Midtown Home Dialysis LLC

“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: 34696 Based on observatiion, record review, and interview, the dialysis facility failed to develop and maintain an emergency preparedness program that provided a 1) safe evacuation plan for all patientts, and 2) orientation and training for three of three patients (Patients #2, #3, and #4). Findings included: 1) The facility failed to develop and implement a plan for safe evacuation of all patients on census at the facility in the event of an emergency i.e., fire, tornado, and power outage. Cross refer to EP 0020. 2) The dialysis facility failed to provide three of three patients (Patients #2, #3, and #4) emergency preparedness orientation and training. Cross refer to EP 0040.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 34696 Based on record review and interview, the IDT (Interdisciplinary Team) failed to ensure two of six patients (Patients #7 and #8) had medical oversight and/or was seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant for eight months in 2024. Findings included: The IDT failed to ensure two of six patients (Patients #7 and #8) had medical oversight and/or was seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant . Cross refer to V 560.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 34696 Based on record review, and interview, the medical director did not demonstrate responsibility to ensure 1) all patients had emergency preparedness education and training, 2) all patients had medical oversight, 3) home therapy records were retrieved and reviewed, and 4) monthly QAPI (Quality Improvement and Performance Improvement) meetings were conducted. Findings included: 1) The dialysis facility failed to develop and maintain an emergency preparedness program that provided a 1) safe evacuation plan for all patients, and 2) orientation and training for three of three patients (Patients #2, #3, and #4). Cross refer to EP 0003. 2) The IDT (Interdisciplinary Team) failed to ensure two of six patients (Patients #7 and #8) had medical oversight and/or was seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant for eight months in 2024. Cross refer to V 540. 3) The IDT failed to retrieve and review the treatment records for one of two PD (Peritoneal Dialysis) patients (Patient #5) since admission in 12/2022. Cross refer to V 580. 4) The facility failed ensure the QAPI committee conducted monthly QAPI meetings from 01/2024 to 10/2025. Cross refer to V 625.”

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 34696 Based on observation, record review, and interview, the facility failed to develop and implement a plan for safe evacuation of all patients on census at the facility in the event of an emergency i.e., fire, tornado, and power outage. Findings included: A review of the “Emergency Management - Patient Education” policy revision date 10/01/2024 included, “Upon admission to...Dialysis, patients...shall recieve instructions in case of an emergency disaste...How to disconnect themselves from the dialysis machine if an emergency occurs...How they would be evacuated from the facility...All patient education addressing emergency management and emergency evacuation shall be docuented in the patient’s medical record.” On 01/21/2025 at 2:25 PM, it was observed that the dialysis facility was located on the third floor of the building. On 01/21/2025 at 4:00 PM, during a tour of the facility, it was observed that a large hemodialysis treatment chair sat in a room with hemodialysis machines that were stored in the room. The COO (Chief Operations Officer, Personnel #1) said Patient #4 was a bariatric patient who dialyzed in the room. Personnel #1 said the hemodialysis treatment chair for Patient #4 had to be constructed inside the room because the chair could not fit through the entrance of the room. Patient #4’s hemodialysis treatment record dated 01/24/2025 indicated that the EDW (estimated dry weight) was 260 Kgs. (kilograms)- 572 lbs. (pounds). The pre-treatment weight on that date was 283 Kgs. - 622 lbs. On 01/29/2025 at 1:15 PM, Patient #4 was observed dialyzing in the room. Patient #4 said he was not ambulatory, but he could stand and pivot. Patient #4 was asked if he had been educated on emergency procedures related to removing himself from the hemodialysis machine. He said, “No.” On 01/29/2025 at 1:20 PM, during an interview, the RN (Registered Nurse Educator, Personal #2) was asked if Patient #4 had been educated regarding the facility’s emergency procedures for evacuation. He said, “No.” On 01/29/2025 at 1:45 PM, interviews were conducted with the RN (Personnel #4) and the CCHT (Certified Clinical Hemodialysis Technician, Personnel #5). During the interviews, the RN and CCHT were asked if there was an emergency that required evacuation, would they be able to assist Patient #4 in getting out of the building from the third floor. They both said, no. The patient would be too heavy to move. On 01/30/2025 at 11:30 AM, during the facility’s exit conference, the CEO (Chief Executive Officer, Personnel #3) and the COO said there was no emergency plan developed for Patient #4’s safe evacuation.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 34696 Based on observation, record review, and interview, the dialysis facility failed to provide three of three patients (Patients #1, #2, #3, and #4) emergency preparedness orientation and training. Findings included: A review of the “Emergency Management - Patient Education” policy revision date 10/01/2024 included, “Upon admission to...Dialysis, patients...shall receive instructions in case of an emergency disaster...How to disconnect themselves from the dialysis machine if an emergency occurs...How they would be evacuated from the facility...All patient education addressing emergency management and emergency evacuation shall be docuented in the patient’s medical record.” On 01/21/2025 at 2:25 PM, it was observed that the dialysis facility was located on the third floor of the building. On 01/22/2025 at 10:10 AM, the surveyor interviewed Patient #2 while on treatment. Patient #2 was asked if they had been educated on emergency procedures related to removing herself from the hemodialysis machine in the event of a fire, tornado, or a power outage. They said “No.” On 01/22/2025 at 10:55 AM, the surveyor interviewed Patient #3 while on treatment. Patient #3 was asked if they had been educated on emergency procedures related to removing himself from the hemodialysis machine in the event of a fire, tornado, or a power outage. They said “No.” On 01/29/2025 at 1:15 PM, Patient #4 was observed dialyzing in the room. Patient #4 said he was not ambulatory, but he could stand and pivot. Patient #4 was asked if he had been educated on emergency procedures related to removing himself from the hemodialysis machine. He said, “No.” On 01/29/2025 at 1:20 PM, during an interview, the RN (Registered Nurse Educator, Personal #2) was asked if Patient #4 had been educated regarding the facility’s emergency procedures for evacuation. He said, “No.” On 01/29/2025 at 1:35 PM, the COO (Chief Operations Officer, Personnel #1) said Patients #1, #2, #3, and #4 did not have emergency preparedness orientation and training.”

“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: 34696 Based on observation, record review, and interview, the facility failed to ensure two of two DPC (direct patient care) staff (Personnel #4 and #5) removed gloves their and washed or washed their hands after providing patient care. Findings included: A review of the “Infection Prevention and Control Practices” policy revised 10/01/2024 included, “Hand hygiene shall be followed by all staff...hands always shall be washed after gloves are removed and between patient contacts...and contaminated items.” On 01/22/2025 during observation of care in the hemodialysis treatment area, the following was observed: ~ At 10:40 AM, it was observed that the CCHT (Certified Clinical Hemodialysis Technician, Personnel #5) put on gloves to raise the foot rest on the chair of Patient #3. The CCHT removed their gloves and did not wash their hands. At the time of the findings, the surveyor asked the CCHT if they were supposed to sanitize their hands after removing their gloves. They said, “yes.” ~ At 10:45 AM, the RN (Registered Nurse, Personnel #4) was observed providing care to Patient #3. The RN removed their gloves and did not wash their hands. At the time of the findings, the surveyor asked the RN why they did not wash their hands. The RN used contaminated hands to retrieve an alcohol pad to clean their stethoscope. The RN stated, “I’m going to do this first.””

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 34696 Based on record review and interview, the IDT (Interdisciplinary Team) failed to develop one of four patient’s (Patient #1) unstable Plan of Care (POC). Findings included: A review of the “Patient Plan of Care” policy revision date 10/01/2024 indicated, “A written individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition...The plan of care shall be completed by the interdisciplinary team, including the patient...implementation of monthly...updates of the plan of care shall be performed within 15 days of the completion of the additional patient assessments.” ~ Patient #1: The Clinical Record indicated Patient #1 was deemed unstable in May 2024. There was no documented evidence that the IDT developed Patient #1’s monthly unstable/stable POC In an interview on 01/29/2025 at 9:45 AM, the COO (Chief Operations Officer,Personnel #1) said there was no documented evidence of a monthly unstable/stable POC.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 34696 Based on record review and interview, the IDT (Interdisciplinary Team) failed to ensure two of six patients (Patients #7 and #8) had medical oversight and/or was seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant . Findings included: ~ Patient #7: The Clinical Record indicated Patient #7 was admitted to the facility in 12/2023. The Clinical Record did not include documented evidience that Patient #7 had medical oversight and/or was seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant for eight monts in 2024 (April, May, June, July, August, October, November, and December). ~ Patient #8: The Clinical Record indicated Patient #8 was admitted to the facility in 12/2023. The Clinical Record did not include documented evidience that Patient #8 had medical oversight and/or was seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant for eight monts in 2024 (April, May, June, July, August, October, November, and December). On 01/30/2025 at 11:00 AM, the RN (Registered Nurse, Personnel #4) said there was no documented evidence of medical oversight for Patients #7 and #8 for eight months in 2024.”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 34696 Based on record review and interview, the IDT (Interdisciplinary Team) failed to retrieve and review complete treatment records at least every two months for one of two PD (Peritoneal Dialysis) patient (Patient #5) and maintain this information in the patient’s medical record. Findings included: ~ Patient #5: The Clinical Record indicated Patient #5 was admitted to the facility in 12/2022. There was no documented evidence of Patient #5’s PD treatment records. On 01/30/2025 at 10:40 AM, the RN (Registered Nurse, Personnel #4) said there was no documented evidence of Patient #5’s PD treatment records. The RN said she did not have documented evidence of education provided to the patient regarding submission of the treatment records.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 34696 Based on record review and interview, the facility’s QAPI (Quality Assessment and Performance Improvement) committee failed to track, measure, and analyze the facility’s quality indicators or other aspects of performance that reflect the processes of care and facility operations, monthly from 01/2024 through 01/2025. Findings included: On 01/22/2025 at 11:00 AM in an interview, the COO (Chief Operations Officer, Personnel #1) said there was no documented evidence of the facility’s QAPI meetings or meeting minutes. The COO said the facility had not conducted QAPI meetings since before he took over as COO, eight months ago.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 34696 Based on record review and interview, the IDT (Interdisciplinary Team) failed to maintain complete and accessible records on one of one patient (Patient #2). Findings included: A review of the “Verbal and Written Orders - General” policy revision date 10/01/2024 included,”All orders of medication and treatment shall be written into the medical record of the patient and signed by the ordering licensed practitioner...verbal and telephone orders of medication shall be received and recorded by the...licensed nurse...record the verbal/telephone order immediately in the patient’s medical record.” ~ Patient #2: The Clinical Record indicated that Patient #2 had a low hemoglobin result of 6.7 on 10/07/2024. A nurse’s progress note dated 10/07/2024 included, “Patient arrived...complaining of shortness of breath.” A nurse’s progress note dated 10/08/2024 included, “Urgent Lab Report...Spectra called to report Hemoglobin of 6.7 for patient...Clinic staff notified and verbalized understanding.” There was no documented evidence in the Clinical Record that the nurse notified the physician of Patient #2’s low hemoglobin. On 01/29/2025 at 10:50 AM, the COO (Chief Operations Officer, Personnel #1) said there was texting between the nurse and the physician, but no documented evidence in Patient #2’s Clinical Record to be shared with other members of the IDT. The COO said that a verbal order should be recorded immediately in the patient’s medical record.”