Excel Renal Care Services

“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: 39802 Based on document review, observation, and interview, the Facility failed to ensure that clean supplies and medications were not stored in or nearby dirty areas. Findings include: 1. The Facility’s policy titled, “Infection Control Guidelines” (effective 09/2017), was reviewed and required, “...Sinks in the clinical area must be designated as clear or dirty. Clean meaning the preparation, handling, storage of medications and unused supplies and equipment; and dirty meaning where blood specimens and dirty equipment are handled. Staff must be aware of the separation of clean and dirty areas to prevent cross-contamination...” 2. During a tour of the dialysis training room and the storage office on 09/29/2025, the following were observed: - At approximately 10:30 AM, there were two jars of clean supplies (sterile cottoned tipped applicators and tongue depressors) next to the dirty sink in the dialysis training room. - At approximately 11:00 AM, there was a vial of heparin (blood thinner medication) noted in the storage office that was placed on an open shelf just above the centrifuge (equipment used process blood specimens). 3. An interview with the Medical Director (MD#1) on 09/30/2025, at approximately 11:50 AM. MD#1 stated that clean supplies and medications should not be stored in dirty areas. MD#1 stated that the centrifuge is used by the clinic and not this Facility but they share the space. MD#1 stated that the heparin is used for the Facility’s dialysis patients and should not have been left there.”

“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: 39802 Based on document review and interview, for 2 of 2 home hemodialysis (HHD) patient (Pts. #3 and #4) records reviewed, the Facility failed to ensure that the dialysis prescription ordered was evaluated and updated as needed. Findings include: 1. The Facility’s policy titled, “Physician’s Orders for Treatment” (effective 09/2017), was reviewed and required, “Orders for treatment will be in writing and signed, dated and time noted by the prescribing physician. Routine ‘standing’ orders for treatment shall be updated...” 2. The Facility’s policy titled, “Assessment of Patient” (effective 09/2017), was reviewed and required, “...The adequacy of the patient’s dialysis prescription must be assessed on an ongoing basis...” 3. The clinical record of Pt. #3 was reviewed on 09/29/2025. Pt. #3 was admitted on 04/27/2024 with a diagnosis of end-stage renal disease (ESRD). A dialysis prescription order, dated 01/31/2025, included hemodialysis treatments for 3 days per week with a dry weight of 63 kilograms (kg). Treatment records from 09/13/2025-09/27/2025 were reviewed and indicated that Pt. #3 was completing dialysis treatments 4 times per week. Post-treatment weights were in the 53-54 kg range (nearly 10 kg less than the target dry weight ordered). The record lacked documentation of re-evaluation and update of the prescribed orders. 4. The clinical record of Pt. #4 was reviewed on 09/29/2025. Pt. #4 was admitted on 11/08/2021 with a diagnosis of ESRD. A dialysis prescription order, dated 12/02/2024, included hemodialysis treatments for 3 days per week with a dry weight of 76 kg and dialysate volume of 25 L (liters). Treatment records from 09/15/2025-09/29/2025 were reviewed and indicated that Pt. #4 was completing dialysis treatments 3 times per week with a dialysate volume of 35 L (10 L more than ordered). Post-treatment weights were in the 80--81 kg range (nearly 5 kg more than the target dry weight ordered). The record lacked documentation of re-evaluation and update of the prescribed orders. 5. An interview was conducted with the Medical Director on 09/29/2025, at approximately 11:50 AM. MD#1 stated that both patients have been running on different prescriptions for at least a few months now but they forgot to update the dialysis prescription orders in the system.”

“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: 39802 Based on document review, observation, and interview, the Facility’s Medical Director failed to ensure that outdated supplies and medications were disposed of so that they were not available for use on patients. Findings include: 1. The Facility’s policy titled, “Control and Storage of Medications” (effective 04/2017), was reviewed and required, “...Medication inventory is to be checked monthly. Assess for: ...expired (outdated) medication... Inspect each open vial and bottle each day for the following: Expiration date; Date (month/day/year) vial was opened... Discard medication if: Expired; Opened without completed date and/or initials; Opened for longer than 30 days... for multi-dose vials...” 2. During a tour of the dialysis training room and storage areas on 09/30/2025 between approximately 10:30 AM and 11:15 AM, the following was observed: - In the medication cabinet, there was a box of cefazolin (antibiotic) vials with an expiration date of 04/2025 and a tub of sani-cloth wipes (disinfectant wipes) with an expiration date of 04/2023. - In the dialysis training room, there were 5 bottles of Alcavis (skin disinfectant solution) with expiration dates ranging from 04/12/2024-10/11/2024. One of the 5 bottles was opened and lacked an opened date (6 month shelf life after opening per manufacturer’s instruction on the bottle). There were also 12 lab tubes with expiration dates between 05/31/2025-07/31/2025; 5 boxes of alcohol prep pads which expired 07/2025; 3 minicaps with povidone iodine (disinfectant) with expiration dates between 06/30/2023 and 07/28/2024; 1 tube of mupirocin (antifungal cream) that expired March 2024; 3 cefepime (antibiotic) vials that expired 06/2024; and 2 bags of 2.5 % Dextrose PD (peritoneal dialysis) solutions that expired 06/2025. - The emergency bag contained 5 chloraprep (skin disinfectant) swabs that expired 07/2020 and 2 minicaps with iodine that expired 05/31/2025. - All of the outdated items were found in areas that was mixed in with non-expired supplies and were not labeled for training use only. 3. An interview was conducted with the Medical Director (MD#1) on 09/29/2025, at approximately 11:50 AM. MD#1 stated that supplies should be checked at least monthly for expiration dates. MD#1 stated that if certain medications or solutions have a limited shelf-life after opening, they should be labeled with the date it was opened and discarded when outdated. MD#1 stated that if supplies are going to be used for training purposes only (not for patient use) then they should be labeled ‘not for patient use’ or ‘for training purposes only.’”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 34411 Based on document review and interview, it was determined that the Facility failed to ensure that the Emergency Preparedness Plan was reviewed annually, as required. Findings include: 1. The Facility’s “Emergency Plan” was reviewed, and required, “...the Emergency Plan must be reviewed annually...” 2. The Facility’s Emergency Plan, included the last review date was 11/30/2018. The plan lacked a review or update annually, as required. 3. On 4/25/2024 at 9:50 AM, an interview was conducted with the Home Hemodialysis Registered Nurse (E #3). E #3 stated that the Emergency plan should be updated every year.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 34411 Based on document review, observation, and interview, it was determined that for 1 of 1 emergency cart, the Facility failed to ensure that emergency medications which were available for use were not expired. Findings include: 1. The Facility’s policy “Monthly Emergency Cart Checklist” (2024), was reviewed. The checklist included emergency medications and supplies. The checklist required staff to review the emergency cart for expired medications and supplies. Epinephrine and Diphenhydramine (Benadryl) were included on the checklist. 2. On 4/18/2024 at 11:10 AM, an observational tour of the facility was conducted. During the tour, the emergency cart was observed for the required contents. The emergency cart contained the following: - Epinephrine 0.3 milligrams (expired 7/2023) - Benadryl 50 milligrams (expired 3/2024) 3. On 4/18/2024 at 11:15 AM, an interview was conducted with the Nurse Practitioner (E #1). E #1 stated that medications in the emergency cart should not be expired, and the nurse should check them monthly and reorder as needed.”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 34411 Based on document interview and interview, it was determined that for 3 of 3 personnel files of direct care staff reviewed (E #1, E #3, E #6), the Facility failed to ensure that annual infection control training was completed, per policy. Findings include: 1. The Facility’s Infection Control Guidelines (dated 9/2017), was reviewed, and required, “...The center will schedule an infection control inservice for all patient care and technical personnel to review all written guidelines at least annually...” 2. The Facility’s “Initial & Annual Skills Checklist” was reviewed and required annual infection control requirements for the direct care staff. 3. The personnel files of the Nurse Practitioner (E #1), the Registered Nurse (E #3), and the Patient Care Technician (E #6) were reviewed. The personnel files lacked the required infection control checklist. 4. On 4/25/2024 at 12:15 PM, an interview was conducted with the Home Hemodialysis Registered Nurse (E #3). E #3 stated that the staff are required to complete annual infection control training. E #3 confirmed and acknowledged the personnel files lacked this required training.”

“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: 34411 Based on document review, observation, and interview, it was determined that for 1 of 1 medication refrigerator, the Facility failed to ensure that expired medications were not readily accessible for patient use. Findings include: 1. The Facility’s policy titled, “Medications: Handling, Storage and Disposal” (dated 8/2022), was reviewed, and required, “To ensure that the facility acquires, stores, and disposes of medications safely and in a manner that meets regulatory requirements...The Nurse will monitor on a monthly basis the number of medications on hand...items will be inspected for...expiration dates...” 2. On 4/18/2024 at 11:10 AM, an observational tour of the Facility’s Training Room that included the medication refrigerator, was conducted. The medication refrigerator contained 4 syringes of the pneumonia vaccine with an expiration date of 1/2024 (3 months past expiration). 3. On 4/18/2024 at 11:15 AM, an interview was conducted with the Nurse Practitioner (E #1). E #1 stated that nurses check for expirations monthly and that expired medications should be discarded.”

“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: 32741 Based on document review and interview, it was determined that for 2 of 2 home hemodialysis clinical records (Pt. #3 & Pt. #4) reviewed for blood flow, the Facility failed to ensure the blood flow rate was maintained, as ordered. Findings include: 1. On 4/25/2024, the Facility’s policy titled, “Treatment Documentation” (undated) was reviewed and indicated, “Purpose - to ensure each patient treatment is documented and sent to the center enabling patient surveillance and monitoring. Policy - The patient/support staff will document each treatment and send to the center ensuring the center’s requirements for pretreatment, intradialytic, and post-treatment information are met.” 2. On 4/25/2024, Pt. #3’s home hemodialysis treatment records dated 4/4/2024 thru 4/18/2024 were reviewed and noted: -Pt. #3 was admitted to the Facility on 7/22/20022 for home hemodialysis. -Pt. #3’s physician orders for home hemodialysis dated 3/16/2024 included, “blood flow [rate] 300 or more.” -Pt. #3’s home hemodialysis treatment record dated 4/7/2024 from 5:00 PM to 8:30 PM lacked documentation of blood flow rate from 6:00 AM to 8:30 AM. -Pt. #3’s home hemodialysis treatment record dated 4/9/2024 from 8:57 PM to 12:27 AM (on 4/10/2024) lacked documentation of blood flow rate from 9:57 PM (on 4/9/2024) to 12:27 AM (on 4/10/2024). -Pt. #3’s home hemodialysis treatment record dated 4/15/2024 from 11:12 AM to 2:42 PM lacked documentation of blood flow rate from 12:12 PM to 2:42 PM. 3. On 4/25/2024, Pt. #4’s home hemodialysis treatment records dated 4/6/2024 thru 4/18/2024 were reviewed and noted: -Pt. #4 was admitted to the Facility on 1/5/2019 for home hemodialysis. -Pt. #4’s physician orders home hemodialysis dated 9/19/2022 included, “blood flow rate 300-500 as tolerated.” -Pt. #4’s home hemodialysis treatment record dated 4/13/2024 from 4:00 AM to 7:30 AM lacked documentation of blood flow rate from 5:00 AM to 7:30 AM. -Pt. #4’s home hemodialysis treatment record dated 4/14/2024 from 4:07 AM to 7:37 AM lacked documentation of blood flow rate from 5:07 AM to 7:37 AM. 4. On 4/25/2024 at 11:00 AM, an interview was conducted with the Registered Nurse (E #3). E #3 stated that Pt. #3 and Pt. #4’s blood flow rate should be documented for each treatment.”