Cosmetic & Procedural Dermatology

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 observation of Histopathology reagents and dyes, surveyor review of the Procedure Manual (PM) and interview with the Laboratory Director (LD), the laboratory failed to dispose expired Histopathology reagents and dyes from 1/31/22 to the date of survey. The findings include: 1. The Procedure Manual (PM) states "Expired reagent chemicals are not permitted for use during frozen section processing. Any reagent that has reached the expiration date must be properly discarded. No expired chemical reagent should ever be used or stored in the Moh's laboratory beyond the expiration date." 2. One Red Tissue Marking Dye 2 ounce container Lot # 093059 expired on 1/31/22. 3. The laboratory performed approximately 1300 Histopathology tests annually. 4. The LD confirmed on 10/24/23 at 11:00 am that the laboratory failed to dispose the expired Tissue Marking Dye. 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 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 surveyor review of the Leica Manufacturer's Manual, lack of a Temperature Log (TL) and interview with Testing Personnel (TP), the laboratory failed to follow the Manufacturers Instructions to monitor and document Room Temperature (RT) and Humidity where Histopathology tests were performed from 8/17/17 to the date of survey. The TP confirmed on 8/15/19 at 10:20 am that the laboratory did not follow the MI . 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 --