Smart Skin Dermatology

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 direct observation and interview with the Office Manager, the laboratory failed to ensure that the staining reagents were not used past the expiration date. The laboratory performs approximately 144 histopathology tests annually. Findings Include: 1. Direct observation of reagents revealed the Acetone, lot number 152630, had an expiration date of 2024-05-31, Eosin-Y Vintage, lot number 183089, had an expiration date of 2025-04-30, Gill 3 Hematoxylin, lot number 151413, had an expiration date of 2023-12-31, Eosin-Y Alcoholic 0.25%, lot number 149182, had an expiation date of 2024-05-31, and 100% Reagent Alcohol, lot number 152460, had an expiration date of 2024-06-30 at 12:55 PM on 06/12/2025. 2. Interview with the Office Manger at 12:55 PM on 06/12/2025 confirmed the staining reagents were used for patient testing past the expiration date. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the laboratory Standard Operating Procedure (SOP) manual and an interview with the Clinical Operations Manager (COM), the laboratory had failed to establish written policies and procedures to assess employee competency for Hematoxylin and Eosin (H&E) slide reading and Potassium Hydroxide (KOH) testing during 2022. Findings include: 1. A review of the SOP manual at 10:30 AM on 8/21 /23 revealed that the laboratory had failed to establish written policies and procedures to assess employee competency for H&E and KOH testing. 2. An interview with the COM at 11:00 AM on 8/21/23 confirmed that the laboratory had failed to establish written policies and procedures to assess employee competency for H&E and KOH testing. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory Standard Operating Procedure (SOP) manual and 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 -- an interview with the Clinical Operations Manager (COM), the laboratory had failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements (Quality Assurance Policy). Findings include: 1. A review of the SOP manual at 10:30 AM on 8/21/23 revealed that the laboratory had failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements. 2. An interview with the COM at 11:00 AM on 8/21/23 confirmed that the laboratory had failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory Standard Operating Procedure (SOP) manual and an interview with the Clinical Operations Manager (COM), the laboratory had failed to establish a written procedures manual for Hematoxylin and Eosin (H&E) slide preparation and staining, and Potassium Hydroxide (KOH) testing. The laboratory performs 144 H&E tests and 6 KOH tests annually. Findings include: 1. A review of the SOP manual at 10:00 AM on 8/21/23 revealed that the laboratory had failed to establish a written procedures manual for H&E slide preparation and staining, and KOH testing. 2. An interview with the COM at 11:00 AM on 8/21/23 confirmed that the laboratory had failed to establish a written procedures manual for H&E slide preparation and staining, and KOH testing. -- 2 of 2 --