Summary:
Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e)(4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the DTM (Dermatophyte Test Medium) QC (Quality Control) log, the Throat Culture patient log, and an interview with the Laboratory Employee, the laboratory failed to document media QC performance and results, media lot numbers, and expiration dates for each lot number prior to use for patient testing. This was noted for 11 of 11 months reviewed in 2024 through 2025. The findings include: 1. A review of the DTM QC log revealed no documentation of media and expiration date after Lot# D-1465-0622 was put into use 9/6/22 and expired 6/27/24. 2. A review of the patient log revealed the last patient was performed on 5/19/2025 before the media went on back order. 3. During an interview on 10/14/2025 at 10:15 PM, the Laboratory Employee confirmed media documentation was missed. 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 --