Summary:
Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on direct observations, review of the Material Safety Data Sheets (MSDS), reagent manufacturer's storage requirements, as well as interview with the Testing Person (TP), the laboratory failed to properly store flammable reagents in the Mohs processing laboratory as required by the MSDS. FINDINGS: 1. The surveyor's observations in the Mohs processing laboratory confirmed on December 2, 2025, at approximately 9:30 A.M., the following reagents and processing materials were not properly stored in the flammable materials storage cabinet as required by the MSDS and the manufacturer's storage requirements: a. Avantik Acetone, lot: 2426703, expiration: September 30, 2027, stored in a cabinet beneath the sink in the Mohs processing laboratory inside a purple "Pearson Prentice Hall" canvas bag. b. Avantik Eosin Working Solution, lot: 43090129, expiration September 19, 2025, stored in a cabinet beneath the sink in the Mohs processing laboratory inside a plastic bag. 2. The TP confirmed the findings on December 2, 2025, at approximately 12:00 P.M. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on direct observations, review of Standard Operating Procedures (SOPs), as well as interview with the TP, the laboratory failed to remove from inventory expired reagents, solutions, and testing supplies utilized for patient specimen processing. FINDINGS: 1. The surveyor's observations in the Mohs laboratory confirmed on December 2, 2025, at approximately 9:00 A.M., the following reagents and processing materials were not removed from inventory: a. Avantik Tissue Marking Dye Red, lot: 183621, expiration: October 31, 2025, stored under the fume hood in the Mohs processing laboratory. b. Avantik Eosin Working Solution, lot: 43090129, expiration: September 19, 2025, stored in the Justrite flammable liquid storage cabinet in the Mohs processing laboratory. c. Avantik Xylene, lot: AX011, expiration October 2019, stored in the Justrite flammable liquid storage cabinet in the Mohs processing laboratory. d. Avantik Xylene, lot: 2211911, expiration: May 4, 2025, stored in the Justrite flammable liquid storage cabinet in the Mohs processing laboratory. 2. This was contrary to instructions indicated in the current, approved SOPs for removal of expired reagents from inventory. 3. The TP stated the expired Avantik Tissue Marking Dye Red and expired Avantik Eosin Working Solution were utilized for patient specimen processing. Ninety-seven patient specimens were processed using the expired Avantik Tissue Marking Dye Red and 171 patient specimens were processed using the expired Avantik Eosin Working Solution. 4. The TP informed the surveyor that the expired Avantik Xylene was not utilized for patient specimen processing. 5. The TP confirmed the findings on December 2, 2025, at approximately 12:00 P.M. -- 2 of 2 --