Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on 1/22/2026 and a standard level deficiency was cited. 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 review of control log sheets, client log sheets, and interview with the testing person, the laboratory failed to ensure positive control for wet mount quality control (QC) was not expired for 14 of 41 days in 2025. Findings included: 1. Review of wet mount control log sheets from 3/2025 through 5/2025 included expired positive control QC in 4/2025, lot number 1784, expiration date "03/03/25" (note: 3/2025 QC was not expired). The laboratory used the QC past the expiration date for 14 days in 4 /2025: 4/3/2025 - 4/6/2025, 4/11/2025 - 4/13/2025, 4/18/2025 - 4/21/2025, 4/25/2025 - 4/27/2025. 2. Review of the "CLIENT LOG SHEETS" with patient wet mount results from 4/2025 included 11 patients. 3. During an interview on 1/22/2026 at 11: 45 am, the testing person stated the QC expiration date was most likely a typo. 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 --