Fmc - Irvington

“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: 51279 Based on observation, record review, and interview, the facility failed to ensure the comprehensive Emergency Preparedness (EP) program met all requirements to meet the health, safety, and security needs of their staff and patient population (E-0003), failed to develop the emergency plan based on and documented facility -based and community-based risk assessment using an all-hazards approach (E-0006), failed to collaborate with local/regional officials to ensure the local officials are aware of dialysis facility needs in an emergency (E-0009), failed to ensure emergency equipment are not expired (E-0028), failed to ensure a communication plan is in place and updated annually (E-0029), and failed to perform annual emergency preparedness testing (E-0039) for 1 of 1 standalone dialysis facility . The cumulative effect of these systemic problems resulted in the facility being found out of compliance with the condition, Medicare and Medicaid Participating Providers and Suppliers, 42 CFR 494.62. Findings include: 1. A review of a Fresenius Kidney Care policy dated 02/03/2025 titled “Emergency Medications, Equipment and Supplies” indicated but was not limited to, “ ... An emergency evacuation box must ... Be checked monthly or after use for contents, expiration dates ...” A review of a Fresenius Kidney Care document revised 08/02/2017 and titled “Emergency Disaster Responsibility Guidelines” indicated but was not limited to, “ ... Prepare the Hazard Vulnerability Assessment for each facility ... Update each facility’s disaster plan and emergency contact information directory ... Conduct a table top drill, Document Drills ... ensure the availability of disaster assets ... Clinical Manager ... Participate in the completion of the Hazard Vulnerability Assessment ... Maintain current listings of patients and staff including local contact, emergency contact, and evacuation information. 2. During a review of the emergency preparedness suitcase on 03/03/2025 at 10:30 AM, observed the following: a box of 200 size large exam gloves had an expiration date of 05/2022, a box of 200 size small exam gloves had an expiration date of 08/2022, 1 box of medical face masks had an expiration date of 05/22/2023, 100 alcohol prep pads had an expiration date of 11/2023, 1 bottle of hand sanitizer had an expiration date of 03/2024, 22 - 4”x4” non-woven sponges had an expiration date of 11/2020, 2 - 2”x2” non-woven sponges had an expiration date of 11/2020, 2 - blood collection kits had an expiration date of 03/31/2023, and 2 - 3 mL syringes with 20 G needles had an expiration date of 09/30/2023. During an interview on 03/03/2025 at 10:45 AM, the CM indicated Person 3 was responsible for reviewing the EP suitcase and Person 3 was not looking at the supplies if there were expired items. 3. A review of the Emergency Preparedness (EP) Binder revealed the following: A Fresenius Kidney Care document dated April 2021 - V9 titled “FKC Facility Emergency Information Directory” indicated but was not limited to, “Director of Operations / Area Manager Person 2”. A Fresenius Kidney Care document dated June 2017 and titled “FKC Emergency Disaster Staff Contact Information Sheet”. A facility document revised 12/2008 and titled “Emergency Shelter List by County”. A review of a Fresenius Kidney Care document dated 10/03/2012 and titled “Irvington Home Facility Specific Fire Safety Plan”. A review of a facility document dated 10/04/2018 and titled “Dialysis Facility Incident After Action Review / Improvement Plan” indicated but was not limited, “ ... incident active shooter ...”. A facility document dated 09/25/2024 and titled “Emergency Disaster Patient Contact List”. The EP binder failed to evidence an updated “Emergency Disaster Patient Contact List” The EP binder failed to evidence annual review and revision, a communication plan, and documented facility-based and community-based risk assessment using an all-hazards approach. During an interview on 03/03/2025 at 2:13 PM, the CM indicated “it’s not real updated” while providing the emergency preparedness binder. During an interview on 03/03/2025 at 4:07 PM, the CM indicated the facility-based and community-based risk assessment using an all-hazards approach was not printed off and included in the binder. When queried about the document titled “FKC Facility Emergency Information Directory,” the CM indicated the documented Director of Operations needed changed, the overall document needed updated, and the document should be updated annually. When queried about the patient list in the EP binder, the CM indicated the patient list should be updated quarterly. When queried about the revision date of the document titled “Emergency Shelter List By County,” the CM indicated “my whole book needs updated”. When queried about the fire plan dated 2012, the CM indicated the fire plan remains the same but should be reviewed annually and dated to reflect. When queried about emergency preparedness testing, the CM indicated the facility had not completed testing in a couple of years. When queried about the communication plan the CM indicated the order they call staff is dependent on what the scenario is. When queried if there was a call tree, the CM indicated they were unclear if a call tree and questioned the Director of Operations. The Director of Operations confirmed there is a call tree. When queried how often a communication plan should be reviewed, the CM indicated annually.”

“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: 47343 Based on observation, record review, and interview, the facility failed to ensure supplies were not stored under sinks for 6 of 6 patient exam rooms with a stand alone home dialysis program. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 11/04/2024, titled “General Cleanliness and Infection Control Guidelines,” indicated but was not limited to, “ ... The purpose of this policy is to provide guidance for the FKC staff on preventing the spread of infectious disease and maintaining a clean, safe, and aesthetically pleasant environment for patients, staff, and visitors ... Clean supplies may not be kept under dirty sinks ...” 2. During a flash tour of the facility on 03/03/2025 at 9:40 AM, the following observations were made: An observation in Patient Exam Room 3 evidenced a small trash can under the sink without a cabinet under it. An observation in Patient Exam Room 4 evidenced a small trash can and a patient scale under the sink without a cabinet under it. 3. During a walk-through of the Patient Exam Rooms on 03/03/2025 at 1:26 PM, the following observations were made: An observation in Patient Exam Room 1 evidenced a small trash can under the sink without a cabinet under it. An observation in Patient Exam Room 2 evidenced a small trash can under the sink without a cabinet under it. An observation in Patient Exam Room 5 evidenced a small trash can under the sink without a cabinet under it. An observation in Patient Exam Room 6 evidenced a small trash can, EZ Gel Drain clean bottle, and a black filing tote under the sink without a cabinet under it. 4. During an interview with the CM on 03/03/2025 at 4:15 PM, they indicated the sinks were supposed to have nothing under them.”

“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: 47343 Based on observations and interviews, the facility failed to ensure expired items and medications were removed from 6 of 6 Patient Exam Rooms and 1 of 1 medication room for a stand alone home dialysis program. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 02/06/2023 titled “Medication Preparation and Administration” indicated but was not limited to, “ ... Monitoring Expired Medications: Expiration dates for all stored medications are to be monitored on a monthly basis. Expired medications are to be discarded ...” 2. During a flash tour of the facility on 03/03/2025 evidenced, the following observations were made: An observation made in the Medication room evidenced 23 Tuberculosis syringes with an expiration date of 10/31/2024 and a 10 milliliter (ml) syringe with an expiration date of 11/30/2024 in the top drawer next to the sink. An observation made in Patient Exam Room 2 evidenced a 25 gauge (G) safety glide needle with an expiration date of 06/2020 and a 21 G safety glide needle with an expiration date of 10/2020 in the top drawer next to the sink. A single pair of exam gloves, with an expiration date of 05/01/2024, were in the cabinet above the sink. An observation made in Patient Exam Room 3 evidenced a pair of exam gloves with an expiration date of 08/01/2021 in the drawer right next to the sink. A 23 G safety needle with an expiration date of 05/09/2021 and a 23 G safety needle with an expiration date of 02/08/2021 in the top middle drawer next to the sink. An observation made in Patient Exam Room 4 evidenced 2 pairs of sterile exam gloves with an expiration date of 03/2021, a 30 ml syringe with an expiration date of 09/30/2022, and 2 boxes from Entity 1 with an expiration date of 02/28/2025 in the cabinet above the sink. 3. An observation of Patient Exam Room 1 on 03/03/2025 at 10:40 AM evidenced a 25 G safety glide needle with an expiration date of 11/30/2021 in the drawer next to the sink. 4. An observation of the medication room on 03/03/2025 at 11:00 AM, the CM opened the locked medication cabinets, evidenced 20 vials of 50 milligram (mg) Venofer (a medication for iron deficiency) with an expiration date of 01/20/2025. During an interview with Registered Nurse 3 on 03/03/2025 at 11:10 AM, they indicated they were the ones to check expiration dates on the medications. They explained they only used the 100mg vials of Venofer, but should have seen them and disposed of them when they expired. 5. During an interview with the CM on 03/03/2025 at 10:45 AM, they indicated the expired items in the patient exam rooms 1- 5 and the medication room were inexcusable and there should not be so many expired items. 51279 6. During a review of the clear three drawer organizer in Patient Exam Room 5 on 03/03/2025 at 10:03 AM, observed the following: 17 - A.V. Fistula (Arteriovenous Fistula, connection between an artery and vein used for dialysis) Needle Set 17 G x 1” had an expiration date of 12/30/2024, 5 - A.V. Fistula Needle Set 17 G x 1” had an expiration date of 06/30/2024, 3 - Button Hole Needle Settle with Anti-Stick Dull Bevel 15 G x 1.25” had an expiration date of 08/31/2021, 3 - A.V. Fistula Needle 15 G x 1” had an expiration date of 01/20/2025, 5 - Hemodialysis (medical treatment that removes waste products and excess fluid from the body when the kidneys are unable) Fistula Needle Set 15 G x 1” had an expiration date of 01/31/2025, 1 - Hemodialysis Fistula Needle Set 15 G x 1.25” had an expiration date of 01/31/2025, Review of the cabinet drawer in Patient Exam Room 5 observed the following: 23 - clear top vacutainer blood collection tubes had an expiration date of 10/31/2024. 7. During a review of the clear three drawer organizer in Patient Exam Room 6 on 03/04/2025 at 1:26 PM, observed the following: an open box with 24 remaining ChloraPrep One-Step had an expiration date of 01/2024. Review of the cabinet drawer in Patient Exam Room 6 observed the following: 8 - gold top vacutainer blood collection tubes had an expiration date of 01/31/2025. During an interview on 03/04/2025 at 4:06 PM, the CM indicated they would address the expired supplies found in Patient Exam Room 6.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 47343 Based on observation, record review, and interview, the facility failed to ensure the building was maintained to ensure the safety of patients and staff and boxes stored appropriately for 1 of 1 stand-alone home dialysis programs. Findings Include: 1. A review of a Fresenius Kidney Care policy dated 11/04/2024, titled “General Cleanliness and Infection Control Guidelines” indicated but was not limited to, “The purpose of this policy is to provide guidance for FKC staff on ... maintaining a clean, safe, and aesthetically pleasant environment for patients ... All areas must be kept clean and organized ...” 2. A review of a Fresenius Kidney Care policy dated 04/05/2021, titled “Storage of Supplies” indicated but was not limited to, “ All clean or sterile supplies ... must be stored off the floor ...” 3. During a flash tour of the facility on 03/03/2025 at 9:40 AM, the following observations were made: An observation of the door used as the employee entrance evidenced a one inch crack where light shone through from the outside at the bottom of the door with a cool breeze. An observation of the door to the outside in the storage room, where the Peritoneal Dialysis (a thin catheter inserted into the abdomen to remove excess waste from the blood when the kidneys failed) supplies were kept, evidenced a cool breeze in the room and light from the outside from the small half inch opening along the bottom of the right door and a half inch opening in the middle at the bottom where the two doors connected. The floor in front of the door evidenced 59 wood chips of varying sizes, with the biggest at 2 inches long. An observation of the Biohazard room evidenced in the corner on the floor next to the door a clump, around six inches in diameter, of cobwebs, leaves, dirt, and dust. The dust and leaves followed along the border of the wall and the floor an inch in width to the back right corner. The floor in front of the door had a sign titled “Medical Waste” coated in dust. The floor next to the back wall evidenced a red cap with a diameter of three inches, leaves, dust, wood chips, and pieces of paper in a clump lining the back wall as long as a foot along the back wall. The room included four unmarked boxes on the floor. During an interview with the CM on 03/03/2025 at 10:45 AM, when queried regarding the doors, they indicated they needed to put a weather strip placed under the doors. When queried regarding the wood chips in front of the door to the outside of the Peritoneal Dialysis storage room and the dirty clumps in the biohazard room, they indicated they needed to clean the rooms. The CM indicated they would break down the boxes and get rid of them now.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 51279 Based on record review and interview, the facility failed to update the Plan of Care (POC) monthly for 1 of 1 active unstable patient. (Patient #1) Findings Include: 1. A Fresenius Kidney Care policy dated 07/03/2023 titled “Comprehensive Interdisciplinary (IDT) Assessment and Plan of Care” indicated but was not limited to, “ ... Unstable patients must be reassessed by the IDT monthly. Monthly reassessment and any POC updates related to the reason the patient is considered “unstadble” must be documented ...” 2. Review of an undated facility document titled, “Patients listed as Unstable over the last 90 days” indicated but was not limited, “ ... Patient #1 3/24/2025 HHD, unstable for not meeting adequacy” 3. A review of Patient #1’s clinical record evidenced a POC with a meeting date of 11/11/2024, last patient status stable, and next POC meeting 11/11/2025. Patient #1’s clinical record failed to evidence care plan meeting since 11/11/2024. Review of Patient #1’s clinical record revealed a Provider note dated 01/21/2025 and signed by Other Physician 3. The note indicated but was not limited to, “ ... Patient is not stable ... Comments: Unstable ...” Review of Patient #1’s clinical record revealed a Provider note dated 02/24/2025 and signed by Other Physician 3. The note indicated but was not limited, “ ... Patient is not stable ... Comments: Unstable, non-compliant with treatment ... does not like to sit down for multiple hours ...” Review of Patient #1’s clinical record revealed a Psychosocial Progress note dated 02/24/2025 and signed by MSW 1. The note indicated but was not limited to, “ ... Patient made unstable ...” During an interview on 03/03/2025 at 12:19 PM, the CM indicated Patient #1 had a POC meeting in December, and the facility was planning to make the patient unstable this month. During an interview on 03/04/2024 at 4:12 PM, RN 2 indicated POC meetings are monthly if a patient is deemed unstable. When queried what would classify a patient as unstable, RN 2 indicated if a patient has frequent hospitalizations or is noncompliant with treatment. During an interview on 03/04/2025 at 4:37 PM, the CM indicated POC meetings are completed monthly until the patient is deemed stable. When queried about the Provider note from 01/21/2025 indicating Patient #1 is unstable, the CM indicated Patient #1 should have been made unstable all of these months.”