Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at LUMINARY DERMATOLOGY OF MIAMI LLC from September 9, 2025 to September 26, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to retain daily maintenance records for Histology laboratory for one out of four months reviewed in 2024 (April and November) and in 2025 (February and July). Findings included: 1- Review of Luminary Dermatology Daily QC and Maintenance log were missing for Cryostat Micron HM525, room temperature and humidity, Linistat linear stainer Hematoxylin and Eosin, Olympus CH microscope for April 2024. 2-Review of Mohs surgery log revealed 14 patients were tested 04/12/2024. 3-During a phone interview on 09/19/2025 at 3:25 PM with Risk Management consultant, stated that the records were not found since the laboratory was previously managed by another group. 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 --