/2025, and the organic scavenger brine tank went through a backwash cycle the previous night. The Biomed Tech stated he did not realize he was out of salt but would have more by the end of the day. During an interview on 04/24/2025 at 1:45 PM, the Area Technical Manager (ATOM) reviewed the manufacturer’s instructions for use for the water softener and brine tank and stated that it did not include instructions for cleaning the brine tanks. The ATOM stated, depending on the size of the brine tank, the clinic could be out of compliance with the requirement for the tank to be half full for up to a week every year when cleaning was conducted. The ATOM stated cleaning the brine tank was part of the company’s annual maintenance checklist, but there was no written procedure to outline how this was to be done. The ATOM stated the facility’s practice was to wait for the salt levels to deplete prior to cleaning to avoid wasting salt. During an interview on 04/25/2025 at 11:01 AM, the ATOM stated there was no written procedure outlining how to clean the brine tank and no written training instructions or skills check list regarding cleaning the brine tanks. During an interview on 04/25/2025 at 3:43 PM, the Medical Director stated the facility should have procedures in place for all staff tasks, including cleaning the brine tanks. The Medical Director also stated his expectation was for the brine tanks to be filled according to the facility’s policy.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 50873 Based on observation, interview, and facility policy review, the facility failed to ensure that 1 of 14 oxygen tanks was properly stored. The findings include: Review of the facility’s policy titled, “Emergency Administration of Oxygen,” published 11/01/2021, revealed, “Oxygen cylinders must be secured in an area where they will not fall.” Observation on 04/22/2025 at 11:21 AM, revealed one out of 14 tanks, located to the left of the back entrance to the treatment floor, was unsecured. During a concurrent interview with the observation, Registered Nurse (RN) 6 stated the rack on the left was for storing oxygen tanks that were not empty, and the rack on the right was for empty tanks. RN6 stated the tank might have been left unsecured due to the tank not being empty, and the rack on the left being full. During an interview on 04/22/2025 at 6:05 PM, the Clinic Manager stated it was her expectation that oxygen tanks be securely stored. During an interview on 04/25/2025 at 3:43 PM, the Medical Director stated it was his expectation that oxygen tanks be stored securely.”

“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: 50873 Based on interview, record review, and facility policy review, the facility failed to ensure staff monitored the patient’s fluid status according to the facility’s policy for 5 of 7 patients sampled for record review, Patient (P) 1, P2, P3, P4, and P5. The findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, revealed the section titled, “During Treatment,” included, “- Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations.” The policy revealed, “Report to the nurse: - Systolic blood pressures greater than 180 mm/Hg [millimeters of mercury] - Diastolic blood pressure greater than 100 mm/Hg - Blood pressure less than or equal to 100 mm/Hg systolic.” Further review revealed, “Report to the nurse patients whose heart rates have dropped below 60 [beats per minute, bpm], risen above 100 [bpm] or become irregular.” 1. Review of P1’s “Treatment Sheet for Facility,” dated 04/15/2025, revealed the following: - Patient Care Technician (PCT) 2 documented that at 7:32 AM the patient’s heart rate was 57 bpm. - PCT2 documented that at 8:01 AM the patient’s heart rate was 53 bpm. - PCT2 documented that at 8:32 AM the patient’s heart rate was 51 bpm. - PCT5 documented that at 8:46 AM the patient’s heart rate was 50 bpm. Further review revealed there was no evidence that a Registered Nurse (RN) was notified of the out-of-range heart rates. Review of P1’s “Treatment Sheet for Facility,” dated 04/17/2025, revealed no evidence of vital signs being recorded from 8:03 AM until 9:01 AM (58 minutes between checks). 2. Review of P2’s “Treatment Sheet for Facility,” dated 04/08/2025, revealed no evidence of vital signs being recorded from 10:35 AM until 11:32 AM (57 minutes between checks). Review of P2’s “Treatment Sheet for Facility,” dated 04/10/2025, revealed the following: - PCT3 documented that at 10:31 AM the patient’s blood pressure was 200/102 mm/Hg. - PCT2 documented that at 12:01 PM the patient’s blood pressure was 195/99 mm/Hg. - PCT3 documented that at 12:31 PM the patient’s blood pressure was 204/101 mm/Hg. Further review revealed there was no evidence that an RN was notified of the out-of-range blood pressures. During an interview on 04/25/2025 at 1:25 PM, the Clinic Manager stated there was no evidence of RN notification of P2’s out-of-range vital signs on 04/10/2025. Review of P2’s “Treatment Sheet for Facility,” dated 04/12/2025, revealed PCT3 documented the following: - At 10:31 AM the patient’s blood pressure was 184/107 mm/Hg. - At 11:31 AM the patient’s blood pressure was 186/87 mm/Hg. - At 12:01 PM the patient’s blood pressure was 185/85 mm/Hg. Further review revealed there was no evidence that an RN was notified of the out-of-range blood pressures. Review P2’s “Treatment Sheet for Facility,” dated 04/15/2025, revealed PCT4 documented that at 10:10 AM the patient’s blood pressure was 192/96 mm/Hg, and at 10:16 AM it was 186/100 mm/Hg. Further review revealed there was no evidence that an RN was notified of the out-of-range blood pressures. Review of P2’s “Treatment Sheet for Facility,” dated 04/15/2025, revealed the following: - RN8 documented that at 10:32 AM the patient’s blood pressure was 192/99 mm/Hg. - RN8 documented that at 11:01 AM the patient’s blood pressure was 185/99 mm/Hg. - RN8 documented that at 11:32 AM the patient’s blood pressure was 185/98 mm/Hg. - RN6 documented that at 12:02 PM the patient’s blood pressure was 189/105 mm/Hg. - RN7 documented that at 12:33 PM the patient’s blood pressure was 185/101 mm/Hg. - RN7 documented that at 1:01 PM the patient’s blood pressure was 197/103 mm/Hg. - RN8 documented that at 1:17 PM the patient’s blood pressure was 200/93 mm/Hg. - RN8 documented that at 1:19 PM the patient’s blood pressure was 184/101 mm/Hg. Further review revealed there was no evidence RN6, RN7, or RN8 notified the provider of the out-of-range blood pressures for the duration of the dialysis treatment. Review of P2’s “Treatment Sheet for Facility,” dated 04/17/2025, revealed the following: - PCT3 documented that at 10:31 AM the patient’s heart rate was 57 bpm. - PCT3 documented that at 11:01 AM the patient’s heart rate was 56 bpm. - PCT3 documented that at 12:01 PM P2’s heart rate was 55 bpm, and the patient’s blood pressure was 93/53. - PCT5 documented that at 12:34 PM the patient’s heart rate was 57 bpm. - PCT3 documented that at 1:02 PM the patient’s heart rate was 55 bpm. - PCT3 documented that at 1:13 PM the patient’s heart rate was 57 bpm. Further review revealed there was no evidence the RN was notified of the out-of-range vital signs. Review of P2’s “Treatment Sheet for Facility,” dated 04/19/2025, revealed RN9 documented that at 10:10 AM the patient’s blood pressure was 190/92 mm/Hg, and at 10:18 AM it was 200/92 mm/Hg. Further review revealed there was no evidence the provider was notified of the out-of-range blood pressures. 3. Review of P3’s “Treatment Sheet for Facility,” dated 04/14/2025, revealed the section titled “Special Attentions” included an order for “per [providers name] may start patient with a blood pressure less than equal to 200 systolic and 100 diastolic.” The treatment sheet revealed the following: - RN9 documented that at 5:59 AM the patient’s blood pressure was 181/106 mm/Hg. - RN9 documented that at 6:11 AM the patient’s blood pressure was 181/106 mm/Hg. - RN9 documented that at 7:31 AM the patient’s blood pressure was 191/108 mm/Hg. - RN7 documented that at 8:04 AM the patient’s blood pressure was 215/97 mm/Hg. - RN7 documented that at 8:32 AM the patient’s blood pressure was 212/117 mm/Hg. - RN7 documented that at 9:02 AM the patient’s blood pressure was 193/103 mm/Hg. - RN7 documented that at 9:35 AM the patient’s blood pressure was 205/105 mm/Hg. - RN9 documented that at 10:01 AM the patient’s blood pressure was 207/108 mm/Hg. - RN9 documented that at 10:09 AM the patient’s blood pressure was 210/108 mm/Hg. Further review revealed there was no evidence of RN notification to the provider of the out-of-range vital signs. Review of P3’s “Treatment Sheet for Facility,” dated 04/14/2025, revealed PCT4 documented that at 6:32 AM the patient’s blood pressure was 191/105 mm/Hg, and at 7:02 AM it was 207/112 mm/Hg. Further review revealed there was no evidence of RN notification to the provider of the out-of-range blood pressure. Review of P3’s “Treatment Sheet for Facility,” dated 04/16/2025, revealed RN6 documented the following: - At 5:54 AM the patient’s blood pressure was 181/98 mm/Hg. - At 5:55 AM the patient’s blood pressure was 183/97 mm/Hg. - At 6:00 AM the patient’s blood pressure was 187/102 mm/Hg. - At 7:02 AM the patient’s blood pressure was 184/104 mm/Hg. Further review revealed there was no evidence of RN notification to the provider of the out-of-range blood pressures. The treatment sheet revealed PCT3 documented that at 6:31 AM the patient’s blood pressure was 173/102 mm/Hg. There was no evidence of RN notification to the provider of the out-of-range blood pressure. 4. Review of P4’s “Treatment Sheet for Facility,” dated 04/09/2025, revealed RN6 documented they discharged the patient with a blood pressure reading of 94/52 mm/Hg. Further review revealed there was no evidence that RN6 notified the provider of the out-of-range blood pressure. Review of P4’s “Treatment Sheet for Facility,” dated 04/11/2025, revealed the section titled, “Special Attentions” included an order for “okay to continue treatment and keep ultrafiltration (UF) on if systolic bp [blood pressure] is 90 or greater and diastolic 40 or greater.” The treatment sheets revealed that RN8 documented the following: - At 9:33 AM the patient’s blood pressure was 91/48 mm/Hg. - At 9:36 AM the patient’s blood pressure was 91/56 mm/Hg. - At 9:44 AM the patient’s blood pressure was 96/51 mm/Hg. - At 10:06 AM the patient’s blood pressure was 84/50 mm/Hg. - At 10:12 AM the patient’s blood pressure was 109/43 mm/Hg. - At 10:42 AM the patient’s blood pressure was 92/51 mm/Hg. Further review revealed there was no evidence of RN notification to the provider of the out-of-range blood pressures. Review of P4’s “Treatment Sheet for Facility,” dated 04/14/2025, revealed the section titled, “Special Attentions” included an order for “okay to continue treatment and keep UF on if systolic bp is 90 or greater and diastolic 40 or greater.” The treatment sheet revealed RN7 documented the following: - At 9:03 AM the patient’s blood pressure was 70/43 mm/Hg. - At 9:04 AM the patient’s blood pressure was 91/56 mm/Hg. - At 9:44 AM the patient’s blood pressure was 96/51 mm/Hg. - At 10:06 AM the patient’s blood pressure was 84/50 mm/Hg. - At 10:12 AM the patient’s blood pressure was 101/57 mm/Hg. - At 9:34 AM the patient’s blood pressure was 100/58 mm/Hg. - At 10:55 AM the patient’s blood pressure was 89/46 mm/Hg. - At 10:55 AM the patient’s blood pressure was 82/50 mm/Hg. - At 10:59 AM the patient’s blood pressure was 88/52 mm/Hg. The treatment sheet revealed RN9 documented that at 10:02 AM the patient’s blood pressure was 90/58 mm/Hg. Further review revealed there was no evidence of RN notification to the provider of the out-of-range vital signs. 5. Review of P5’s “Treatment Sheet for Facility,” dated 04/09/2025, revealed the section titled, “Special Attentions” included an order for “per [provider name] may start patient with a blood pressure less than equal to 200 systolic and 100 diastolic.” The treatment sheet revealed PCT2 documented that at 9:43 AM the patient’s blood pressure was 222/92 mm/Hg, and at 9:47 AM it was 215/157 mm/Hg. The treatment sheet revealed the PCT started the patient’s treatment at 9:47 AM, when the patient’s blood pressure reading was outside of the ordered parameters. Further review revealed there was no evidence of the PCT notifying an RN of the out-of-range blood pressures. Review of P5’s “Treatment Sheet for Facility,” dated 04/09/2025, revealed PCT2 documented that at 11:31 AM the patient’s blood pressure was 190/84 mm/Hg, and at 12:34 PM it was 237/110 mm/Hg. The treatment sheet revealed PCT1 documented that at 10:30 AM the patient’s blood pressure was 222/91 mm/Hg. The treatment sheet revealed PCT4 discharged the patient at 12:48 PM with a blood pressure reading of 226/95 mm/Hg. Further review revealed there was no evidence the PCT1, PCT2, or PCT4 notified an RN of the out-of-range blood pressures. Review of P5’s “Treatment Sheet for Facility,” dated 04/09/2025, revealed RN7 documented the following: - At 10:02 AM the patient’s blood pressure was 234/94 mm/Hg. - At 10:14 AM the patient’s blood pressure was 207/98 mm/Hg. - At 10:24 AM the patient’s blood pressure was 229/98 mm/Hg. - At 12:00 PM the patient’s blood pressure was 223/97 mm/Hg. Further review revealed there was no evidence the RN notified the provider of the out-of-range blood pressures. Review of P5’s “Treatment Sheet for Facility,” dated 04/11/2025, revealed the section titled, “Special Attentions” included an order for “per [providers name] may start patient with a blood pressure less than equal to 200 systolic and 100 diastolic.” The treatment sheet revealed RN6 documented that at 9:30 AM the patient’s blood pressure was 232/108 mm/Hg, and at 9:36 AM it was 243/103 mm/Hg. The treatment sheet revealed the RN started the patient’s treatment at 9:36 AM, when the patient’s blood pressure reading was outside of the ordered parameters. Further review revealed there was no evidence the RN notified the provider of the out-of-range blood pressures. Review of P5’s “Treatment Sheet for Facility,” dated 04/11/2025, revealed no evidence of patient vital signs from 10:03 AM to 11:01 AM (58 minutes). Review of P5’s “Treatment Sheet for Facility,” dated 04/11/2025, revealed PCT5 documented that at 11:01 AM the patient’s blood pressure was 240/97 mm/Hg, and at 11:32 AM it was 223/108 mm/Hg. The treatment sheet revealed PCT10 documented that at 12:04 PM the patient’s blood pressure was 237/110 mm/Hg, and at 12:29 PM it was 230/121 mm/Hg. Further review revealed there was no evidence PCT5 or PCT10 notified an RN of the out-of-range blood pressures. Review of P5’s “Treatment Sheet for Facility,” dated 04/11/2025, revealed RN6 documented that at 12:04 PM the patient’s blood pressure was 237/102 mm/Hg, and at 12:29 PM it was 230/102 mm/Hg. Further review revealed there was no evidence the RN notified the provider of the out-of-range blood pressures. Review of P5’s “Treatment Sheet for Facility,” dated 04/16/2025, revealed no evidence of patient vital signs from 10:02 AM to 11:02 AM (60 minutes). During an interview on 04/25/2025 at 12:17 PM, PCT5 stated patients were checked every 30 minutes, and it could be more frequently if needed based on the patient’s condition. PCT5 stated the RN should be notified for blood pressure changes or if there were any patient complaints such as nausea, lightheadedness, hot, sweaty, etc. (et cetera; and so forth). PCT5 stated the RN notification should be documented along with any interventions done. During an interview on 04/23/2025 at 12:20 PM, RN8 stated PCTs were to report out-of-range blood pressures, and anything abnormal for the patient and their access. RN8 stated the PCTs should report systolic blood pressures greater than 180 and less than 100, diastolic blood pressures less than 50 or greater than 90, and heart rates greater than 100 or less than 60. RN8 stated the PCTs were good at reporting to the RNs. RN8 also stated that PCTs should document any time they notified an RN. RN8 stated the RN should then follow-up and document their follow-up. During an interview on 04/24/2025 at 2:20 PM, the Clinic Manager (CM) stated the facility expected vital signs, including blood pressure and heart rate, to be recorded every 30 minutes. During additional interview on 04/24/2025 at 5:02 PM, the CM stated the facility expectation that staff should still report out-of-range vital signs, even if there were special attention parameters. During additional interview on 04/24/2025 at 5:26 PM, the CM stated the facility expected PCTs to notify an RN every time there was an abnormal finding. During an interview on 04/25/2025 at 3:43 PM, the Medical Director stated staff should call the provider for any patient outliers such as a patient run on the wrong dialysate bath, fluid gain of more than two to three kilograms, patients who lost weight and might need a change to their dry weight, or patients with a systolic blood pressure reading higher than 160 or below 100. The Medical Director stated the facility’s expectation was that PCTs report to RNs per the facility’s policy and for RNs to report to the provider.”

“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: 50873 Based on interview, record review, and facility policy review, the facility failed to ensure patients’ dialysis prescriptions were delivered as ordered for 5 of 7 patients in the medical record review sample, Patient (P) 1, P2, P4, P5, and P6. The findings include: Review of the facility’s policy titled, “Patient Assessment and Monitoring,” published 05/01/2023, indicated that monitoring patient and machine parameters during treatment should include, “Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered.” 1. Review of P1’s “Treatment Sheet,” dated 04/08/2025, revealed the patient’s dialysis machine was set for a blood flow rate (BFR) of 300 from 5:41 AM until 6:36 AM. The dialysis prescription indicated the BFR should have been set for 450. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. Review of P1’s “Treatment Sheet,” dated 04/15/2025, revealed the patient’s dialysis machine was set for a BFR of 400 from 6:32 AM until 9:30 AM. The dialysis prescription indicated the BFR should have been set for 450. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. Review of P1’s “Treatment Sheet,” dated 04/17/2025, revealed the patient’s dialysis machine was set for a BFR of 400 from 6:00 AM until 9:17 AM. The dialysis prescription indicated the BFR should have been set for 450. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. 2. Review of P2’s “Treatment Sheet,” dated 04/19/2025, revealed the patient’s dialysis machine was set for a blood flow rate (BFR) of 220 from 10:30 AM until 11:04 AM, was increased to 350 until 11:30 AM, was increased to 400 at 11:30 AM, and then was decreased to 350 from 12:01 PM until 1:16 PM. The dialysis prescription indicated the BFR should have been set for 400. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. 3. Review of P4’s “Treatment Sheet,” dated 04/07/2025, revealed the patient’s dialysis machine was set for a blood flow rate (BFR) of 300 from 6:46 AM until 7:31 AM. The dialysis prescription indicated the BFR should have been set for 450. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. Review of P4’s “Treatment Sheet,” dated 04/14/2025, revealed the patient’s dialysis machine was set for a dialysate flow rate (DFR) of 800 from 6:48 AM until 10:03 AM. The dialysis prescription indicated the DFR should have been set for 500. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. 4. Review of P5’s “Treatment Sheet,” dated 04/07/2025, revealed the patient’s dialysis machine was set for a blood flow rate (BFR) of 300 from 9:40 AM until 12:01 PM, and was then increased to 400 until 12:32 PM. The dialysis prescription indicated the BFR should have been set for 450. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. Review of P5’s “Treatment Sheet,” dated 04/09/2025, revealed the patient’s dialysis machine was set for a BFR of 300 from 9:47 AM until 10:02 AM, and then the patient’s treatment was paused so the patient could go to the bathroom. Upon resumption of treatment at 10:24 AM, the BFR was set for 300 until 11:31 AM, when it was increased to 400 until 12:00 PM. The dialysis prescription indicated the BFR should have been set for 450. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. 5. Review of P6’s “Treatment Sheet,” dated 04/07/2025, revealed the patient’s dialysis machine was set for a blood flow rate (BFR) of 300 from 10:57 AM until 12:01 PM. The dialysis prescription indicated the BFR should have been set for 450. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. Review of P6’s “Treatment Sheet,” dated 04/11/2025, revealed the patient’s dialysis machine was set for a BFR of 400 from 11:32 AM until 1:33 PM. The dialysis prescription indicated the BFR should have been set for 450. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. Review of P6’s “Treatment Sheet,” dated 04/18/2025, revealed the patient’s dialysis machine was set for a dialysate flow rate (DFR) of 800 from 10:31 AM until 1:50 PM. The dialysis prescription indicated the DFR should have been set for 500. The record revealed no evidence of documentation that provided a rationale for the deviation from the patient’s dialysis prescription. During an interview on 04/24/2025 at 2:20 PM, the Clinical Manager stated there was no reason a patient’s dialysate flow rate should ever differ from the prescription. During an interview on 04/24/2025 at 12:17 PM, Patient Care Technician (PCT) 5 stated, if a staff member noticed a patient’s BFR was not running as ordered, the staff member was to notate the reason, correct it, and notify a nurse. PCT5 stated any changes a staff member made needed to be charted and reported to a nurse. During an interview on 04/23/2025 at 12:20 PM, Registered Nurse (RN) 8 stated, if there were discrepancies between a BFR and what was prescribed, staff documented the reason and notified a provider. During an interview on 04/25/2025 at 3:43 PM, the Medical Director stated it was their expectation that all treatments followed the dialysis prescription and, if any deviations were made from the prescription, those should be documented along with a rationale.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 50873 Based on observation, interview, and facility policy review, the facility failed to provide vascular access monitoring per the facility’s policy for 2 out of 2 observations of initiation of dialysis for patients with an arteriovenous fistula (AVF). The findings include: Review of the facility’s policy titled, “Access Assessment and Cannulation,” published on 05/06/2024, revealed “Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session.” Further review revealed, “LISTEN: Bruit high pitch/whistle; Bruit not present throughout access” and “Document in treatment record; NOTE: Staff/patients/care partners who have been trained to auscultate vascular accesses should listen to the entire length of the access for changes in the sound of the bruit.” Further review revealed, “Note and report any unusual findings to the nurse in charge or home therapies staff before proceeding with needle insertion.” 1. Observation on 04/23/2025 at 10:15 AM, revealed Patient Care Technician (PCT) 5 was in Patient Treatment Station 1 initiating dialysis treatment for a patient with an arteriovenous fistula (AVF). PCT5 performed hand hygiene, donned gloves, cleaned the access site with soap and water, performed hand hygiene again and changed gloves, applied a tourniquet, touched the access site to show the patient where to apply a numbing spray, and then cannulated the access site. PCT5 failed to auscultate (listen with a stethoscope) the access site prior to cannulation. 2. Observation on 04/23/2025 at 11:03 AM, revealed PCT3 was in Patient Treatment Station 12 initiating dialysis treatment for a patient with an AVF. PCT3 performed hand hygiene, donned gloves, cleaned the access site with soap and water, performed hand hygiene again and changed gloves, applied a tourniquet, touched the access site to show the patient where to apply a numbing spray, and then cannulated the access site. PCT3 failed to auscultate the access site prior to cannulation. During an interview on 04/23/2025 at 3:31 PM, PCT3 stated they did not auscultate the patient’s access prior to cannulation. PCT3 stated, if an access did not feel “real good” while washing it, they further assessed the site. PCT3 defined “real good” as feeling a strong pulse through the access. PCT3 stated, in the past, staff was supposed to auscultate access sites, but noted that was no longer the case. During an interview on 04/24/2025 at 12:17 PM, PCT5 stated staff was supposed to auscultate a patient’s access site prior to cannulation, but she was “bad to forget” to do so. During an interview on 04/25/2025 at 9:00 AM, the Medical Director stated auscultating a patient’s access should be done prior to cannulating an access site.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 50873 Based on interview and facility document and policy review, the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to analyze benchmark data and identify trends, which had a potential negative impact for all 62 patients who received dialysis treatment at the facility. The findings include: Review of the facility’s policy titled, “Quality Assessment and Performance Improvement (QAPI) for Inpatient Services,” with a publication date of 05/06/2024, indicated, “The purpose of the QAPI Program is to ensure continuous quality assurance and performance improvement. Quality assurance activities include identification, assessment, correction, and monitoring of important aspects of patient care designed to enhance the quality of care provided.” Review of the facility’s document “Trends: Crude Mortality Rate,” for the time period from April 2024 to March 2025, revealed a trend of an increasing crude mortality rate from September 2024 to February 2025. The document revealed a total of 19 patient deaths. Further review of the document revealed that potential contributing factors were documented and identified that 12 patients of the 19 who died during this time period had a one-month average treatment time of less than four hours, and nine of the 19 patients had a central venous catheter (CVC). The document revealed that sections of the document titled “Notes,” “Current Action Plan,” and “Previous Action Plan” all indicated there were “none.” During an interview on 04/25/2025 at 7:23 PM, the Clinic Manager (CM) stated the facility failed to identify any trends for mortality. The CM indicated that potential trends should have been investigated since nine of 19 patients who died had CVCs and 12 of the 19 patient deaths had a one-month average treatment time of less than four hours. The CM stated that no trends were identified, and no action plan was created. During an interview on 04/25/2025 at 3:43 PM, the Medical Director stated the interdisciplinary team (IDT) thoroughly discussed and reviewed every metric during their monthly QAPI meetings. The Medical Director stated he was not aware of the process for recording the meeting minutes in order for the facility to demonstrate regulatory compliance, but he intended to follow-up.”