Summary:
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 surveyor review of laboratory records and interview with the acting regional manager (staff A), the laboratory used expired products for the Mohs slide staining process as follows: Reagent Alcohol and Hematoxylin stain for ten of ten cases occurring on May 22, 2025, and Hematoxylin stain for five of five cases on the next day of service, June 12, 2025. Findings include: 1. Review of Log 722-C, "Quality Control Assessment of Mohs Tissue Staining Procedure", showed the following reagents were in use: QC Date | Hematoxylin Lot#/Expiration Date | Reagent Alcohol Lot#/Expiration Date May 22, 2025 | 111323 / May 13, 2025 | BC1103XC / April 19, 2025 June 12, 2025 | 111323 / May 13, 2025 | BC0975XB / April 7, 2027 June 13, 2025 | 380154 / November 14, 2026 | BC0975XB / April 7, 2027 2. Review of the "Mohs Patient Log" showed ten Mohs cases on May 22, 2025, and five Mohs cases on June 12, 2025. 3. Interview with staff A on November 3, 2025, at 11:10 AM confirmed the laboratory used expired Reagent Alcohol and Hematoxylin stain for the Mohs cases on May 22, 2025, and expired Hematoxylin stain for the Mohs cases June 12, 2025. 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 --