Genova Diagnostics

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation 4/29/26, review of the MICRO (AVL) 100.7 Media Quality Control policy, and interview with the microbiology TS (Technical Supervisor) on 4 /30/26, the laboratory failed to discard expired media. Findings: 1. During a tour of the laboratory at approximately 3:00 p.m. on 4/29/26, the surveyor observed 2 open boxes of expired Corn Meal Agar in the microbiology walk-in refrigerator number D6547 available for use, including: a. 1 box labeled REF 5339 Lot 2510002M Expiration 4/3/26, marked opened for QC 1/27/26, containing 1 package with 5 plates. b. 1 box labeled REF 5339 Lot 2510002M Expiration 4/3/26, marked opened 2/4/26, containing 4 packages with 10 plates each. 2. Review of the MICRO (AVL) 100.7 Media Quality Control policy revealed the quality control process for Corn Meal Agar. Page 2 of the policy stated, "If the media performs as expected, record the lot number, date received, expiration date, .... on the QC ordered in Total QC." The policy also stated, "Records will be reviewed monthly." The policy did not include instructions for the disposal of expired supplies. 3. During an interview at approximately 9:30 a.m. on 4/30/26, the TS stated expired supplies should be discarded and the supervisor should be notified if stock is low. The TS stated that expirations are checked during monthly inventory counts at the end of the month and the short dates are mentioned during huddles. At approximately 10:20 a.m., the TS confirmed there was no policy that specifically addressed discarding expired supplies. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based upon review of the iCAP Q ICP-MS Operating Manual, review of 2023 and 2024 maintenance logs and interview with TS (technical supervisor) #5 on 5/15/24, the laboratory failed to perform and document maintenance tasks required by the manufacturer of the ICP-MS instrument. Findings: Review of the iCAP Q ICP-MS Operating Manual revealed the following in Chapter 8: Maintenance: Table 8.1: 1. Item: Mass Analyzer Air Filter, Procedure: Check fan, Frequency: Monthly 2. Item: Sogevac Fore Vacuum Pump, Procedure: Check oil, Frequency: Daily 3. Item: Sogevac Fore Vacuum Pump, Procedure: Check gas ballast valve, Frequency: Monthly Review of 2023 and 2024 maintenance logs for the ICP-MS instrument did not reveal documentation of the performance of the following maintenance tasks: 1. Monthly fan check of mass analyzer air filter 2. Daily oil check of Sogevac Fore vacuum pump 3. Monthly gas ballast valve check of Sogevac Fore vacuum pump During interview at approximately 11:20 a.m. on 5/15/24, TS #5 stated in a Teams chat that the aforementioned maintenance tasks are performed; however, they are not documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --