Portage Dialysis Center

“Establishment of the EP Program Dialysis CFR(s): §494.62 Condition for Coverage: The dialysis facility must comply with all applicable Federal, State, and local emergency preparedness requirements. These emergencies include, but are not limited to, fire, equipment or power failures, care related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. The dialysis facility must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: 42524 Based on record review and interview, the dialysis clinic failed to evidence documentary evidence they developed and maintained an emergency plan specific for this clinic, that included a communication plan that complied with federal, state, and local laws, and was reviewed every 2 years (See E0029), failed to develop and maintain an emergency preparedness communication plan that included primary and alternate means for communication with the staff, federal, state, tribal, regional, and local emergency management (See E0032), and failed to evidence a method / process for sharing information and medical documentation for their patients under the clinic’s care with other health care providers to maintain continuity of care, and in the event of an evacuation, a means of releasing patient information about the general condition and location of their patients (See E0033). The cumulative effect of these systemic problems resulted in the Dialysis Centers’ inability to ensure the provision of quality health care in a safe environment and resulted in the agency being found out of compliance with condition 42 CfC 494.62 Emergency preparedness. The finding include: 1. The policy with revision date 6/2022 and titled, “Disaster and Emergency Preparedness,” was provided for review. The policy indicated a communication plan will be defined that established how associates and patients will be notified of emergency conditions at the center. 2. A review of the clinic’s emergency preparedness plan on 12/13/23, failed to evidence documentation of a communication plan that complied with the federal, state, and local laws to include a method for sharing medication documentation for their patients under the care of the clinic, failed to evidence a plan for the primary and alternate means for informing local, state, federal, and / or tribal officials of their patients and their specific medical care needs, that the provider was unable to reach, patients in need of evacuation, or on - duty staff that the agency was unable to contact. 3. During an interview on 12/15/23, beginning at 12:45 PM, the Facility Administrator (FA) indicated the plan was developed to prepare for severe weather and/or water issues requiring the closing of the center The FA indicated the agency did not develop and include to utilize volunteers for any patient care. When queried about the communication plan and how they would communicate during an emergency, the FA called corporate and printed a new policy and then said the policy was what they were to be currently using. The document was provided for review. The document was an outline / template of what all the clinic’s would need to initiate in their emergency plan policies and procedures. In a follow up interview, the FA indicated she did not see an actual clinic plan included in the documents provided. The FA indicated she would use the phone call tree to call everyone to ensure communication in an emergency situation. The FA indicated the clinic did not have an emergency preparedness communication plan that included primary and alternate means for communication, though they have a red phone on the dialysis floor that works through the fax phone lines and will always work in an emergency. She indicated she always had her computer with her so she has access to the patient’s records. The FA indicated if a patient needed to go to another center in an emergency the centers in their corporation could access the patient records and if they had to send outside of their corporation, they would fax over the patient records. At 2:20 PM, the FA indicated the clinic did not have a procedure to share patient medical documentation indicated other corporate clinics would have access to their patient information and if they needed to get the information to an outside agency, they would / could fax the information to them.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 42524 Based on observation, record review, and interview the dialysis center failed to ensure staff maintained a sanitary environment (V111), failed to performed proper hand hygiene (V113), failed to use proper protective equipment (V115), failed to ensure items taken to the dialysis station were disinfected (V116) failed to ensure dialysis stations were disinfected appropriately (V122), failed to ensure the staff practiced, infection control standards in the administration of medication using of muti-dose medication vials (V143) and failed to ensure catheter hubs were disinfected (V147). The cumulative effect of these systemic problems has resulted in the dialysis center’s inability to ensure provision of quality health care in a safe environment for the condition of participation 42CFC 494.30. Infection Control.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 42524 Based on observation, record review, and interview, the dialysis facility failed to ensure staff implemented the facility’s policy and procedures for treatment of hypertension/hypotension, including failure to the nephrologist, failure to notify the registered nurse of elevated blood pressures for 2 of 2 (Patients #1, #2) clinical records reviewed and 4 of 4 observations of patients with abnormal blood pressures (Patients (8, #9, #10 #11) . This immediate jeopardy had the potential to affect all patients of the dialysis center. Based on record review, observation, and interview, the dialysis center failed to ensure the interdisciplinary team assessed and met the needs of patients, failed to ensure the appropriateness of dialysis prescriptions (See V503) and failed to ensure blood pressure and fluid management needs were met (See V504). The cumulative effect of these systemic problems has resulted in the dialysis center’s inability to ensure the provision of quality health care in a safe environment for the condition of participation 42CFR 494.80 Patient Assessment. The findings include: 1. A record review evidenced an agency policy received on 12/14/2023, titled “Charge Nurse Notification Protocol,” indicated the nurse should be notified of pretreatment systolic blood pressures (SBP) of >200 or < 90 and Diastolic BP > 100 or <50 and weight gain > 3 kilograms (kg), shortness of breath swelling of legs, face, or ankles. During treatment, the nurse should be notified of SBP > 160 or < 90. Pulse >100 or < 60 chest pain, discomfort, shortness of breath, and any change from initiation of treatment. Post treatment the nurse should be notified of SBP > 160 or < 90. Pulse >100 or < 50 chest pain discomfort shortness of breath and any change from initiation of treatment, SBP drops of 25 points or more, and DBP drops of 15 points or more. 2. A record review evidenced an agency policy revised 9/1/2023, titled “Patient Assessment Pre & Post Dialysis indicated the nurse responsible will be notified if the vital signs are not within normal limits. If the patient is a new admission and has not been treated in the center previously a Registered Nurse (RN) must perform and document the full pre-dialysis assessment before the initiation of the first treatment to identify and address any problems that may prohibit or complicate the dialysis treatment. The nurse responsible for the patient will be immediately notified whenever the patient’s vital signs are not within normal limits for that patient or reach any alert values. 3. A clinical record review for Patient #1, start of care 4/24/2017, included a review of the Dialysis Treatment Flowsheets, dated 8/11/2023 through 9/8/20232 and evidenced the following: On 8/11/2023, the documentation evidenced Patient #1’s BP prior to starting treatment was 159/93; at 9:59 AM, BP was 143/114 and pulse was 129. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders. On 8/14/2023, the documentation evidenced Patient #1’s BP prior to starting treatment was 163/100; at 9:59 AM, BP was 163/100. Patient # 1 Estimated dry weight (EDW) was 123 kilograms (kg), pre-weight was 128.5 kg and post-weight was 124.5 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 8/16/2023, the documentation evidenced Patient #1’s BP at 12:02 PM was 89/62; at 12:04 PM, BP was 93/54. Patient #1’s EDW was 123 kilograms kg; pre-weight was 129.8 kg and post-weight was 125.4 kg. Post assessment completed by RN 2 indicated Patient #1 had +2 (3-4mm of depression, rebounding in 15 seconds or less) edema (swelling caused by too much fluid trapped in the body’s tissues) to legs and had fluid overload. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 8/18/2023, the documentation evidenced Patient #1’s BP at 11:03 AM was 141/50; at 11:32 AM, BP was 113/49; Patient #1’s EDW was 123 kg, pre-weight was 128.7 kg and post-weight was 125.6 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 8/21/2023, the documentation evidenced Patient #1’s pretreatment BP was 206/118; at 9:37 AM was 189/108; at 10:29 AM, BP was 174/101; at 10:49 AM, BP was 171/106; at 10:53 AM, BP was 141/100. Patient #1’s EDW was 123 kg; pre-weight was 131.3 kg and post-weight was 127.3 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 8/23/2023, the documentation evidenced Patient #1’s pretreatment BP was 197/104; at 9:11 AM was 172/102; at 11:29 AM, BP was 141/57; at 12:59 AM, BP was 90/67; at 10:53 AM, BP was 141/100. Patient #1’s EDW was 123 kg; pre-weight was 129 kg and post-weight was 126.1 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 8/25/2023, the documentation evidenced Patient #1’s EDW was 123 kg; pre-weight was 128.5 kg and post-weight was 124.9 kg. post treatment sitting BP was 142/82 and standing was 103/82. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 8/28/2023, the documentation evidenced Patient #1’s pretreatment BP was 179/107; at 10:01 AM was 148/102; at 10:59 AM, BP was 154/102; at 12:59 PM, BP was 90/67; at 10:53 AM, BP was 141/100. Patient #1’s EDW was 123 kg; pre-weight was 130.3 kg and post-weight was 125.7 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 8/30/2023, the documentation evidenced Patient #1’s BP at 9:31 AM was 154/104; at 10:29 AM, BP was 151/106; at 11:59 AM, BP was 138/103. Patient #1’s EDW was 123 kg; pre-weight was 129.5 kg and post-weight was 125.3 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 9/1/2023, the documentation evidenced Patient #1’s BP at 12:29 PM was 98/76 Patient #1’s EDW was 123 kg; pre-weight was 129.3 kg and post-weight was 125.3 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 9/4/2023, the documentation evidenced Patient #1’s pre-treatment BP was 166/122; BP at 8:57 AM was 175/149; at 8:59 AM, BP was 163/102; at 9:29 AM, BP was 164/101; BP at 9:59 AM was 162/121; BP at 11:59 AM was 168/108; post-treatment standing BP was 182/99 and standing was 145/96. Patient #1’s EDW was 123 kg; pre-weight was 130.3 kg and post-weight was 126.1 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 9/8/2023, the documentation evidenced Patient #1’s pre-treatment BP was 189/107; BP at 9:09 AM was 170/99; BP at 9:29 AM was 155/109; BP at 10:59 AM was 206/90; BP at 12:59 PM was 160/103; post-treatment sitting BP was 147/85 and standing was 170/100. Patient #1’s EDW was 123 kg; pre-weight was 131.3 kg and post-weight was 126.1 kg. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. During an interview on 12/12/2023 at 11:05 AM, Person #1 indicated Patient #1 missed a dialysis treatment on 9/11/2023 due to transportation not arriving to take Patient #1 to dialysis. Person indicated that Patient #1 called 911 due to shortness of breath. Patient #1 was taken to Entity 1 on 9/12/2023 via 911 and was admitted to intensive care on life support. Person 1 indicated life support was removed on 9/15/2023 and Patient #1 passed away. During an interview on 12/13/2023 at 9:30 AM, the Medical Social Worker indicated Patient #1 did not come to treatment on 9/11/2023 due to a transportation issue. Transportation was confirmed for 9/13/2023 and 9/15/2023 and she was unsure why there was no transportation for 9/11/2023. She indicated Patient #1 went to the hospital on 9/12/2023 and passed away. During an interview on 12/13/2023 at 10:38 AM, the clinical manager indicated Patient #1 did not come to treatment on 9/11/2023 because he/she did not have a ride. The Clinical Manager indicated Patient #1 was set up for transportation for the remainder of the week, but she did not know Patient #1 needed transportation on 9/11/2023. 4. A clinical record review for Patient #2, start of care 11/11/2023, included a review of the Dialysis Treatment Flowsheets, dated 11/11/2023 through 11/16/2023 and evidenced the following: On 11/11/2023, the documentation evidenced Patient #2’s pre-treatment BP was 110/58: BP at 11:57 AM was 110/55; at 12:29 PM, BP was 102/56; at 12:59 PM, BP was 92/47; at 1:00 PM, BP was 87/59; at 1:04 PM, BP was 86/57; at 1:30 PM, BP was 81/52; at 1:49 PM, BP was 102/53; at 1:59 PM, BP was 86/51; 2:29 PM, BP was 96/54 and at 2:31 PM, BP was 104/53. The post-assessment completed by RN 1 indicated Patient #2 had shortness of breath post-treatment. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 11/14/2023, the documentation evidenced Patient #2’s pre-treatment BP was 89/52: BP at 11:05 AM, was 56/40; at 11:07 AM, BP was 47/29; at 11:09 AM, BP was 70/39; at 11:10 AM, BP was 70/29; at 11:12 AM, BP was 78/43; at 11:15 AM, BP was 74/26; at 11:17 AM, BP was 107/38; at 11:32 AM, BP was 40/23; at 12:02 PM, BP was 73/44; at 12:31 PM, BP was 89/47; at 1:32 PM, BP was 98/40; at 2:02 PM, BP was 91/48; at 2:31 PM, BP was 87/58; at 1:59 PM, BP was 86/51; 2:29 PM, BP was 96/54. The post-assessment completed by RN 2 indicated Patient #2 had +2 pitting edema in the lower extremities. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 11/16/2023, the documentation evidenced Patient #2’s pre-treatment BP was 85/45; at 11:07 AM, BP was 90/43; at 11:20 AM, BP was 91/38; at 11:32 AM, BP was 88/41; at 11:47 AM, BP was 69/49; at 12:01 PM, BP was 66/60; at 12:10 PM, BP was 94/50; at 12:17 PM, BP was 92/52; at 12:31 PM, BP was 93/45; at 12:47 PM, BP was 99/89; at 1:02 PM, BP was 74/36; at 1:31 PM, BP was 88/44; at 2:19 PM, BP was 82/60; at 2:40 PM, BP was 87/49; 2:42 PM, BP was 75/57; and post-treatment BP was 91/52. The post-assessment completed by RN 1 indicated Patient #2 had rales (abnormal breath sounds) and wheezing (abnormal breath sounds) and the patient remained fluid overload due to not being able to pull fluid. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. Documentation failed to indicate the Physician was notified of Patient #2’s condition. A review of documentation from Entity 2 (Skilled Nursing Facility) indicated Patient #2 was found unresponsive at 10:20 AM in his room, CPR was started, and EMS was called Patient #2 expired at 10:55 AM. During an interview on 12/13/2023 at 11:24 AM, the clinical manager indicated there is no policy to call the Physician, but the nurse should notify the Physician for anything out of normal range for the Patient. During an interview on 12/13/2023 at 3:15 PM, the clinical manager indicated they could not get fluid off Patient #2 due to low blood pressure. She indicated Patient #2 was sick and should never have left the hospital. During an interview on 12/14//2023 at 2:00 PM, RN 1 indicated the Nurse Practitioner was aware of Patient 2’s low blood pressure and was ordering Midodrine (for low blood pressure), but Patient #2 passed away before the medication could be started. During an interview on 12/15/2023, at 2:24 PM, the Medical Director indicated longer treatments should have been recommended or 1 additional treatment. Hold any blood pressure medications and if the Patient had an order for Midodrine they could bring that with them to take while at the dialysis center. During an interview on 12/15/2023 at 3:25 PM, the Clinical Manager indicated the Physician would not have been notified of the Patient #2’s edema because that is normal for a new patient. She indicated the Physician should have been notified of the low blood pressure, but Patient #2 was always alert and oriented during treatment. 42909 5. Patient #8 was observed on the treatment floor on 12/12/2023, from 9:53 AM - 12:07 PM, which revealed the following: At 10:02 AM, Patient #8’s dialysis treatment preparation was initiated by PCT 1. At 10:07 AM, Patient #8’s blood pressure was 83/44, and pulse was 52. At 10:07 AM, Patient #8’s blood pressure was 94/34, and pulse was 49. At 10:16 AM, Patient #8’s blood pressure was 70/28, and pulse was 48. At 10:19 AM, RN 1 asked Patient #8 if his/her blood pressure always ran low, the patient replied it has been running low, and RN 1 failed to provide interventions to mitigate the low blood pressure. At 10:50 AM, Patient #8’s dialysis machine recorded blood pressure and pulse, obtained at 10:30 AM, was 108/35 and pulse 49. At 11:01 AM, Patient #8’s blood pressure was 92/36, and pulse was 46. At 11:04 AM, PCT 4 informed RN 1 that Patient #8’s blood pressure was still low. PCT 1 and PCT 4 left the treatment floor. RN 1 failed to assess the patient. At 11:31 AM, Patient #8’s dialysis machine alarmed for blood pressure of 111/43, and pulse 49. At 12:06 PM, Patient #8’s blood pressure was 125/22, and pulse was 50. At 12:07 PM, RN 1 and PCT 1 discussed Patient #8’s low blood pressure, and neither provided mitigation for the low blood pressure. Patient #8 was observed on the treatment floor on 12/12/2023, from 2:26 PM - 2:46 PM, which revealed the following: At 2:26 PM, Patient #8 complained to PCT 4 of nausea, dizziness, felt like he/she was going to vomit, indicated his/her dialysis treatment ended at 1:30 PM, he/she was left sitting in the wheelchair since that time, and dialysis facility staff should have left her in the treatment chair until transportation arrived because he/she had a bed sore and was in terrible pain. Patient #8 indicated she was diabetic, and hadn’t eaten since breakfast. PCT 4 notified RN 1. RN 1 indicated that’s just how Patient #8 was, and failed to assess or mitigate symptoms. At 2:46 PM, the Clinical Manager entered the treatment area, and asked if there was a problem with Patient #8. The Clinical Manager indicated a patient’s blood sugar should be checked if symptoms (include but not limited to dizziness, nausea) were present. At 2:46 PM, The Clinical Manager gave Patient #8 a protein bar and walked away. PCT 4 obtained the patient’s blood pressure (139/56), and the patient indicated her blood sugar was probably low, but the protein bar should help. The patient’s blood sugar was not checked. The clinical record for Patient #8 included a dialysis treatment sheet dated 12/12/2023, which indicated treatment was initiated at 10:30 AM, and ended at 1:30 PM. The sheet evidenced RN 1 assessed the patient at 10:04 AM, and the patient had no nausea/vomiting. RN 1 assessed the patient again at 1:47 PM, and the patient had no nausea/vomiting. The initial nursing assessment dated 12/02/2023, failed to evidence home medications or history and physical were reviewed. A dialysis practitioner visit note dated 12/05/2023 indicated no home record of medications was found. A dialysis practitioner visit note dated 12/12/2023 indicated medications included but not limited to a catapres patch (to lower blood pressure), clonidine as needed (to lower blood pressure) isosorbide mononitrate (to lower blood pressure), and nifedipine (to lower blood pressure). Nurse Practitioner (NP) 1 identified that Patient #8’s medications needed to be reviewed, as he/she was coming in with systolic (top/first number of blood pressure reading) pressures of 90-100. Within the note, there was a box to check, to confirm the clinician reviewed and/or changed medications. The box was not checked. During an interview on 12/14/2023 at 10:21 AM, the Clinical Manager indicated initial plans of care/comprehensive assessments could be completed sooner than the regulatory requirement if there was a need. During an interview on 12/14/2023 at 1:56 PM, RN 1 indicated Patient #8’s first dialysis treatment occurred on 12/02/2023, and the initial plan of care/comprehensive assessment wasn’t completed because it wasn’t due yet. During an interview on 12/14/2023 at 1:56 PM, RN 1 indicated Patient #8 was confused sometimes, and would complain that his/her blood sugar was low sometimes, when it really wasn’t. RN 1 indicated she was caring for another patient when Patient #8 complained of nausea and dizziness on 12/12/2023. During an interview on 12/14/2023 at 2:40 PM, the Dietician indicated they didn’t usually do the initial plan of care or initial comprehensive assessment any sooner that the 30 day/13 treatment requirement. During an interview 12/15/2023 at 1:54 PM, the Medical Director indicated the types of situations that would necessitate the initial plan of care and comprehensive assessment to be completed prior to the 30 day/13 treatment requirement included but not limited to if the patient was having some issues. Surveyor: Hopkins, Susan 6. During a floor observation on 12/11/2023 at 1:30 PM, RN 1 discontinued Patient #11’s dialysis treatment. Patient #11’s blood pressure at that time was 206/99. A recheck at 1:34 PM evidenced a blood pressure of 202/96. During an interview on 12/11/2023 at 1:52 PM, RN 1 indicated Patient #11 always has high blood pressure and refused to take their blood pressure medication prior to dialysis, therefore, always runs high. RN 1 indicated Patient #11 never has low blood pressure. When asked, RN 1 indicated the physician would possibly be notified of Patient #11’s high blood pressure if the systolic pressure was 230 or above. RN 1 indicated other interventions would be reducing fluid, but Patient #11 gets cramps if systolic blood pressure was below 144. During an interview on 12/12/2023 at 11:20 AM, Clinical nurse specialist (CNS, a type of advance practice nurse) 1 indicated Patient #11 always has high blood pressure during dialysis and was noncompliant with blood pressure medications. CNS 1 indicated the CNS and MD both knew what was typical for Patient #11’s blood pressure, so did not expect to be notified when it was high. When asked about individualized parameters for Patient #11, CNS 1 indicated there was nothing specifically identified as to when to notify them of high blood pressure. 7. During an observation period on 12/12/2023, Patient #9 was on dialysis at 11 AM. The blood pressure reading at that time was 101/39. At 11:30 AM the reading was 86/42. A recheck of the blood pressure at 11:39 AM read 101/39. At 11:44 AM, PCT 4 checked on Patient #9 by calling their name. Patient #9 answered saying they were just trying to breathe through the nose (patient had oxygen tubing in the nostrils). At 11:46 AM, PCT 4 readjusted the blood pressure cuff with a blood pressure of 86/33. After another readjustment of the blood pressure cuff, the blood pressure read 70/33. PCT 4 asked if Patient #9 was doing OK, the response was “I guess.” At 11:50 AM, blood pressure was 87/41. At that time PCT 4 gave Patient #9 additional fluid. 8. During an observation period on 12/12/2023 PCT 4 prepared Patient #10 for the initiation of dialysis at 10:52 AM. Patient #10’s blood pressure was abnormal, so PCT 4 rechecked the blood pressure, which was 81/56. RN 2 was called over by PCT 4. RN 2 readjusted the cuff and checked the blood pressure again with a result of 71/54. RN 2 moved the blood pressure cuff to the patient’s ankle and received a reading of 44/31. RN 2 indicated patient arrives below their dry weight (estimated weight of the person, excluding the additional fluid gained between dialysis treatments), so the low blood pressure may be correct. At 11:10 AM blood pressure was 102/63. At 11:15 AM, blood pressure was 95/63 and 88/34 at 11:30 AM. 9. During an interview on 12/14/2023 at 2:45 PM, RN 2 indicated they treat the patient, not the machine blood pressure readings. RN 2 indicated if the patient was alert and talking, it was more important to remove the fluid than manage the blood pressure. 44714”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 42909 Based on observation, record review, and interview, the Medical Director failed to ensure the dialysis facility staff provided quality care, which resulted in egregious deficient practices, and had the potential to affect all patients the facility served (See V710), failed to ensure the dialysis facility’s social worker (SW) held a master’s degree in social work (See V713), failed to develop patient-specific orders based on standardized protocols (See V714), failed to ensure a member of the medical staff (physician, nurse practitioner, or physician assistant) and a Registered Nurse (RN) conducted initial assessments prior to the initiation of the patient’s first dialysis treatment at the facility (See V715). The cumulative effect of these systemic problems resulted in the dialysis facility’s inability to ensure the provision of safe and quality health care for the Condition of Participation §494.150: Responsibilities of the Medical Director. The findings include: A policy with revised date 5/2022, titled “Medical Director Responsibilities”, indicated the Medical Director’s responsibilities included but not limited to ensure the delivery of quality patient care and optimal clinical outcomes. On 12/14/2023 at 10:16 AM, an Immediate Jeopardy was identified under the Condition of Participation §494.80: Patient Assessment. Upon survey exit on 12/15/2023, the Immediate Jeopardy was not abated. The Medical Director failed to ensure the dialysis facility provided safe and quality health care, which resulted in non-compliance for the Condition of Participation §494.70: Patients’ Rights. The Medical Director failed to ensure the dialysis facility provided safe and quality health care, which resulted in non-compliance for the Condition of Participation §494.30: Infection control.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 42909 Based on observation, record review, and interview, the dialysis facility failed to provide a sanitary environment for 2 of 2 environmental tours of the clinic. The findings include: 1. A policy with revised date 12/15/23, titled “Cleaning and Disinfection of Equipment, Supplies, and Treatment Area”, indicated all routinely touched reusable equipment and surfaces must be disinfected after each patient’s treatment, if supplied by the center, pillows must have fluid-resistant covers which could be disinfected between each patient use, reusable supplies including but not limited to clamps must be disinfected after each patient use by soaking for a minimum of 10 minutes in the bleach solution, all surfaces of the clamps must be covered by the bleach solution, bleach solutions must be covered with a lid to prevent contamination, and splashes of blood must be cleaned up immediately. 2. The dialysis treatment room was observed on 12/12/23, beginning at 9:53 AM, and the following was observed: A. At 9:53 AM, stations #1, 16, and 17 each had clear liquid fluid draining from the acetate / acid lines onto the bottoms of the dialysis machines; there was garbage on the floor in those stations. B. At 10:22 AM, stations #16 and 17 continued to have clear liquid fluid draining from the acetate/acid lines onto the bottoms of the dialysis machines and the garbage remained on the floor in the stations. C. At 11:09 AM, Registered Nurse (RN) 1 indicated stations #1, 9, 16, and 17 were all still dirty and that the Patient Care Technicians (PCTs) were probably busy doing other things. D. At 2:25 PM, a dried red drop of fluid was observed on the seat of the dialysis chair in station #16. A clean dialyzer and other equipment for the next patient was also located on the seat. At 4:10 PM, Patient Care Technician (PCT) 1 indicated he/she didn’t know what the dried red spot was on the chair at station #16; PCT 1 removed the clean equipment/supplies and placed them on a counter marked “clean,” then disinfected the chair which removed the red spot. PCT 1 indicated the equipment/supplies were contaminated, and would be discarded. 42524 3. During an observation of the incenter on 12/11/23, observed the following, A. At 10:16 AM, observed candy, crackers, a water bottle, and an opened energy drink were observed in the drawers at the nurse’s station. During an interview on 12/11/23 at 3:07 PM, the clinical manager indicated there should not be food or drinks on the dialysis floor. B. At 10:25 AM, there were brown splashed spots in the clean sink near the lab area. C. At 11:10 AM, there was a wheelchair observed sitting in front of the fire exit. During an interview on 12/11/23 at 1:40 PM, RN 1 indicated the wheelchair should not have been placed in front of the emergency exit.”

“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: 42524 Based on observation, record review, and interview, the facility failed to ensure staff had completed appropriate hand hygiene according to hand hygiene policies and procedures in 2 of 2 staff members observed (patient care technican (PCT) 4 and registered nurse (RN) 1). The findings include: 1. The policy titled “Infection Control,” revised 11/29/2022, indicated gloves are to be worn whenever caring for a patient or touching the patient’s equipment or supplies. Hands are always washed, and gloves are removed and between patient contacts, as well as after touching blood, bodily fluid, secretions, excretions, and contaminated items. When antiseptic hand cleaners are used the product should be applied to all surfaces of the hands and fingers and rubbed vigorously until hands are dry. When soap and water are used, hands are rubbed together vigorously for at least 15 seconds. 2. During an observation on 12/11/23, the following was observed: At 1:45 PM PCT 4 donned gloves without completeing hand hygiene, then went to station 17, placed supplies on the chair side table and typed on the dialysis machine screen, opened syringes, placed them on the chair side table, typed more information into the machine, and then disconnected Patient from the machine without completing hand hygiene and don new gloves. At 10:55 AM, PCT 4 was observed at station 14 initiating dialysis with a patient with a central venous catheter (CVC). PCT 4 connected the sterile syringes and then removed their gloves. PCT 4 failed to apply the hand gel utilized to all surfaces of their hands prior to proceeding with direct patient care. At 2:05 PM, RN 1 was observed in station 11 return Patient 5’s blood at end of dialysis. RN 1 donned gloves without completing hand hygiene before they donned gloves and continued with the provision of direct patient care. 3. During an interview on 12/13/23 at 3:04 PM, the Clinical Manager indicated staff need to wash their hands when entering and exiting the floor, and in between patients, and when visibly soiled. Hand sanitizer should be used before and after donning gloves and the hand sanitizer should be used with friction until dry prior to donning gloves. 42909 4. The dialysis treatment room was observed on 12/12/23, beginning at 9:53 AM, and the following was observed: At 10:10 AM, Registered Nurse (RN) 1 performed hand hygiene using hand sanitizer, and while hands were visibly wet, RN 1 waved hands in the air, donned gloves and touched comuter screen at station 3. Then RN 1 removed gloves, applied sanitizer, waved hands, donned gloves, and went to station 7 to address an alarm. During an interview on 12/15/23 at 1:54 PM, the Medical Director indicated he didn’t know if shaking the hands while performing hand hygiene with hand sanitizer was appropriate, and indicated there was always some of that on the treatment floor. 44714 5. During an observation on 12/11/23 at 1:22 PM, registered nurse (RN) 1 removed Patient #5 from dialysis. During the process of cleaning Patient’s central venous catheter [CVC], while wearing the same gloves, RN 1 used their gloved knuckle to silence a machine alarm. After touching the machine, RN 1 returned to Patient’s CVC care without changing their gloves and completion of hand hygiene. During an interview on 12/11/23 at 1:52 PM, RN 1 indicated they used their knuckle to silence the machine since they were in the middle of CVC care and did not want to contaminate their gloves. 6.. During an observation on 12/14/2023 at 10:04 AM, patient care technician (PCT) 1 worked with Patient #8 to fix a problem which caused the dialysis machine to alarm. PCT 1 applied an insufficent amount of Purell Advanced Hand Sanitizing Gel to their hands for hand hygiene between different steps in the process. PCT 1 failed to use a sufficient amount of hand sanitizer to ensure all surfaces of their hands were wet; PCT 1 completed the hand hygiene process in 3 seconds before they applied new gloves. PCT 1 failed to complete appropriate hand hygiene 10 times while working with Patient #8. The instructions for the use of Purell Advanced Hand Sanitizer Gel (the hand sanitizer used on the treatment floor), retrieved from https:// www.gojo.com /en/Product/3659-12 indicated one needed to use enough hand gel to completely cover their hands and hands should be rubbed together until dry. The instructions indicated the process would take approximately 15 seconds. 7. During an interview on 12/14/23 at 2:35 PM, PCT 1 indicated hand hygiene required a dime - sized amount of hand sanitizer, rubbing hands until dry, then applying new gloves.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 42909 Based on observation, record review, and interview, the dialysis facility failed to ensure all non-disposable equipment was cleaned/disinfected prior to use on another patient, for 1 of 1 observation of processes and proceedures of a soiled dialysis station (#12). The findings include: A policy with revised date 11/15/23, titled “Cleaning and Disinfection of Equipment, Supplies, and Treatment Area”, indicated all routinely touched reusable equipment and surfaces must be disinfected after each patient’s treatment, if supplied by the center, pillows must have fluid-resistant covers which could be disinfected between each patient use, reusable supplies including but not limited to clamps must be disinfected after each patient use by soaking for a minimum of 10 minutes in the bleach solution, all surfaces of the clamps must be covered by the bleach solution, and bleach solutions must be covered with a lid to prevent contamination. A policy with revised date 11/29/2022, titled “Infection Control”, indicated reusable supplies would not be shared between patients without being disinfected, which included blood pressure cuffs. During observation of the facility’s treatment room on 12/12/23 beginning at 11:09 AM revealed station #9 was visibly dirty; was not yet cleaned / disinfected after the previous patient completed their treatment and left the station. Observed Registered Nurse (RN) 1 obtained the soiled blood pressure cuff from station #9 and used it on the patient in station #12. RN 1 indicated at time of observation, that station #9 was not yet cleaned, that the Patient Care Technicians (PCTs) were probably busy with other things.”

“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: 42524 Based on observation and interview the facility failed to ensure staff had completed appropriate disinfection of dialysis stations in 2 of 2 disinfection of stations observed, Patient Care Techincians (PCT’s) 2 and 4). These findings include: 1. A Review of an agency policy titled “Cleaning & Disinfection of Equipment, Supplies and Treatment Area,” revised 11/7/23, indicated all routinely touched reusable equipment and surfaces in each patient’s treatment area are disinfected after each patient’s treatment. Caregivers will ensure that cracks and crevices come in contact with the bleach solution. This includes but is not limited to the dialysis machine, chair, including the top and bottom of the chair side tables, and television. Dialysis chairs will be reclined, and all areas inspected and disinfected where blood could accumulate and not be readily noticed. If supplied by the agency pillows must have fluid resistant covers which can be disinfected between patient use. 2. During an observation on 12/11/23 at 2:00 PM, Patient Care Technician (PCT) 2 was observed cleaning station 3. PCT 2 failed to clean the top of the IV pole, failed to clean the bottom of the front of the machine, failed to clean the ledge of the machine, and failed to clean the shelf behind the dialysis station. There was an uncovered pillow on the dirty chair, PCT 2 removed the pillow cleaned the chair, and then placed the dirty pillow back on the clean chair. 3. During an observation on 12/11/23 at 2:08 PM, Patient Care Technician (PCT) 4 was observed cleaning station 8. PCT 4 failed to clean the top of the IV pole, PCT failed to clean the visible blood off the bottom corner of the machine, failed to clean the pillow that was placed on the shelf behind the station, and failed to clean the shelf. During an interview on 12/14/23 at 3:00 PM, the Clinic Manager indicated when cleaning the dialysis station everything should be cleaned with bleach cloths including the IV pole chair, all the surfaces of the machine including the top sides and back, and the shelf behind the station. 42909 4. On 12/14/23 at 10:56 AM, a container marked “1:50 bleach solution” sat on a counter marked “dirty”, and a pair of clamps stuck out above the level of the bleach solution. 44714 5. During the observation period on 12/14/23 at 10:04 AM, observed bleach water (used to disinfect the dialysis station and equipment) labeled with a concentration of 1:50. During an interview on 12/14/23 at 11:15 AM, Patient care technician (PCT) 3 indicated they prepared the bleach solution that morning at a concentration of 1:50. When asked PCT 3 was unable to state the concentration required for equipment cleaning. 6. During the observation period starting 12/14/23 at 1:53 PM, observed the label on the bleach solution was now 1:100. During an interview on 12/14/23 at 2:15 PM, PCT 1 indicated the bleach solution was 1:100 and said they changed the label. PCT 1 indicated they did not redo the bleach solution, just changed the label.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 42909 Based on observation, record review, and interview, the dialysis facility failed to ensure the staff maintained aseptic technique when handling multi-dose medication vials for 1 of 1 Patient Care Technician (PCT) observed (PCT 4). The findings include: A policy with revised date 06/2023, titled “Medications: Handling, Storage, Administration and Disposal”, indicated multi-dose medication vials must be handled aseptically (using practices and procedures to prevent contamination from potentially infectious matter). A policy with revised date 11/29/2022, titled “Infection Control, indicated all medication vial ports (septums) must be disinfected with an appropriate disinfectant prior to entry with a needle. The treatment room was observed on 12/12/2023, beginning at 9:53 AM. At 11:26 AM, a disposable barrier cloth was on top of a counter marked “clean”. Two multi-dose bottles of heparin (blood thinner), unopened and used alcohol prep pads, and sealed and empty wrappers from syringes/needles were on the barrier cloth. At 11:27 AM, PCT 4 approached the counter with gloves on, cleansed the septum of a heparin vial, and withdrew 2 separate doses of heparin without cleaning the septum between entries with a needle. During an interview on 12/12/2023 at 11:30 AM, Registered Nurse (RN) 1 indicated multi-use vials should be cleansed with alcohol prior to each use.”

“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: 42524 Based on observation, record review and interview the agency failed to ensure proper procedures were used to prevent infections in 3 of 4 observations of initiation of treatment for patients with a Central Venous Catheter (CVC) (patient care technician (PCT) 4, PCT 1 and registered nurse (RN) 1). The findings include: 1. A review of an agency policy titled “CVC Initiation & Discontinuation of Treatment,” revised 9/1/2023 indicated the hubs should be disinfected according to the manufacturer’s instructions. Allow to disinfectant to air dry. 2. During an observation on 12/11/2023 at 11:55 AM, PCT 4 was observed at station #14 initiating dialysis through a CVC at Station 14. PCT 4 removed the old dressing, removed the caps, and wiped each hub with the limb for 4 seconds failing to scrub each for at least 15 seconds. During an interview with PCT #4 at 12:15 PM, PCT 4 indicated the CVC hub should be scrubbed for a minimum of 15 seconds and air-dried before connecting the patient. During an interview on 12/13/2023 at 3:06 PM, the clinical manager indicated she couldn’t remember if there was an actual time to clean the hub. 44714 3. During an observation period beginning 1:22 PM on 12/11/2023, RN 1 disconnected Patient #4 from dialysis. RN 1 disconnected the tubing from the first CVC line, scrubbed the hub of the line and flushed saline solution into the tube. RN 1 discarded the syringes into the biohazard bin and used the computer on the dialysis machine. RN 1 returned to the patient and continued the process with the second CVC line, without changing gloves and completing hand hygiene. During an interview on 12/11/2023 at 2:35 PM, RN 1 indicated they should have completed hand hygiene and put on new gloves. 4 .During an observation period beginning at 10:04 AM on 12/14/2023, patient care technician (PCT) 1 worked with Patient #8. PCT 1 attempted to adjust tubing to stop the dialysis machine from alarming. PCT 1 removed all dialysis lines and dialyzer from the machine. PCT 1 retrieved all new equipment to restart dialysis. During the process, PCT 1 failed to clean the CVC hubs prior to attaching the tubing. During an interview on 12/14/2023 at 2:10 PM, PCT 1 a CVC hub scrub was not required when restarting dialysis.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 42524 Based on observation and interview, the dialysis facility failed evidence to maintain equipment and / or supplies in a safe manner for 2 of 2 observation periods on 12/11/23, with the potential to affect all patients. The findings include: 1. During an observation on 12/11/23, beginning at 10:16 AM, there was bottle of Liquacel (a liquid protein drink) with an open date of 8/07/23. The bottle of Liquacel indicated it was only good for 3 months once opened. 2. During the flash tour on 12/11/23, at 10:25 AM, there were 13 gold top lab tubes expired on 12/04/23 and 4 yellow tubes expired 9/03/23 observed in a cabinet in the lab area. At 10:27 AM, there were [75] seventy - five 15-gauge needles with the expiration date of 9/30/23, one gallon of bleach with an expiration date of 9/1/23, and 1800 masks with expiration date of 11/12/23. 3. During an observation in the isolation room at 2:08 PM, there was a red/black lab tube with an expiration date of 12/31/2022, a lavender top lab tube expired 11/20/2022, a 15 gauge needle expired 8/31/23 and 2 - 15 gauge needles expired 9/30/23, control solution for a glucometer (to check blood sugar) expired 5/23/23. During an interview on 12/11/23 at 3:07 PM, the Clinical Manager indicated there should not be any expired supplies. 44714 4. Beginning at 9: 30 AM, Patient care technician (PCT) 4 was observed in the laboratory station. PCT 4 removed blood - filled gold topped vials from the centrifuge (a machine that spins blood in tubes to allow for testing of the blood) and placed them in a laboratory tube holder. When requested, PCT 4 checked each gold topped tube and found an expiration date of 12/04/23. PCT 4 removed all the blood filled gold topped lab tubes for patients #13, 14, 15, 16, 17, 18, and 19. During an interview on 12/11/23 beginning at 9:30, PCT 4 indicated they were not allowed to use expired lab tubes. PCT 4 further indicated the secretary was responsible for stocking and checking for expiration dates and added there was not secretary at that time. PCT 4 did not know who was responsible for the task in the absence of the secretary. During an interview with the clinical manager on 12/11/23 at 10:30 AM, they indicated the labs would need to be redone since the tubes were expired.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 42524 Based on observations, record review and interview, the facility failed to ensure patient safety and the visualization of patient access sites were unobscured in 3 of 3 observations (Patient #12, #13, #14) The findings include: 1. During an observation on 12/11/2023 at 10:25 AM, Patient #12 station 2 had access covered with a blanket The access was still covered at 10:10 AM. The agency failed to ensure Patient access sites remain uncovered during treatment. 2. During an observation on 12/11/2023 at 10:49 AM, Patient #13 station 7 had his/her access covered with a blanket. The access was still covered at 11:20 AM. The agency failed to ensure Patient access sites remain uncovered during treatment. 3. During an observation on 12/11/2023 at 11:02 AM, Patient #14 station 5 had CVC access covered with a blanket. The access was still covered at 1:40 PM. The agency failed to ensure Patient access sites remain uncovered during treatment. During an interview on 12/12/2023 at 2:07 PM, the facility administrator indicated the Patients’ access sites should remain uncovered at all times.”

“PR-RESPECT & DIGNITY CFR(s): 494.70(a)(1) The patient has the right to- (1) Respect, dignity, and recognition of his or her individuality and personal needs, and sensitivity to his or her psychological needs and ability to cope with ESRD This Standard is not met as evidenced by: 42909 Based on observation, record review, and interview, the dialysis facility failed to ensure the patient was treated with dignity and respect, or had their personal and psychological needs met, for 1 of 1 patient observed who verbalized their needs while on the treatment floor (Patient #8). The findings include: A policy with revised date 11/30/2022, titled “Patient Rights & Responsibilities”, indicated the patient’s rights included but not limited to be treated with consideration and respect and in full recognition of the patient’s individual and personal needs. Patient #8 was observed on the treatment floor on 12/12/2023, beginning at 9:53 AM, which revealed the following: At 10:02 AM, the Patient was lying on his/her left side, with his/her head propped up with their right arm. The Patient asked for a pillow, with Patient Care Technician (PCT) 1 present. A pillow was observed on top of the Patient’s dialysis machine. At 10:19 AM, the Patient asked again for a pillow to support his/her neck. A pillow was observed on top of the Patient’s dialysis machine. Registered Nurse (RN) 1 indicated that normally, the patients bring their own pillows, the reason the patient was lying on his/her side was because the patient had a bed sore (a wound caused by unrelieved pressure), and he/she’d try to get the patient one soon. At 10:21 AM, the Patient indicated he/she was cold, and asked for a blanket. RN 1 indicated the patients were supposed to bring their own, and they (dialysis facility) didn’t have any blankets for patient use. RN 1 left the treatment area, returned with a brown coat, threw it over the patient’s legs, and walked away without speaking to the patient. At 10:50 AM, the Patient still had no pillow to support their neck. A pillow was observed on top of the Patient’s dialysis machine. At 12:07 PM, the Patient received a pillow to support their neck (2 hours and 5 minutes after the initial request was made). At 2:26 PM, the Patient complained of nausea, dizziness, felt like he/she was going to vomit, indicated his/her dialysis treatment ended at 1:30 PM, he/she was sitting in the wheelchair since that time (seated on her bottom), and indicated dialysis facility staff should have left him/her in the treatment chair until transportation arrived because he/she had a bed sore and was in terrible pain. The Patient indicated she was diabetic, and hadn’t eaten since breakfast. PCT 1 notified RN 1. RN 1 indicated that was just the Patient’s “M.O.” (modus operandi) (a term that describes an individual’s habitual pattern of operating), and failed to take any action to assist the Patient. PCT 1 informed RN 1 that the Patient’s transportation was running late, and the Patient wanted to be transferred into a treatment chair to relieve her pain. RN 1 replied to PCT 1, to ask how late, and PCT 1 replied it would be about another 20 minutes. RN 1 then replied that by the time they hoyer (mechanical lift to transfer a patient) the Patient, the transportation would probably be there, then laughed and walked away. At 2:39 PM, PCT 1 and PCT 4 transferred the Patient via hoyer lift from the wheelchair to the treatment chair. While the Patient was suspended in the sling, the Patient’s pants were exposed, and were visibly saturated from episode(s) of incontinence. During an interview on 12/12/2023 at 4:15 PM, Person 2 (staff at Entity 2, a nursing home) indicated Administrative Staff 3 (office personnel at dialysis facility) called Entity 2 at 2:17 PM, to notify Entity 2 that Patient #8 was ready to be picked up, and transportation arrived to the dialysis facility at 2:56 PM. During an interview on 12/14/2023 at 2:40 PM, the Dietician indicated that since the COVID-19 pandemic, they encouraged patients to eat before or after dialysis, and if the patient was diabetic, they would give them a protein bar during treatment. During an interview on 12/14/2023 at 2:00 PM, RN 1 indicated Patient #8 was confused sometimes, and complained that her blood sugar was low when it really wasn’t. During an interview on 12/14/2023 at 3:16 PM, the Clinical Manager indicated if the patient brought their own supplies (incontinence supplies), they could change the patient, they didn’t keep incontinence supplies on hand at the dialysis facility, and the nursing homes should send that. During an interview 12/15/2023 at 1:54 PM, the Medical Director indicated if a chair-bound patient had an incontinence episode while at the facility, they had to come off the machine and get to the bathroom, if they couldn’t get to the bathroom, the nurse or tech (PCT) would help them, and if it was a lot of stools, it would be a problem. The Medical Director indicated if a patient was cold, but didn’t have a blanket, he expect them to ask staff for one, he didn’t think they had extra blankets, and they gave patients a blanket upon admission. The Medical Director indicated they had pillows for patient use.”

“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: 42909 Based on observation, record review, and interview, the dialysis facility failed to ensure the patient’s right to privacy during verbal interactions between staff was maintained for 1 of 1 patient observed who verbalized their needs while on the treatment floor (Patient #8.) The findings include: A policy with revised date 11/30/2022, titled “Patient Rights & Responsibilities”, indicated the patient’s rights included but not limited to be treated with consideration and respect and in full recognition of the patient’s individual and personal needs, including the right for privacy in treatment, interviews, and examination to the extent possible. Patient #8 was observed on the treatment floor on 12/12/2023, beginning at 9:53 AM, which revealed the following: At 2:26 PM, the Patient complained of nausea, dizziness, felt like he/she was going to vomit, dialysis treatment ended at 1:30 PM, he/she was sitting in the wheelchair since that time (seated on her bottom), and they should have left him/her in the treatment chair until transportation arrived because he/she had a bed sore and was in terrible pain. PCT 1 verbally notified RN 1, who was located on the other side of the treatment room. RN 1 replied from the other side of the room, and indicated that was just the Patient’s “M.O.” (modus operandi) (a term that describes an individual’s habitual pattern of operating). PCT 1 informed RN 1 (from across the room) that the Patient’s transportation was running late, and the Patient wanted to be transferred into a treatment chair to relieve her pain. RN 1 replied to PCT 1, (from across the room) asked how late, PCT 1 replied (from across the room) it would be about another 20 minutes, RN 1 replied (from across the room) that by the time they hoyer (mechanical lift to transfer a patient) the Patient, the transportation would probably be there, then RN 1 laughed, turned, and walked away. Other patients were in the treatment room during this verbal interaction.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 42524 Based on observation, record review, and interview the agency failed to ensure the physician was notified of changes in conditions and failed to ensure the appropriateness of the patient’s dialysis prescriptions in 3 of 6 clinical records reviewed (Patient #1, #2, #5) The findings include: 1. A review of an agency policy titled “Charge Nurse Notification Protocol,” revised 7/8/2022, indicated the Nurse should be notified of edema swelling of face, feet, or ankles abdominal distension, shortness of breath, chest pain or discomfort, any complaints and unusual signs and symptoms. 2. A clinical record review for Patient #1, start of care 4/24/2017, included a review of the Dialysis Treatment Flowsheets, dated 8/11/2023 through 9/8/2023 and evidenced the following: On 8/14/2023, the documentation evidenced Patient #1 had shortness of breath post-treatment. The documentation failed to evidence the Physician was notified of the Patient’s shortness of breath. On 8/16/2023, 8/21/2023 8/28/2023, and 9/8/2023 the documentation evidenced Patient #1’s had lower extremity edema pre and post-treatment. The documentation failed to evidence the Physician was notified of the Patient’s edema. On 9/1/2023 the documentation evidenced Patient #1 had complaints of cramping during treatment. Documentation failed to evidence the Nurse was notified of the Patient’s cramping. During an interview on 12/13/2023 at 2:27 PM, RN 1 indicated the Physician is notified of anything that is not normal for the patient. 3. A clinical record review for Patient #2, start of care 11/11/2023, included a review of the Dialysis Treatment Flowsheets, dated 11/11/2023 through 11/16/2023 and evidenced the following: On 11/11/2023, the documentation evidenced Patient #2 had rales (abnormal breath sounds) +4 (pressure leaves an indentation of 8 mm or deeper and takes more than 20 seconds to rebound) edema (excess fluid) in the lower extremities prior to treatment. Post-treatment documentation evidenced Patient #2 had shortness of breath. The documentation failed to evidence the Physician was notified of the edema, abnormal breath sounds, and shortness of breath. On 11/14/2023, the documentation evidenced Patient #2 had edema in the lower extremities and shortness of breath. The documentation failed to evidence the Physician was notified of the edema and shortness of breath. On 11/16/2023, the documentation evidenced Patient #2’s had rales and wheezes (abnormal breath sounds) +2 edema in the lower extremities prior to treatment. Post-treatment documentation evidenced Patient #2 still had rales, wheezes, and shortness of breath. Documentation indicated Patient #2 remained in fluid overload and fluid was unable to be removed. The documentation failed to evidence the Physician was notified of the edema, abnormal breath sounds, and shortness of breath. During an interview on 12/13/2023 at 2:20 PM, RN 2 indicated the Physician was notified of Patient #4’s condition it just was not documented. 4. A clinical record review for Patient #5, start of care 8/21/2023, included a review of the Dialysis Treatment Flowsheets, dated 11/15/2023 through 12/11/2023 and evidenced the following: On 11/29/2023, the documentation evidenced Patient #2 had complaints of a headache 5/10 on the pain scale and was taken off treatment early because of the headache. The documentation failed to evidence the Physician was notified of the headache. During an interview on 12/15/2023 at 3:27 PM, the Clinical Manager indicated there should have been documentation the Physician was notified of the headache. 42909”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 42524 Based on observation, record review, and interview the dialysis facility failed to ensure patient pre/post and intradialytic blood pressure were assessed and managed for 2 of 3 (Patients # 4 and 5) incenter dialysis patients on services for more than 30 days, for 2 of 2 discharged patients who passed within the last 3 months (Patient’s 1 and 2). Findings include: 1. A policy with revised date 3/28/2023 titled “Comprehensive Patient Assessment,” indicated the patient comprehensive assessment must include at minimum the assessment criteria as defined by the by the current Conditions for Coverage. 2. A policy with revised date 9/01/2023 and titled “Patient Assessment Pre & Post Dialysis indicated the nurse responsible will be notified if the vital signs are not within normal limits. 3. Clinical record review for Patient #4 included a comprehensive assessment completed by the RN on 12/29/2022, the RD on 12/27/2022, the SW on 1/3/2023, and the physician on 10/5/2022. The assessment failed to include an evaluation of the patient’s pre/intra/post and interdialytic blood pressures, interdialytic weight gains, target weight, and related intradialytic symptoms along with an analysis for potential root causes. The review included a review of the dialysis treatment sheets from 11/15/2023 through 12/11/2023 and evidenced the following: On 11/15/2023, the documentation evidenced Patient #4’s pulse at 10:47 AM was 101, pulse at 11:32 AM was 107, pulse at 1:02 PM was 104, pulse at 1:31 was 109, pulse at 2:01 PM was 111, pulse at 2:31 PM was 110, BP at 2:49 PM, was 92/64 and pulse was 105, pulse at 2:52 PM was 103. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and pulse. On 11/17/2023, the documentation evidenced Patient #4’s, BP at 11:29 AM, was 98/58, pulse at 1:59 PM was 103, and pulse at 2:29 PM was 100. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and pulse. On 11/22/2023, the documentation evidenced Patient #4’s pulse at 1:33 PM was 101, BP at 2:31 PM, was 97/70 and pulse was 103, and BP at 2:39 PM was 86/63 and pulse was 104. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and pulse. On 11/27/2023, the documentation evidenced Patient #4’s, BP at 10:10 AM, was 179/93, and BP at 11:29 AM was 175/138. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/29/2023, the documentation evidenced Patient #4’s, BP when treatment was initiated at 10:20 AM was 213/147. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 12/4/2023, the documentation evidenced Patient #4’s, BP at 11:30 AM, was 98/65, BP at 2:00 PM was 98/64, and BP at 12:15 PM was 97/57. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 12/11/2023, the documentation evidenced Patient #4’s, BP at 2:00 PM, was 152/100, and pulse at 2:30 PM was 100. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. 4. Clinical record review for Patient #5, with first dialysis treatment at the clinic on 8/21/2023, included a comprehensive assessment completed by the RN on 11/14/2023, the RD on 11/14/2023, the SW on11/14/2023, and the physician on 11/14/2023. The assessment failed to include an evaluation of the patient’s pre/intra/post and interdialytic blood pressures, interdialytic weight gains, target weight, and related intradialytic symptoms along with an analysis for potential root causes. The review for Patient #5, start of care 8/21/2023, included a review of the Dialysis Treatment Flowsheets, dated 11/15/2023 through 12/11/2023 and evidenced the following: On 11/15/2023, the documentation evidenced Patient #5’s BP at 10:26 AM was 156/105; BP at 12:02 PM was 95/60; BP at 12:32 PM was 90/57; and BP at 1:32 PM 105/69. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/17/2023, the documentation evidenced Patient #5’s BP at 11:02 AM was 169/89 and BP at 11:33 AM was 191/97. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/20/2023, the documentation evidenced Patient #5’s pre-treatment BP was 201/95; BP at 10:26 AM was 201/95; BP at 10:28 AM was 184/85; BP at 10:59 AM was 186/99; BP at 11:29 AM was 181/96; BP at 11:59 AM was 181/95; BP at 12:29 PM, was 199/101; BP at 12:59 PM was 204/107; BP at 1:29 PM was 208/110; BP at 1:48 PM was 184/104; and BP at 1:59 PM was 206/109; and post-treatment BP was 206/109. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/22/2023, the documentation evidenced Patient #5’s pre-treatment BP was 216/102; BP at 10:07 AM was 216/102; BP at 10:18 AM was 209/99; BP at 10:29 AM was 213/110; BP at 10:59 AM was 193/107; BP at 11:29 AM was 190/102. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/24/2023, the documentation evidenced Patient #5’s pre-treatment BP was 200/105; BP at 10:32 AM was 196/97; BP at 11:51 AM was 239/114; BP at 11:59 AM was 195/99; BP at 12:50 PM was 196/102; BP at 12:59 AM was 175/86; BP at 1:32 PM, was 190/95 and post-treatment BP was 171/94. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/27/2023, the documentation evidenced Patient #5’s pre-treatment BP was 188/91; BP at 10:29 AM was 186/92; BP at 10:59 AM was 178/94; BP at 11:56 AM was 192/89; BP at 11:59 AM was 182/89; BP at 1:40 PM was 187/89; BP at 1:41 PM, was 182/102 and post-treatment BP was 182/102. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/29/2023, the documentation evidenced Patient #5’s pre-treatment BP was 191/96; BP at 10:33 AM was 182/94; BP at 11:03 AM was 171/93; BP at 12:33 PM was 176/97. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 12/1/2023, the documentation evidenced Patient #5’s BP at 11:01 AM was 187/89; BP at 11:30 AM was 192/96; BP at 12:00 PM was 199/90; BP at 12:30 AM was 189/91; BP at 1:00 PM was 192/90; BP at 1:29 PM was 206/98; BP at 1:30 PM was 205/91; BP at 2:00 PM was 212/95; 2:15 PM; 2:17 PM was 218/101 and post-treatment BP was 218/101. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 12/1/2023, the documentation evidenced Patient #5’s BP at 11:01 AM was 187/89; BP at 11:30 AM was 192/96; BP at 12:00 PM was 199/90; BP at 12:30 AM was 189/91; BP at 1:00 PM was 192/90; BP at 1:29 PM was 206/98; BP at 1:30 PM was 205/91; BP at 2:00 PM was 212/95; BP 2:17 PM was 218/101 and post-treatment BP was 218/101. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 12/4/2023, the documentation evidenced Patient #5’s pre-treatment BP was 218/97; BP at 11:01 AM was 205/122; BP at 10:03 AM was 199/102; BP at 10:33 AM was 74/92; BP at 12:03 AM was 190/96; BP at 12:34 PM was 179/96; BP at 12:34 PM was 179/92; BP at 12:42 PM was 172/95; BP at 12:50 PM, BP at 210/95; and BP at 12:51 PM was 206/97 and post-treatment BP was 206/97. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 12/6/2023, the documentation evidenced Patient #5’s pre-treatment BP was 224/82; BP at 10:20 AM was 221/99; BP at 10:34 AM was 222/107; BP at 11:03 AM was 233/114; BP at 11:33 AM was 222/113; BP at 12:03 PM was 213/112; BP at 12:38 PM was 178/99; BP at 1:03 PM, was 185/104; BP at 1:52 PM, BP at 242/220; BP at 1:53 was 107/85; and BP at 1:55 PM was 197/85 and post-treatment BP was 197/85. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 12/8/2023, the documentation evidenced Patient #5’s pre-treatment BP was 218/91; BP at 10:05 AM was 179/91; BP at 10:30 AM was 179/194; BP at 11:00 AM was 174/93; BP at 11:30 AM was 163/88; BP at 12:30 PM was165/102; BP at 1:05 PM was 181/91. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 12/11/2023, the documentation evidenced Patient #5’s pre-treatment BP was 15/130; BP at 10:20 AM was 179/128; BP at 12:33 PM was 170/99; BP at 1:03 PM was 177/92; BP at 1:28 PM was 218/101; BP at 1:33 PM was 206/99; BP at 1:38 PM was 202/96; and post-treatment BP was 202/96. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. 5. Clinical record review for Patient #1 included a comprehensive assessment completed by the RN on 7/18/2023, the RD on 7/19/2023, the SW on 7/26/2023, and the physician on 7/31/2023. The assessment failed to include an evaluation of the patient’s pre/intra/post and interdialytic blood pressures, interdialytic weight gains, target weight, and related intradialytic symptoms along with an analysis for potential root causes. A clinical record review for Patient #1, start of care 4/24/2017, included a review of the Dialysis Treatment Flowsheets, dated 8/11/2023 through 9/8/2023 and evidenced the following: On 8/11/2023, the documentation evidenced Patient #1’s BP prior to starting treatment was 159/93; at 9:59 AM, BP was 143/114 and pulse was 129. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 8/14/2023, the documentation evidenced Patient #1’s BP prior to starting treatment was 163/100; at 9:59 AM, BP was 163/100. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 8/16/2023, the documentation evidenced Patient #1’s BP at 12:02 PM was 89/62; at 12:04 PM, BP was 93/54. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 8/18/2023, the documentation evidenced Patient #1’s BP at 11:03 AM was 141/50, and at 11:32 AM, BP was 113/49. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure. On 8/21/2023, the documentation evidenced Patient #1’s pretreatment BP was 206/118; at 9:37 AM was 189/108; at 10:29 AM, BP was 174/101; at 10:49 AM, BP was 171/106; and at 10:53 AM, BP was 141/100. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 8/23/2023, the documentation evidenced Patient #1’s pretreatment BP was 197/104; at 9:11 AM was 172/102; at 11:29 AM, BP was 141/57; at 12:59 AM, BP was 90/67; and at 10:53 AM, BP was 141/100. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 8/25/2023, the documentation evidenced Patient #1’s post-treatment sitting BP was 142/82 and standing was 103/82. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure standing orders and weights. On 8/28/2023, the documentation evidenced Patient #1’s pretreatment BP was 179/107; at 10:01 AM was 148/102; at 10:59 AM, BP was 154/102; at 12:59 PM, BP was 90/67; and at 10:53 AM, BP was 141/100. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 8/30/2023, the documentation evidenced Patient #1’s BP at 9:31 AM was 154/104; at 10:29 AM, BP was 151/106; and at 11:59 AM, BP was 138/103. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 9/1/2023, the documentation evidenced Patient #1’s BP at 12:29 PM was 98/76. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure and blood pressure. On 9/4/2023, the documentation evidenced Patient #1’s pre-treatment BP was 166/122; BP at 8:57 AM was 175/149; at 8:59 AM, BP was 163/102; at 9:29 AM, BP was 164/101; BP at 9:59 AM was 162/121; BP at 11:59 AM was 168/108; post-treatment standing BP was 182/99 and standing was 145/96. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 9/8/2023, the documentation evidenced Patient #1’s pre-treatment BP was 189/107; BP at 9:09 AM was 170/99; BP at 9:29 AM was 155/109; BP at 10:59 AM was 206/90; BP at 12:59 PM was 160/103; post-treatment sitting BP was 147/85 and standing was 170/100. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. 6. Clinical record review for Patient #2 evidenced 11/11/2023 was Patients first hemodialysis treatment within the clinic and was deceased on 11/18/2023. The included a comprehensive assessment completed by the RN on 11/30/2023, the RD on 11/30/2023, the SW on11/30/2023, and the physician on 11/30/2023. The assessment failed to include an evaluation of the patient’s pre/intra/post and interdialytic blood pressures, interdialytic weight gains, target weight, and related intradialytic symptoms along with an analysis for potential root causes. A clinical record review for Patient #2, start of care 11/11/2023, included a review of the Dialysis Treatment Flowsheets, dated 11/11/2023 through 11/16/2023 and evidenced the folloowing. On 11/11/2023, the documentation evidenced Patient #2’s pre-treatment BP was 110/58: BP at 11:57 AM was 110/55; at 12:29 PM, BP was 102/56; at 12:59 PM, BP was 92/47; at 1:00 PM, BP was 87/59; at 1:04 PM, BP was 86/57; at 1:30 PM, BP was 81/52; at 1:49 PM, BP was 102/53; at 1:59 PM, BP was 86/51; 2:29 PM, BP was 96/54 and at 2:31 PM, BP was 104/53. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/14/2023, the documentation evidenced Patient #2’s pre-treatment BP was 89/52: BP at 11:05 AM, was 56/40; at 11:07 AM, BP was 47/29; at 11:09 AM, BP was 70/39; at 11:10 AM, BP was 70/29; at 11:12 AM, BP was 78/43; at 11:15 AM, BP was 74/26; at 11:17 AM, BP was 107/38; at 11:32 AM, BP was 40/23; at 12:02 PM, BP was 73/44; at 12:31 PM, BP was 89/47; at 1:32 PM, BP was 98/40; at 2:02 PM, BP was 91/48; at 2:31 PM, BP was 87/58; at 1:59 PM, BP was 86/51; 2:29 PM, BP was 96/54. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. On 11/16/2023, the documentation evidenced Patient #2’s pre-treatment BP was 85/45; at 11:07 AM, BP was 90/43; at 11:20 AM, BP was 91/38; at 11:32 AM, BP was 88/41; at 11:47 AM, BP was 69/49; at 12:01 PM, BP was 66/60; at 12:10 PM, BP was 94/50; at 12:17 PM, BP was 92/52; at 12:31 PM, BP was 93/45; at 12:47 PM, BP was 99/89; at 1:02 PM, BP was 74/36; at 1:31 PM, BP was 88/44; at 2:19 PM, BP was 82/60; at 2:40 PM, BP was 87/49; 2:42 PM, BP was 75/57; and post-treatment BP was 91/52. The record failed to evidence the clinical staff implemented the policy and procedures for the treatment of blood pressure. 42909 44714”

“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: 42524 Based on record review and interview, the facility failed to ensure patients’ volume status was maintained by being within 1 kilogram (kg) of their expected dry weight post-treatment and failed to notify the physician when post-treatment weight was greater than/less than 1 kilogram of the ordered dry weight for 4 of 6 in-center hemodialysis records reviewed (#1, #4, #5, #8) and failed to ensure patient blood pressures were monitored per policy in 1 of 6 in-center hemodialysis patients clinical records reviewed. (Patient #1) The findings include: 1. An agency policy titled “Monitoring and Documentation of Patient Care During Treatment,” revised 11/29/2022, indicated data such as blood pressure and heart rates must be documented every 30 minutes and PRN depending on the patient’s condition. 2. An agency policy titled “Charge Nurse Notification Protocol,” revised 7/8/2022, indicated the nurse should be notified of a weight over or under 1 kg of the patient’s dry weight. 3. An agency policy revised 3/28/2023 titled “Comprehensive Patient Assessment,” indicated the patient comprehensive assessment must include at minimum the assessment criteria as defined by the by the current Conditions for Coverage. 4. Clinical record review for Patient #1 included a comprehensive assessment completed by the RN on 7/18/2023, the RD on 7/19/2023, the SW on 7/26/2023, and the physician on 7/31/2023. The assessment failed to include an evaluation of the patient’s pre/intra/post and interdialytic blood pressures, interdialytic weight gains, target weight, and related intradialytic symptoms along with an analysis for potential root causes. The record review for Patient #1, start of care 4/24/2017, included a review of the Dialysis Treatment Flowsheets, dated 8/11/2023 through 9/8/2023 and evidenced the following: On 8/14/2023, the documentation evidenced Patient #1’s estimated dry weight (EDW) was 123 kilograms (kg), pre-weight was 128.5 kg and post-weight was 124.5 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. On 8/16/2023, the documentation evidenced Patient #1’s EDW was 123 kilograms kg, pre-weight was 129.8 kg, and post-weight was 125.4 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. On 8/18/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 128.7 kg, and post-weight was 125.6 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. On 8/21/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 131.3 kg, and post-weight was 127.3 kg. Documentation evidenced Patient #1’s BP was monitored at 9:37 AM and not again until 10:29 AM, and BP was monitored at 12:59 PM and not again until 1:42 PM. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight and failed to evidence blood pressure was monitored every 30 minutes per policy. On 8/23/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 129 kg, and post-weight was 126.1 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. On 8/25/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 128.5 kg, and post-weight was 124.9 kg. Documentation evidenced Patient #1’s BP was monitored at 9:06 AM and not again until 10:06 AM This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight and failed to evidence blood pressure was monitored every 30 minutes per policy. On 8/28/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 130.3 kg, and post-weight was 125.7 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. On 8/30/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 129.5 kg, and post-weight was 125.3 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. On 9/1/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 129.3 kg, and post-weight was 125.3 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. On 9/4/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 130.3 kg, and post-weight was 126.1 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. On 9/8/2023, the documentation evidenced Patient #1’s EDW was 123 kg, pre-weight was 131.3 kg, and post-weight was 126.1 kg. This document failed to evidence the Physician was notified Patient #1 failed to meet the target weight. 5. Clinical record review for Patient #4 included a comprehensive assessment completed by the RN on 12/29/2022, the RD on 12/27/2023, the SW on 1/3/2023, and the physician on 10/5/2022. The assessment failed to include an evaluation of the patient’s pre/intra/post and interdialytic blood pressures, interdialytic weight gains, target weight, and related intradialytic symptoms along with an analysis for potential root causes. The clinical record review for Patient #4, start of care 9/5/2022, included a review of the dialysis treatment sheets from 11/15/2023 through 12/11/2023 and evidenced the following: On 11/15/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 100.8 kg, and post-weight was 98.2 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/17/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 98.7 kg, and post-weight was 94.2 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/20/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 97.7 kg, and post-weight was 95.5 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/22/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 97 kg, and post-weight was 94.2 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/24/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 97 kg, and post-weight was 94.9 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/27/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 99.8 kg, and post-weight was 96.9 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/29/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 100.5 kg, and post-weight was 97.2 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/1/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 100.3 kg, and post-weight was 97.5 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/4/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 101.6 kg, and post-weight was 100.5 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/6/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 103.6 kg, and post-weight was 100.3 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/8/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 102.4 kg, and post-weight was 100.4 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/11/2023, the documentation evidenced Patient #4’s EDW was 90 kilograms kg, pre-weight was 102.6 kg, and post-weight was 99.2 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. 6. Clinical record review for Patient #5 included a comprehensive assessment completed by the RN on 11/14/2023, the RD on 11/14/2023, the SW on11/14/2023, and the physician on 11/14/2023. The assessment failed to include an evaluation of the patient’s pre/intra/post and interdialytic blood pressures, interdialytic weight gains, target weight, and related intradialytic symptoms along with an analysis for potential root causes. The record review for Patient #5, start of care 8/21/2023, included a review of the Dialysis Treatment Flowsheets, dated 11/15/2023 through 12/11/2023 and evidenced the following: On 11/22/2023, the documentation evidenced Patient #5’s EDW was 38 kilograms kg, pre-weight was 41.8 kg, and post-weight was 40 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/24/2023, the documentation evidenced Patient #5’s EDW was 38 kilograms kg, pre-weight was 42.3 kg, and post-weight was 39.2 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/27/2023, the documentation evidenced Patient #5’s EDW was 38 kilograms kg, pre-weight was 41.6 kg, and post-weight was 39.7 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 11/29/2023, the documentation evidenced Patient #5’s EDW was 38 kilograms kg, pre-weight was 42.6 kg, and post-weight was 40.8 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/1/2023, the documentation evidenced Patient #5’s EDW was 38 kilograms kg, pre-weight was 43.6 kg, and post-weight was 37.9 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/4/2023, the documentation evidenced Patient #5’s EDW was 38 kilograms kg, pre-weight was 43.6 kg, and post-weight was 42 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/6/2023, the documentation evidenced Patient #5’s EDW was 38 kilograms kg, pre-weight was 45, and post-weight was 42 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. On 12/8/2023, the documentation evidenced Patient #5’s EDW was 38 kilograms kg, pre-weight was 42.9 and post-weight was 39.9 kg. This document failed to evidence the Physician was notified Patient #4 failed to meet the target weight. 42909 7. The clinical record for Patient #8 included a Dialysis Order Report (initial treatment order) dated 11/28/2023, which failed to evidence the patient’s dry weight. A dialysis treatment sheet dated 12/02/2023 evidenced pre-dialysis weight of 65.8 kg (145.06 lb), post-dialysis weight of 59.1 kg (130.29 lb), and the target dry weight was “TBD” (to be determined.) A dialysis practitioner visit note dated 12/05/2023 indicated the target dry weight was “TBD”. A dialysis treatment sheet dated 12/05/2023 indicated pre-dialysis weight of 59.7 kg (131.62 lb), post-dialysis weight of 60.9 kg (134.26 lb), and the target dry weight was “TBD”. A dialysis treatment sheet dated 12/07/2023 indicated pre-dialysis weight of 40.3 kg (88.85 lb), post-dialysis weight of 40.0 kg (88.18 lb), and the target dry weight was “TBD”. A dialysis practitioner visit note dated 12/07/2023 indicated the target dry weight was “TBD”. A dialysis treatment sheet dated 12/09/2023 indicated pre-dialysis weight of 59.2 kg (130.51 lb), post-dialysis weight of 40.8 kg (89.99 lb), and the target dry weight was “TBD”. A dialysis treatment sheet dated 12/12/2023 indicated pre-dialysis weight of 42.0 kg (92.6 lb), post-dialysis weight of 42.5 kg (93.7 lb), and the target dry weight was “TBD”. A dialysis practitioner visit note dated 12/12/2023 indicated the target dry weight was “TBD”. A Dietician Monthly Review note dated 12/12/2023 indicated there was a large discrepancy in weight since patient started dialysis, and the patient’s usual body weight was around 140.0 lb. During an interview on 12/14/2023 at 10:21 AM, the Clinical Manager indicated the initial plan of care/comprehensive assessment was due by 30 days of initial treatment or within 13 dialysis treatments, whichever was sooner, and they could be done sooner than that if needed. During an interview on 12/14/2023 at 1:56 PM, RN 1 indicated Patient #8’s first dialysis treatment occurred on 12/02/2023, the initial plan of care/comprehensive assessment wasn’t completed because it wasn’t due yet, Entity 2 (skilled nursing facility) put the weight in as pounds for the wheelchair, they just caught the error this Tuesday (12/12/2023), and the weight of the wheelchair caused the discrepancies in the weights. When asked if the patient’s target dry weight was established, RN 1 questioned him/herself if the patient’s target dry weight was determined yet, then indicated he/she could “fix that now”, because she worked a long time with the Medical Director here as well as other facilities. During an interview on 12/14/2023 at 2:40 PM, the Dietician indicated they just found out today that the weights were wrong because of the wheelchair, and he/she spoke to the patient’s family, who indicated the patient’s usual weight was more in line at 133 lb. During an interview on 12/15/2023 at 1:54 PM, the Medical Director indicated the initial target dry weight was determined by the physician within the first few treatments.”

“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: 42524 Based on observation, record review, and interview, the facility failed to ensure patient dialysis prescription orders were verified and adhered to in order to achieve and sustain the prescribed dose of dialysis to meet the adequacy of dialysis in 2 out of 6 in center hemodialysis records reviewed (Patient #2 and #4) and 1 of 1 observation on the dialysis floor (Patient #9). The findings include: 1. An agency policy titled “Monitoring and documentation of Patient Care During Treatment,” revised 11/29/2022 indicated data that must be documented by direct data entry and/or by data feed from the dialysis machine every 30 minutes and PRN depending on the patient’s condition includes, but not limited to: blood flow rate (BFR) dialysate flow rate (DFR), and if the patient’s prescription was not met for any reason a detailed progress note must be entered explaining why the prescription was not met and what actions were taken to address the situation. 2. A clinical record review for Patient #2, start of care 11/11/2023, included a review of the dialysis treatment sheets from 11/11/2023 through 11/16/2023 and evidenced the following: The flowsheet dated 11/11/2023 documented Patient #2’s prescribed treatment time was 3 hours and 30 minutes. Documentation evidenced Patient #2 received 2 hours and 30 minutes of treatment. The documentation failed to evidence the Physician was notified Patient #2 did not receive the full prescribed treatment time. The flowsheet dated 11/16/2023 documented Patient #2’s prescribed blood flow rate (BFR) was 400 ml/min (milliliter/minute) During treatment Patient #2’s BFR was 300 ml/min. The review failed to evidence why Patient #2 did not receive the prescribed blood flow rate. 3. A clinical record review for Patient #4, start of care 9/5/2022, included a review of the dialysis treatment sheets from 11/15/2023 through 12/11/2023 and evidenced the following: The flowsheet dated 11/22/2023 documented Patient #4’s prescribed BFR was 400 ml/min. During treatment, Patient #4’s BFR was 300 ml/min. The review failed to evidence why Patient #4 did not receive the prescribed blood flow rate. The flowsheet dated 11/24/2023 and 11/29/2023 documented Patient #4’s prescribed BFR was 400 ml/min. During treatment, Patient #4’s BFR was 350 ml/min. The review failed to evidence why Patient #4 did not receive the prescribed blood flow rate. The flowsheet dated 12/1/2023 documented Patient #4’s prescribed BFR was 400 ml/min. During treatment, Patient #4’s BFR was 200 ml/min. The review failed to evidence why Patient #4 did not receive the prescribed blood flow rate. The flowsheet dated 12/1/2023 documented Patient #4’s prescribed treatment time was 4 hours. Documentation evidenced Patient #4 received 3 hours and 28 minutes of treatment. The documentation failed to evidence the Physician was notified Patient #4 did not receive the full prescribed treatment time. The flowsheet dated 12/6/2023 documented Patient #4’s prescribed treatment time was 4 hours. Documentation evidenced Patient #4 received 3.5 hours of treatment. The documentation failed to evidence the Physician was notified Patient #4 did not receive the full prescribed treatment time. 4. A clinical record review for Patient #5, start of care 8/21/2023, included a review of the Dialysis Treatment Flowsheets, dated 11/15/2023 through 12/11/2023 and evidenced the following: The flowsheets dated 11/27/23. 11/29/23, and 12/8/2023 documented Patient #5s prescribed treatment time was 3.5 hours. Documentation evidenced Patient #5 received 3 hours of treatment. The documentation failed to evidence the Physician was notified Patient #5 did not receive the full prescribed treatment time. 42909 5. An observation of the treatment floor on 12/12/2023 at 10:54 AM revealed RN 1 moved Patient 9’s chair at station 11, the the dialysis machine shut down completely, and the screen went black. RN 1 discovered the power cord was dislodged from the electric outlet behind the patient’s chair. RN 1 plugged the machine in, and failed to check the settings/dialysis prescription prior to leaving the station. During an interview on 12/12/2023 at 11:00 AM, RN 1 indicated the settings should all be correct after the machine was plugged back in, and it didn’t need to be checked again.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 42524 A review of employee files on 12/15/2023 evidenced the Social Worker (SW) was hired on 1/3/2021. Documentation evidenced the SW had an active Bachelor Social Worker license and a temp Social Worker license. A review of the SW employee file failed to evidence an M degree was obtained in Social work. The record review failed to evidence the agency had a SW with a Master’s degree employed at the agency. During an interview on 12/15/2023, the Clinical Manager indicated the Social worker split therir time between two locations and indicated the Social worker’s Master’s license was pending, as she just obtained her Master’s degree. 42909 Based on record review and interview, the Medical Director failed to ensure the dialysis facility’s social worker (SW) held a master’s degree in social work, for 1 of 1 SW personnel record reviewed (SW 1). The findings include: A policy with revised date 5/2022, titled “Medical Director Responsibilities”, indicated the Medical Director’s responsibilities included but not limited to ensuring staff had appropriate education and training. A policy with revised date 9/01/2023, titled “Staffing: Medical & Clinical”, indicated the facility must have a social worker who holds a master’s degree in social work with a specialization in clinical practice from a school of social work accredited by the Counsel on Social Work Education, and a licensed clinical social worker (LCSW) was preferred. During an interview on 12/15/2023 at 1:54 PM, the Medical Director indicated he didn’t think he’d ever seen a non- LCSW in the dialysis setting.”

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 42909 Based on record review and interview, the Medical Director failed to ensure the clinic developed patient-specific orders based on standardized protocols which had the potential to affect all facility patients. The findings include: A policy with revised date 11/15/2023 and titled “Orders for Patient Care,” indicated orders based on protocols may not serve as an order by iteself; when a protocol-driven medical intervention is implemented, a complete patient-specific order must be entered into the patient’s medical record and signed by the physician. A policy with revised date 5/2022, titled “Protocols,” indicated interventions based on protocols must have an accompanying patient-specific valid physician order for each intervention provided that is based on the protocol. During an interview on 12/15/2023 at 1:54 PM, the Medical Director indicated standing orders (protocols) were created by their corporate and were the same across the board at all corporate facilities. During an interview on 12/15/2023 at 3:04 PM, the Clinical Manager indicated standing orders were the same for all patients, she just printed a random patient sample for review and indicated there was no need to print each patient’s protocol since they were all the same.”

“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: 42909 Based on record review and interview, the Medical Director failed to ensure neither a member of the medical staff nor a Registered Nurse (RN) conducted an initial assessment prior to the initiation of the patient’s first dialysis treatment at the facility for 1 of 1 patient admitted for dialysis treatments in December of 2023 (Patient #8). The findings include: A policy with revised date 3/28/2023, titled “Comprehensive Patient Assessments”, indicated an initial assessment must be conducted by a member of the medical staff (i.e., physician, advanced practice RN [APRN], or physician’s assistant [PA]) before the initiation of the patient’s first dialysis treatment at the facility, in order to develop the admission treatment orders and to promptly identify and address urgent patient medical needs, prior to completion of the comprehensive patient assessment. The policy also indicated the assessment could be accomplished by a review of medical records and consultation with the referring physician. Documentation of the assessment could be done by a progress note in the patient’s medical record, or provision of the patient’s current medical records (such as a history and physical) that was signed and dated by the patient’s nephrologist. A policy with revised date 9/01/2023, titled “Patient Assessment: Pre & Post Dialysis”, indicated if the patient was a new admission and was not previously treated at the facility prior, a RN must perform and document the full pre-dialysis assessment before the initiation of or at the beginning of the first treatment at the center to identify and address any problems that may prohibit or complicate the dialysis treatment, and assessment would include review of medications. The clinical record for Patient #8 evidenced hospital documentation dated 11/11/2023 that included, but was not limited to, patient history, medications, diagnoses, and hospitalization dates. The document was not co-signed nor dated by the Medical Director (Patient’s Nephrologist) or Nurse Practitioner (NP) 1, to confirm a review and assessment was completed prior to the first dialysis treatment. A “Dialysis Order Report” evidenced the initial treatment order was generated on 11/28/2023 by the Clinical Manager, and NP 1 approved and electronically signed the initial treatment order on 12/07/2023 (5 days after the first dialysis treatment.) The admission and first dialysis treatment occurred on 12/02/2023, from 9:51 AM - 1:23 PM. The “Nursing Initial Assessment” indicated the assessment was saved, approved, and signed by the Clinical Manager on 12/03/2023 at 8:36 PM (1 day after the first dialysis treatment), and failed to evidence the patient’s medications were reviewed. A “Dialysis Visit Note” (practitioner/physician visit note) dated 12/05/2023 (3 days after the first dialysis treatment) evidenced no hospital records were found for review, no home medication records were found for review, and no labs were reviewed. During an interview on 12/14/2023, RN 1 indicated she did not perform Patient #8’s “Nursing Initial Assessment” dated 12/02/2023. During an interview on 12/14/2023, RN 1 indicated she did not perform Patient #8’s initial nursing assessment. During an interview on 12/14/2023 at 2:56 PM, the Clinical Manager indicated she did not perform Patient #8’s Nursing Initial Assessment that RN 1 did and was the assessment they did prior to initiation of dialysis treatments, she only approved the assessment, she didn’t know why the computer software “did it like that,” and didn’t know why there was no electronic signature for the nurse who actually completed the assessment. During an interview on 12/15/2023 at 1:54 PM, the Medical Director indicated when a referral was received, and documentation was sent from the hospital, relayed the Clinical Manager looked at all of that information, gave him a summary, and sometimes the social worker would look at the information from the hospital. The Medical Director indicated the NP or Medical Director was responsible to create the treatment orders and to determine the dialysis prescription.”