Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observations, review of the Safety Data Sheets (SDS), reagent manufacturer's storage requirements, Standard Operating Procedures (SOPs), as well as interview with the Practice Manager (PM), the laboratory failed to comply with manufacturer's instructions for conditions that are essential for proper storage of reagents. FINDINGS: 1. The surveyor observed in the Mohs processing laboratory on January 15, 2026, at approximately 1:15 P.M., the following reagents and processing materials were not properly stored in a flammable materials storage cabinet as required by the SDS and the reagent manufacturer's storage requirements: a. Ricca Eosin Y Stain, 0.25% (w/v) in 57% (v/v) alcohol, Acidified Working Solution, lot: 25111336, expiration: November 2027, one unit was retained on a plastic shelf in the storage closet within the Mohs processing laboratory. b. Epredia Shandon - Mount, 120 mL, lot: 139896, expiration: March 5, 2026, one unit was located on the counter in the Mohs processing laboratory, one unit was retained on a plastic shelf in the storage closet within the Mohs processing laboratory. c. National Diagnostics Histoclear Histological Clearing Agent, lot: 01-22-20, expiration: January 2027, received: December 17, 2023, one gallon unit was retained on a plastic shelf in the storage closet within the Mohs processing laboratory. d. Mercedes Scientific 95% 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 -- Reagent Alcohol, lot: 2521201, expiration: July 31, 2028, received: September 24, 2025, six one-gallon units were retained on a plastic shelf in the storage closet within the Mohs processing laboratory. e. Mercedes Scientific 100% Reagent Alcohol, lot: 2524121, expiration: March 9, 2028, received: September 24, 2025, eight one-gallon units were retained on a plastic shelf in the storage closet within the Mohs processing laboratory. 2. This was contrary to instructions in the current, approved Chemical Hygiene Plan, Chemical Storage SOP, that stated flammable liquids were to be stored in flammable storage cabinets with self-closing doors in accordance with National Fire Protection Association (NFPA) standards. 3. The PM confirmed the findings on January 15, 2026, at approximately 4:00 P.M. -- 2 of 2 --