Fresenius Kidney Care Ypsilanti

“MD RESP-DEVELOP, REVIEW & APPROVE P&P CFR(s): 494.150(c)(1) The medical director must- (1) Participate in the development, periodic review and approval of a “patient care policies and procedures manual” for the facility; This Standard is not met as evidenced by: 50585 Based on observation and interview, the medical director failed to ensure policies and procedures were developed for calibrating thermometers for the laboratory refrigerator for 1 of 1 laboratory refrigerators. Findings include: On 10/1/2024 at 1045, during a tour of the patient treatment area with Facility Administrator Staff A, the thermometer connected to the laboratory reagent refrigerator in the laboratory area was observed to have a label that revealed a calibration due date of 7/14/2019. Staff A confirmed the finding and when interviewed at the time of discovery, Staff A revealed that they had “no idea what it means.” On 10/2/2024 at 1120, Staff A was interviewed and they revealed that the facility does not have a policy on calibrating thermometers for the laboratory refrigerator. On 10/2/2024 at 1350, Medical Director Staff N was interviewed and when queried if they expected the laboratory refrigerator thermometer to be calibrated according to manufacturer’s recommendations, they said “yes.””

“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: 47415 Based on observation, interview, and record review, the medical director failed to ensure staff follow facility policy regarding removing expired medications and supplies resulting in the potential for less-than-optimal outcomes to all patients served by the facility. Findings include: On 10/1/24, during initial tour of the treatment floor, the medication storage area was observed, and the following expired medications were found: At 1120, 14 full bottles and one open bottle of expired Calcitriol 0.25 microgram (mcg) capsules found in medication storage drawer #3. (1 bottle expired May 2024 and 14 bottles expired August 2024). At 1124, 1 Pneumococcal 13-valent conjugate vaccine (single dose) found expired in the medication refrigerator, expired September 2024. On 10/1/24 at 1130, Facility Administrator Staff A confirmed the Calcitriol and pneumococcal vaccines were expired. On 10/2/24 at 0900, the crash cart was observed. The crash cart was opened and 1- one-liter intravenous bag of 0.9% Sodium Chloride was found that expired in October 2023. At the time observation, RN Staff L confirmed the expired intravenous bag found in the crash cart. On 10/2/24 record review of facility policy (47488) titled, “Medication Preparation and Administration”, dated 2/3/23, revealed: “Expiration dates for all stored medications are to be monitored on a monthly basis ... Expired medications are to be discarded via...off-site return program or in accordance with local and/or state law ... CDC immunization program states vaccine are to be discarded per manufacturer’s expiration date.” On 10/2/24 at 1356 a phone interview with the Medical Director Staff N revealed that it was her expectation that staff follow policies and procedures of the facility. 50585 On 10/1/2024 during an initial tour of the patient treatment area with Facility Administrator Staff A, the following supplies were observed stocked in supply storage areas and were expired: 29 blood collection tubes containing Boric Acid with expiration date 8/31/2024 1 purple blood collection tube with expiration date 3/31/2023 1 purple blood collection tube with expiration date 2/29/2023 2 blood collection tubes with expiration date 4/14/2023 2 seventeen gauge, one inch fistula needles with expiration date 8/10/2024 6 seventeen gauge, one inch fistula needles with expiration date 3/30/2024 90 eighteen gauge hypodermic needles with expiration date 7/31/2024 Staff A confirmed the findings at the time of discovery. On 10/2/2024 at 0900, during a review of the contents of the code cart with Nurse Staff L, 16 laboratory needles with an expiration date 5/31/2024 were observed stocked in the code cart drawer. Staff L confirmed the findings at the time of discovery. Upon review of the facility’s policy “Expiration Dates Sterile Supplies,” dated 2020, the policy revealed that “Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date.””