Fmc Summer

“IC-SINGLE USE VIALS CFR(s): 494.30(a)(1)(i) Intravenous medication vials labeled for single use, including erythropoietin, should not be punctured more than once. This Standard is not met as evidenced by: 49570 Based on facility policy review, observation, and interview, the facility failed to ensure infection control measures were taken on 1 of 2 (04/28/2025) observation days by allowing single dose vials to be used as multi-dose vials. The findings included: 1. Review of facility policy, “Medication Preparation and Administration” published 02/06/2023 revealed, “ ...Discard single-dose vials after use. Never reuse for another patient. For single dose vials, never puncture the vial twice ...” 2. Observations on the treatment floor on 04/28/2025 at 10:28 AM, revealed 3 single dose medication vials (2-Diphenhydranmine (used to treat allergies or allergic reactions) 50mg/ml vial and 1-Ondansetron (used to treat nausea) 4mg/2ml vial) being utilized as multi-dose vials. The rubber septum had been punctured more than once on each vial. 3. During an interview on 04/28/2025 at 10:33 AM, the CN stated that single dose vials were used for multiple patients and discarded after 24 hours. During an interview on 04/29/2025 at 3:53 PM, the CM stated that single dose vials were supposed to be discarded after a single patient use. The CM stated single dose vials should never be used as a multi-dose vial.”

“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: 46831 Based on facility policy review, observation, and interview, the facility failed to ensure medications were labeled properly with an open date, time, and initials of the nurse on 1 of 2 (04/28/2025) observation days . The findings included: 1. Review of facility policy, “Medication Preparation and Administration” dated 02/06/2023, revealed, “...When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (If allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials ...To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened...Label any open multi-dose vial that is not used immediately and store vial accordingly...” 2. Observations on the treatment floor on 04/28/2025 at 9:10 AM, revealed the following unlabeled medications: One (1) vial of Ondansetron (used to treat nausea) 4 mg/2mL vial with no open date, time, or initials present. Two (2) vial of Diphenhydramine (used to treat allergies or allergic reactions) 50 mg/mL with no open date, time, and initials present. One (1) bottle of LiquaCel (protein supplement) with no time, and initials present. Two (2) bottles of LiquaCel with no open date, time, and initials present. Three (3) bottles of Calcium Carbonate (used as an antacid or calcium supplement) 750 mg tablets with no open date, time, and initials present. One (1) bottle of Acetaminophen (used to treat mild to moderate pain) 325 mg tablets with no time present. One (1) vial of Heparin (used to keep blood from clotting) with no open date, time, and initials present. One (1) bottle of Calcitriol (vitamin D) 0.25 mcg capsules with no date, time, and initials present. One (1) bottle of Calcitriol 0.5 mcg capsules with no time and initials present. One (1) bottle of Cinacalcet Hydrochloride (used to treat hyperparathyroidism) 90 mg tablets with no time and initials present. One (1) bottle of Clonidine Hydrochloride (used to treat high blood pressure) 0.2 mg tablets with no time and initials present. 3. During an interview on 04/28/2025 at 10:10 AM, the CM verified the above medications either had no open date, no time present, or not initialed by the nurse.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 46831 Based on facility policy review, observation, and interview, the facility failed to provide a safe environment by not locking 1 of 1 crash carts located on the treatment floor and by not ensuring expired supplies and medications were discarded before their expiration date. The findings included: 1. Review of facility policy, “Storage of Supplies” dated 04/05/2021, revealed, “...Supplies must be rotated First in-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date...” Review of facility policy, “Medication Preparation and Administration” dated 02/06/2023, revealed, “...Monitoring Expired Medication ...Expiration dates for all stored medications are to be monitored on a monthly basis...Expired medications are to be discarded via [Named ESRD Company] off-site return program or in accordance with local and/or state law...” Review of facility policy, “Emergency Medications, Equipment and Supplies” dated 02/03/2025, revealed, “ ...An emergency cart, sometimes called ‘crash cart’ ...The Emergency cart must be locked when not in use...The Emergency cart must be checked monthly or after use for contents, expirations dates...Items approaching expiration must be reordered and replaced prior to the actual expiration date ... An emergency evacuation box must be checked monthly ...for ...expiration dates ...Items approaching expiration must be reordered and replaced prior to the actual expiration date ...” 2. Observations on the treatment floor on 04/28/2025 at 9:10 AM revealed the following expired supplies: Fifty-Two (52) Cotton Tip Applicators with an expiration date of 08/2022 Four Hundred (400) Cotton Tip Applicators with an expiration date of 12/07/2024 Observations at the crash cart on 04/28/2025 at 10:30 AM revealed the following expired supplies: Four (4) Yankauer (medical suction tool) with Tubing with expiration date of 06/03/2024 EMERGENCY BOX Fifty (50) Non-Woven Sponges (2x2) with expiration date of 03/2025 Nine (9) IV Needles with expiration date of 02/28/2022 Observations in the back storage room on 04/28/2025 at 12:02 PM revealed the following expired supplies: Five (5) bottles of Pure Bright Germicidal Ultra Bleach with expiration dates of 02/08/2025 (2) and 02/19/2025 (3) Seven (7) Yankauer with tubing with expiration dates of 12/01/2024 (2) and 04/02/2025 (5) Ninety-Eight (98) Serum Blood Vacutainer (used to transport and process blood for testing) with expiration date of 03/31/2025 Five (5) Culture Swab Plus with expiration date of 09/30/2024 Nine (9) sterile collection cups with expiration dates of 04/2022 (3) and 06/2022 (6) Three (3) Sterile Collection Swabs with expiration date of 06/01/2023 Two (2) Boric Acid Vacutainers with expiration date of 01/31/2023 Three (3) Hema-screen tests (used to test for hidden blood in stool samples) with expiration date of 06/30/2023 Twenty-Seven (27) Yellow Specimen Sterile Cups with expiration date of 02/28/2025 Observations in the storage closet on 04/28/2025 at 12:48 PM revealed the following expired supplies: One-thousand forty (1,040) Tempa-Dot (single use thermometer) with expiration date of 03/13/2025 One-thousand two hundred (1,200) Cotton Tipped Applicators with expiration date of 12/07/2024 Two Hundred (200) Cotton Tipped Applicators with expiration date of 12/12/2024 Eighty-Four (84) rolls of surgical tape with expiration date of 09/08/2024 Fifty (50) Transparent Dressing with expiration date of 10/2024 Thirty-One (31) rolls of self-adherent wrap with expiration date of 10/2024 Observations on the treatment floor on 04/28/2025 at 10:43 AM revealed 1 of 1 crash cart unlocked and accessible to staff and patients. 3. During an interview on 04/28/2025 at 10:10 AM, the CM verified the above expired supplies on the treatment floor. During an interview on 04/28/2025 at 10:50 AM, the CM verified the above expired supplies in the crash cart and Emergency Box. During an interview on 04/28/2025 at 12:38 PM, the ATOM and Biomed verified the above expired supplies in the back storage room. During an interview on 04/28/2025 at 1:08 PM, the Biomed verified the above expired supplies in the storage closet. During an interview on 04/29/2025 at 3:53 PM, the CM stated that the crash cart should be locked at all times and that all medications and supplies should be discarded on or before their expiration dates.”