Lakes 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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure 2 of 4 Histopathology tissue marking materials were not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the subspecialty Histopathology as confirmed by the Histology Technician (HT) during a tour of the laboratory at 11:10 a.m. on 03/05/20. 2. Expired tissue marking materials were observed as present and available for use during the tour of the laboratory. See below. -Mercedes Medical Tissue Marking Dye, Blue Lot 7540 Expiration 04/18 -Mercedes Medical Tissue Marking Dye, Red Lot 7537 Expiration 04/18 3. In an interview at 10: 30 a.m. on 03/05/20, the HT confirmed the above finding. 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 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 observation, document review and interview with laboratory personnel, the laboratory failed to ensure a histopathology staining solution was not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery under the specialty of Histopathology as confirmed by Mohs Technician 1 (MT1) during a tour of the laboratory on 3/20/18 at 10:05 a.m. 2. One expired Stat Lab Hematoxylin staining solution jug was observed as present and available for use in the laboratory. Lot number = 48325 Expiration date = 2/1/2018 3. In an interview on 3/20/18 at 12:30 p.m., MT1 confirmed the expired Hematoxylin staining solution was available for use. 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 --