Fresenius Medical Care Midwest Waukesha

“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: 30177 Based on observation, interview, and review of the facility’s policy, the facility failed to implement measures to identify and remove expired supplies from active inventory. This failure allowed expired supplies to remain accessible for patient use and did not ensure their efficacy and safety. This failure had the potential to lead to the administration, use, and receipt of expired medical supplies, which could compromise patient safety. This failure had the potential to negatively affect the 34 in-center hemodialysis patients receiving care in this facility. Findings include: Observation of the facility’s “Emergency Medical Cart” on 07/24/24 at 2:15 PM revealed the following: Two of two 50% Dextrose Injection 25 gram/50 milliliter- Manufacturer’s expiration date 08/01/22. BD Vacutainer Safety Lock Blood Collection Set 2 of 2 (23Gx3/4” x12”) Manufacturer’s expiration date 05/31/20 25 Luer Loc Cap Set Manufacturer’s expiration date 05/14/23 Blue Vacutainer Manufacturer’s expiration date 08/31/20 Green Vacutainer 21 Gx1-1/4 0.8x32 mm Manufacturer’s expiration date 09/30/22 14 Arteriovenous needles with clamp 15-gauge Manufacturer’s expiration date 02/26/23 Three of three Nasal Cannula Manufacturer’s expiration date 10/2020 Observation of the facility’s “Isolation Room” on 07/24/24 at 2:30 PM, which is currently used for non-hepatitis B patients, revealed the following: One box of Povidone-Iodine prep pads Manufacturer’s expiration date 06/2022 One box of single pack 48 Chlora Prep 2% chlorhexidine gluconate single swab stick applicators Manufacturer’s expiration date 08/2021 2x2 sterile sponge Manufacturer’s expiration date 05/2025 Two of two povidone-iodine swab stick cotton applicator Manufacturer’s expiration date 10/2022 Four of four Crit-line blood chamber Manufacturer’s expiration date 10/31/23 One box of 250 single-use Tempa dot thermometers for oral use. Manufacturer’s expiration date 06/12/22 Observation of the facility’s “Laboratory” Room on 07/24/24 at 2:45 PM revealed the following: 10 Clear top 3.0 mL vacutainer blood collection tube Manufacturer’s expiration date 06/30/22 30 Gold top 3.5 mL vacutainer blood collection tube Manufacturer’s expiration date 10/31/23 50 Blue top 2.7 mL vacutainer blood collection tube Manufacturer’s expiration date 10/31/22 Observation of the facility’s “Treatment” Area on 07/24/24 at 3:05 PM revealed the following: One bottle of 14 millisiemens per centimeter (mS/cm) conductivity solution with a Manufacturer’s expiration date observed as 02/11/24. Manufacturer’s instruction. One bottle of 10.00 potential of hydrogen (pH) buffer solution with a Manufacturer’s expiration date noted as 05/09/24. One bottle of 7.00 pH buffer solution with a Manufacturer’s expiration date was indicated as 02/12/24. One bottle of 4.00 pH buffer solution with a Manufacturer’s expiration date was noted as 04/28/24. During an interview on 07/24/24 at 3:30 PM, the Clinical Coordinator stated all supplies should have been disposed of when expired and revealed that nurses are required to check the emergency cart monthly and remove expired supplies. During an interview on 07/25/24 at 9:30 AM, the Director of Operations stated the expired supplies should have been disposed of during the monthly checks. A review of the facility’s policy titled “Expiration Dates Policy,” published on 07/04/2012, indicated, “ ...Items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date.””