New Start Dialysis Center LLC

“Fire Alarm System - Testing and Maintenance CFR(s): NFPA 101 Fire Alarm Systems - Testing and Maintenance A fire alarm system is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code. Records of system acceptance, maintenance and testing are readily available. 9.6.1.3, 9.6.1.5, NFPA 70, NFPA 72 This Standard is not met as evidenced by: 30369 Based on records review and staff interview, it was determined that the facility failed to perform fire alarm testing and maintenance in accordance with NFPA 101. Findings include: During the records review process of the facility between 10:00 am and 4:00 pm on 05/22/2025 with the Administrator, it was revealed that there was no documentation for the performance of fire alarm 1 of 1 duct detector pressure differential test within the last 12 months. During the Staff Interview between 10:00 am and 4:00 pm on 05/22/2025, the Administrator acknowledged this finding. NFPA 101 (2012 Edition) 21.3.4.1, 9.6 NFPA 72 (2010 Edition) Chapter 14 Table 14.4.2.2”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 30369 Based on records review and staff interview, it was determined that the facility failed to perform fire sprinkler system testing and maintenance in accordance with NFPA 101. Findings include: During the records review process of the facility between 10:00 am and 4:00 pm on 05/22/2025 with the Administrator, it was revealed that there was no documentation for the performance of fire sprinkler system testing in a timely manner. The reports dated 02/28/2025 (Quarterly) and 12/12/2024 (Quarterly) were provided during survey. During the Staff Interview between 10:00 am and 4:00 pm on 05/22/2025, the Administrator acknowledged this finding. NFPA 101 (2012 Edition) 21.7.6, 4.6.12 NFPA 25 (2011 Edition) Chapter 5, Table 5.1.1.2”

“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: 40153 Based on observation, interviews and chart review, the facility staff failed to ensure proper hand hygiene for 3 of 3 Patients observed before and after dialysis treatments (Patient #6, Patient #7 and Patient #9). Findings include: A review of the facility’s poster not dated showed the following: Please wash your hands before your treatment and after treatment. 1. In an observation conducted on 05/21/25 at 9:09 AM, Patient #6 was done with his Hemodialysis treatment at station 6 machine 14. Staff, I, the Patient Care Technician (PCT), escorted Patient #6 to the outside waiting area without encouraging or asking Patient #6 to wash their hands. 2. In an observation conducted on 05/21/25 at 9:15 AM, Patient #7 was done with her Hemodialysis treatment at station 1 machine 7. Staff H, PCT, escorted Patient #7 to the outside waiting area without encouraging or asking Patient #7 to wash their hands. In an interview conducted on 5/22/25 at 9:30 AM, the Director of Nursing stated that staff are expected to ask patients and remind them to wash their hands after the dialysis treatments. She further said that some patients do not want to wash their hands after the dialysis treatments. 47207 3. On 05/20/2025, Patient #9 was observed coming in from the waiting area, the PCT did not ask the patient to wash his hands. During an interview conducted on 05/20/2025 at approximately 10:40 AM, Patient #9 was asked if he had washed his hands prior to starting the dialysis treatments, the patient stated no.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 47207 Based on observations and interviews, the facility failed to ensure Staff followed infection control guidelines while decannulating Arteriovenous Fistula (AVF) connections for 2 out 10 Sampled Patients. Patient #4 and Patient #5. Findings include: 1) Patient #5 was observed in his dialysis chair on 5/20/2025 at around 1:42 PM. Staff F was observed on 5/20/2025 at approximately 1:45 PM removing his gloves, cleaning his hands with soap and water and donning new gloves. He pulled over a patient table with a blue sterile pad covering it, on the table was a box of sterile gloves, a box of sterile gauze and a roll of tape. Staff F began to remove the tape and gauze from the first cannulation site. During this time, Staff F was moving the patient’s table around by pulling it from underneath with his gloved hands. Staff F placed the tape and gauze on the table near the box of gauze and gloves; he removed all the tape and gauze from the first needle connection and discarded the needle into an appropriate sharps container. Staff F then removed gauze pads from the box next to the used gauze on the table, opening several packs to create a covering for the first connection. Staff F then used the tape and applied it to the first needle connection. Staff F applied pressure for 3 to 5 minutes and checked to see if there was no bleeding. Staff F proceeded to remove the tape and gauze from the second needle connection site, placing all the gauze and tape on the same table in the same area as the gauze and tape from the first connection site. After completing this task, Staff F removed the tape and gauze and placed them in a biohazard container. Staff F then removed his gloves, washed his hands with soap and water, dried his hands and donned a new pair of gloves from the box on the table. 2) Staff F was then observed to pull the same table over to Patient #4 at approximately 2:30 PM on 5/20/2025. The surveyor stopped Staff F and asked him if there might be another patient table he could use for Patient #4. Staff F left the room and brought back another patient table. Staff F sprayed the table down and allowed it to dry for several minutes and then applied a sterile pad to the top of the table. Staff F then took the box of gloves, the gauze and the tape, from the previous table and put them on the new table. Staff F was observed on 5/20/2025 at approximately 2:40 PM decannulating Patient #4. Staff F began by removing the tape and gauze from the needle site and placing them in a trash container. Staff F removed the needle first placing it on the pad which was on the patient, and then into the sharps container. Staff F then began placing the rest of the tape and gauze on the tabletop containing the boxes of gloves and gauze. Staff F removed the second needle placing it in an appropriate sharps container. Staff H proceeded to place the gauze and tape on the tabletop. Staff F had difficulty getting the blood to staunch from the second needle site, Staff F applied pressure to the site and remained by the patient the entire time, and with each attempt, Staff F placed the bloody gauze on the table top. During an interview conducted on 5/20/2025 at approximately 3:30 PM, Staff F stated that he was very nervous having to be observed.”

“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: 40153 Based on observations, interviews, and record review, the facility failed to ensure expired medications were not available for use during the tour of the patient treatment area. Findings include: In an observation conducted on 05/20/25 at 10:16 AM in the medication refrigerator, a 0.5-milliliter single pre-filled Influenza vaccine revealed an expiration of 05/06/25. In an interview conducted on 05/20/25 at 10:20 AM with the facility’s Director of Nursing, she acknowledged that the influenzas vaccine had expired on 05/06/25. She was told of the findings again in an interview conducted on 05/22/25 at 5:00 PM with the facility’s Administrator.”

“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: 47207 Based on observation and interviews, the facility failed to maintain emergency equipment in appropriate and working order. Findings include: 1) During inspection of the Emergency crash cart on 6/22/2025 around 11:00 AM, the Automated External Defibrillator (AED) was found to be not working properly. The on/off switch was depressed, the AED started its self-inspection and stated during the initiation process “Change batteries”. The DON was asked at around 11:15 AM on 5/22/2025 to explain, she then stated after hearing the AED repeat the same verbiage again “Change Batteries”, “Oh, it does that all the time.” The Administrator came over stating “We just changed those batteries a year ago.” At around 11:20 AM on 05/22/2025, the Administrator left and came back stating that new batteries had been ordered and would here at the facility on 5/23/2025. 2) The facility’s Evacuation cart was also inspected. The log for the evacuation cart was reviewed, the log of the contents did not include the quantity of the items in the evacuation box. When this was brought to the DON’s attention, 5/22/2025 around 11:40 AM, she stated “We will add that to this log.””

“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: 40153 Based on observations, interviews, and record review, the facility failed to ensure that two of the 10 sampled patients (Patient #4 and Patient #5) were seen by a staff member throughout the dialysis treatments. Findings include: In an observation conducted on 05/20/25 at 1:38 PM, Staff F, a Registered Nurse, was performing disconnection of Hemodialysis treatment with an Arteriovenous fistula access site on Patient #5. Staff F was observed multiple times leaving the dialysis treatment room and walking over to the supply room. Staff F was passing through the waiting room, which was located between the supply room and the treatment room. During the multiple visits to the supply room, Patient #5 was not within the eyesight of Staff F. In an observation conducted on 5/20/25 at 2:30 PM, Staff F, a Registered Nurse, was performing disconnection of Hemodialysis treatment with an Arteriovenous fistula access site on Patient #4. Staff F was observed leaving the dialysis treatment room multiple times and walking over to the supply room. Staff F was passing through the waiting room, which was located between the supply room and the treatment room. During the multiple visits to the supply room, Patient #4 was not within the eyesight of Staff F. In an interview conducted on 5/22/25 at 5:00 PM with the Director of Nursing she was told of the findings.”

“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: 40153 Based on observation, interview and record review, the facility failed to provide the correct/appropriate dialysis prescription for Dialysate Flow Rate for 1 of 5 record review sampled patients (Patient #4). Findings include: In an observation conducted on 05/20/25 at 1:30 PM, Patient #4 was in the dialysis treatment chair receiving Hemodialysis. Closer observation showed that Patient #4 was receiving a Dialysis Flow Rate of 600 milliliters (ml) per minute. A record review of Patient #4 showed dialysis orders dated 03/07/25 for a 700 ml Dialysis Flow Rate. In an interview conducted on 05/20/25 at 1:33 PM, Staff F, Registered Nurse, stated Patient #4 ’ s orders for a Dialysis Flow Rate of 700 ml. When asked why Patient #4 was receiving 600 ml and not 700 ml, he said, “I am sorry,” and proceeded to change the flow rate order from 600 ml to 700 ml. She was told of the findings in an interview with the facility’s Director of Nursing on 05/22/25 at 5:00 PM.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 40153 Based on observation and interview, the facility failed to obtain an immunization history regarding COVID-19 vaccine for 1 of the 5 patients reviewed (Patient #3). Findings include: A chart review revealed Patient #3 started on in-house Hemodialysis on 01/31/25. Further chart review showed that no COVID-19 vaccination was offered or tracked for Patient #3. In an interview conducted on 05/21/25 at 4:10 PM, the facility’s Director of Nursing stated that they did not offer the COVID-19 vaccination to Patient #3.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 40153 Based on record review and interview, the facility failed to complete an initial care plan in a timely manner for 3 of 5 record review sampled patients (Patient #4 and Patient #5). Findings include: A review of the facility’s policy titled “Patient Assessment and Plan of Care” dated 2010 showed the following: The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and will include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care will be consistent with current evidence-based, professionally accepted clinical practice standards. A comprehensive assessment will be conducted on all new patients within 30 Calendar days or 13 outpatient dialysis sessions for Hemodialysis beginning with the first outpatient dialysis treatment or per state guidelines. 1. A chart review revealed that Patient #4 was residing in a Nursing Home and started his first outpatient dialysis treatment on 6/29/2024. Further record review revealed no Initial Care Plan was completed for Patient #4. In an interview conducted on 5/21/25 at 2:30 PM, the facility’s Director of Nursing (DON) stated that Nursing Home patients do not have a care plan completed by their team if the resident is not here at the facility and is residing in the nursing home. 47207 2. Record review showed that Patient #5 was admitted to the facility on 6/29/2024. Further record review conducted on 5/21/2025 showed no initial care plan was completed for Patient #5. In an interview conducted on 05/22/2025 at approximately 4:00 PM with the DON, she was told of the findings. The DON stated she was not aware that she had to do a Care Plan for the nursing home patients.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 40153 Based on record review and interview, the facility failed to complete a 90-day care plan in a timely manner for 3 of 5 record review sampled patients (Patient #4 and Patient #5). Findings include: A review of the facility’s policy titled “Patient Assessment and Plan of Care” dated 2010 showed the following: The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs, as identified by the comprehensive assessment and changes in the patient’s condition, and will include measurable and expected outcomes and estimated timetables to achieve these outcomes. The outcomes specified in the patient plan of care will be consistent with current evidence-based, professionally accepted clinical practice standards. A follow-up 90 day re-assessment will be completed to provide information to adjust the patient’s plan of care. 1. A chart review revealed that Patient #4 was residing in a Nursing Home and started his first outpatient dialysis treatment on 6/29/2024. Further record review revealed no 90-day Care Plan was completed for Patient #4. In an interview conducted on 5/21/25 at 2:30 PM, the facility’s Director of Nursing (DON) stated that Nursing Home patients do not have a 90-day care plan completed by their team if the resident is not here at the facility and is residing in the nursing home. 47207 2. Record review showed that Patient #5 was admitted to the facility on 6/29/2024. Further record review showed that no 90 day chare plan was completed for Patient #4. In an interview conducted on 05/22/2025 at approximately 4:00 PM with the DON, she was told of the findings. The DON stated that she was not aware she had to have a 90 day Care Plan for the dialysis patients.”