Fmc - of Metropolis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 49741 Based on document review, observation, and interview, it was determined that the Facility failed to comply with the Condition for Coverage 42 CFR 494.30, Infection Control. Findings include: 1. The facility failed to ensure hand hygiene was performed and personal protective equipment was donned as required. See V113. 2. The facility failed to provide a sanitary environment to minimize the transmission of infectious agents within and between patients. See V122. 3. The facility failed to ensure expired medications were not available for patient use. See V143. 4. The facility failed to ensure the water treatment room, Biotech work room, and storage room floors and counters were maintained in a sanitary environment. See V111. 5. The facility failed to ensure supplies were stored off the floor to prevent contamination. See V117”

“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: 39025 A. Based on document review, observation, and interview, it was determined that the Facility failed to follow infection control precautions by not maintaining a clean, safe, and aesthetically pleasant environment for patient, as required. Findings Include: 1. On 05/27/25 at approximately 11:00 AM, an observational tour of the dialysis treatment room was conducted. The room was observed to be disheveled with too numerous to count trash items on the floor around each dialyzer machines and treatment chairs (1-10), on the stainless steel patient scale, and in the lab area on the treatment floor. The wood paneling on the wall of the treatment center, behind the dialysis chairs, was warped and splintered. Observed in part were plastic cap lids, zip ties, 2” x 2” gauze pads, packets of alcohol pads, and a used face mask. 2. On 5/28/25 the Facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station” (Published 9/5/23), was reviewed and noted, “Procedure: ...6. Pick up all trash or visible medical debris from around the patient chair.” The Facility’s policy titled, “Policy: All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices and restrooms. Walkways must be kept clear of debris and free of clutter.” 3. On 5/27/25 at approximately 2:00 PM, an interview was conducted with the Clinic Manager (E#2). E #2 observed and verbally confirmed that the room should have been cleaned up before staff left the prior treatment day. B. Based on observation and staff interview, it was determined that for 10 out of 10 stations, the Facility failed to ensure the wall boxes/drains were clean and free of buildup. Findings include: 1. On 5/27/25 at approximately 12:20 PM, a tour of the dialysis treatment area was conducted. The Dialysis Wall Boxes/Drains behind dialysis chairs 1-8 housed rusted hose clamps and dark brown/rust-colored stains, as well as crystalized acid sediment on the hose connector sites. The connector boxes behind chairs 9 and 10 contained heavy crystalized acid sediment. 2. The Facility policy title “Cleaning and Disinfecting the Dialysis Station” (Published 9/5/23) was reviewed. It indicated “Cleaning of the Dialysis Wall Boxes: Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood ... Work Surface Cleaning and Disinfection without Visible Blood using Bleach Solutions: All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glisteningly wet and let air dry ...” 3. On 5/27/25 at approximately 1:15 PM an interview was conducted with the Clinic Manager (E#2) and Biomedical Operations Manager (E#3) who both observed all wall units and verbally agreed they have not been cleaned on a regular basis. C. Based on observation, document review, and staff interview, it was determined the End Stage Renal Disease (ESRD) Facility failed to ensure the water treatment room, biotech work room, and storage room floors and counters were maintained in a sanitary environment to minimize the transmission of infectious agents. Findings include: 1. On 05/27/25 between 12:20 PM and 1:30 PM, a tour of the water treatment room, biotech work area, and storage room were conducted with Biomedical Operations Manager (E #3). The following was noted: a. Storage room - Floors were soiled and had debris on floor, dust, and white chemical residue dried on floor. b. Bio-Tech work area - An electronic machine board part, an empty bag, a red cap, and various other debris lay on the floor and under the shelving units. Dust and debris covered counter surfaces. 2. At the eye wash station a yellow repair work order paper had been wet, then dried stuck to the drain on the floor. a. The electrical wall outlet measuring approximately 3 ½ feet in length was completely covered in rust. b. Water Treatment Room - Floors were soiled, debris on floor and under storage rack, white chemical residue and a puddle of water on floor. 1. The acid loop bypass tank had dry acid crystallized covering the connectors on the tank. 2. The acid prep and storage area were soiled with sediment and debris on the floor. 3. The chlorine water testing cart had a heavily soiled chuck pad with spots of black debris where the testing strips were used. Behind the cart on the floor was an open bottle of chlorine test strips. 4. The hot water heater was rusted around the entire bottom surface of the tank. 5. Underneath the rinse ports station on the wall, a pool of water was observed on the floor. 3. The facility policy titled, “General Cleanliness and Infection Control Guidelines” (dated 05/05/25) was reviewed. The policy notes, “ ... All areas must be kept clean and organized, including but not limited to “ ... treatment areas, water/supply rooms, offices, and restrooms. Walkways must be kept clear of debris and free of clutter.” 4. On 05/27/25 at approximately 1:30 PM, an interview with the Biomedical Operations Manager (E #3) was conducted. (E#3) acknowledged and verbally agreed the observations above needed to be corrected and maintained in a sanitary manner.”

“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: 49741 Based on observation, interview, and document review, it was determined for 1 of 2 Patient Care Tech observations, the Facility failed to ensure hand hygiene was performed. Findings include: 1. On 5/28/23 at approximately 11:00 AM, an observational tour of the treatment floor was conducted. The Patient Care Tech (E#6) failed to use hand hygiene and change gloves after disposing items in the trash can, located centrally on the treatment floor, and then back to patient to drop pre-packaged items to patient in chair #4. 2. On 5/29/23 at approximately 11:00 AM, the policy titled, “Hand Hygiene” was reviewed. The policy stated, “Policy: ...Hands Will Be ... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: ... After contact with inanimate objects near the patient ... After contact with other objects within the patient station or treatment space.” 3. An interview was conducted with the Clinic Manager, (E#2) on 5/28/25 at 1:00 PM. E#2 stated, “I will talk to (E#6) regarding this situation. She is a float, but should have been using hand hygiene and changing gloves after leaving the patient chair to dispose items into the trash.””

“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: 39025 Based on document review, observation, and interview, it was determined the End Stage Renal Dialysis center (ESRD) failed to ensure supplies were stored off the floor to prevent contamination. Findings Include: 1. On 05/27/25 at 12:20 PM, an observational tour was conducted of the water room with Bio-med Operations manager, employee (E#3). Observed sitting directly on the floor was one large box of acid loop tubing. 2. The facility policy titled, “Storage of Supplies” dated 04/05/21 was reviewed. It noted, “... supplies ... must be stored off the floor ... “ 3. On 05/25/25 at 12:25 PM, an interview was conducted with (E#3). (E#3) observed and verbally agreed the box of tubing should be stored off the floor and on a pallet or shelving.”

“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: 49741 Based on document review, observation, and interview, it was determined that for 1 of 2 technicians (E#5) observed cleaning and disinfecting dialysis stations, the Facility failed to follow infection control precautions by not cleaning/disinfecting equipment, as required. Findings Include: 1. On 5/28/25 at approximately 11:30 AM Patient Care Technician (E#5) was observed cleaning dialysis station 10. After cleaning all surfaces, E#5 did not allow the dialysis chair to fully air dry before returning to sitting position and closing the arms of the chair. 2. On 5/28/25 the Facility’s policy titled, “Cleaning and Disinfecting the Dialysis Station” (Published 9/5/23), was reviewed and noted, “Work Surface Cleaning and Disinfection without Visible Blood using Bleach Solutions: All work surfaces shall be cleaned and disinfected with 1:100 bleach solution after completion of procedures. Make the surface glisteningly wet and let air dry ...” 3. On 5/28/25 at approximately 2:30 PM, an interview was conducted with the Clinic Manager (E#2). E #2 observed and verbally confirmed that the dialysis chairs should be fully reclined with chair arms open to allow adequate time for surfaces to air dry in order to provide sufficient disinfectant contact time.”

“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: 39025 Based on observation, facility documentation, and staff interview it was determined the End Stage Renal Dialysis (ESRD) center failed to ensure outdated medications and biological’s were not available for patient use. Findings Include: 1. On 05/27/25 at approximately 11:00 AM an observational tour of the dialysis treatment room was conducted. The following was noted - a. 4 bottles of Germ Star instant hand sanitizer, 16 oz (ounce) with an expiration date of 03/25. b. A 1 ml (milliliter) vial Epoetin 20,000 U (units)/ml, vial found in refrigerator opened, expiration date 1/29/25. c. A 3 ml vial BD Vacutainer PST (plasma separating tube) Gel and Lithium Heparin 56 U, found on counter with puncture hole. 2. A facility policy titled, “Sequestering Medications” dated 09/26/18 was reviewed. It noted, “ ... Medications that are expired, defective, damaged, ... may pose a significant health threat and safety risk to paients and need to be sequestered.” 3. On 05/27/25 at approximately 1:00 PM, Clinic Manager (E#2) observed and acknowledged the expired items stating, “These expired items should have been discarded.””

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 49741 Based on observation, document review and interview, it was determined for 2 of 9 (Stations #1 and 6) patients, the Facility failed to ensure that vascular access was visible at all times. Findings include: 1. On 5/28/25 at approximately 11:30 AM, the following patients had their CVC access site covered: a. Patient in Station #1 had a blanket covering the patient’s CVC access site in the right upper chest. b. Patient in Station #6 had a blanket covering the patient’s CVC access site in the right upper chest. 2. The policy titled, “Patient Monitoring and Safety Checks During Hemodialysis Treatment” (published 9/5/2023) was reviewed on 5/29/2024 at approximately 10:00 AM. The policy indicated under “Safety Check-Access: ...Confirm each patient’s face and access are uncovered.” 3. On 5/28/25 at approximately 1:00 PM, an interview was conducted with the Clinic Manager (E#2). E #2 stated, “I will have an in-service regarding this and other issues. All patients must have their access sites visible at all times.””

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 The dialysis facility must provide or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter. This Standard is not met as evidenced by: 39025 Based on review of observation, laboratory contract documentation, and staff interview, it was determined the End Stage Renal Dialysis (ESRD) center failed to ensure biologicals had not exceeded the expiration date. Findings include: 1. On 05/27/25 at 11:00 AM, an observational tour of the patient treatment room was conducted with Clinic Manager (E#2). The following items were noted: a. In the mini refrigerator for lab specimens were two lavender top tubes of blood. One tube was labeled (Pt#6) DOB (date of birth): 08/20/48, dated 05/23/25; The second tube was labeled (Pt#2) DOB: 11/28/74, dated 05/23/25. b. On the counter beside the lab refrigerator were two yellow top serum separating tubes of blood. One tube was labeled (Pt#5) and the DOB and date were illegible; the second tube was labeled (Pt#7) DOB: 02/09/68, dated 05/26/25. 2. A facility contract titled, “... Laboratory Services Agreement”, was reviewed. It noted, “ ... 10. Each facility shall be responsible for all proper preparation and packaging of specimens for shipment to (name of lab) ... “ 3. On 05/27/25 at 1:00 PM, (E#2) observed and acknowledge the purple top tubes in the refrigorator and the yellow top tubes on the counter. (E#2) stated, “The purple tops are good for 2 days and the yellow tops are good for 7 days. I don’t know why there was not a pick-up on Friday, 05/23/25, so the purple tops are no longer good. The yellow tops are not good even with the date of 05/26/25, since they were left out on the counter.” When asked what the lab pick-up schedule was for this center, (E#2) stated, “We use Fedex and they pick-up on Monday, Wednesday, and Friday, but we can call and request a pick-up at any time.” .”