Radiant Complexions

Summary Statement of 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. This STANDARD is not met as evidenced by: Based on review of patient test reports and confirmed by interview with the Mohs technician, the laboratory failed to retain the Mohs map for one out of five patients who had Mohs surgery performed between 6/24/2024 and 9/23/2024. The findings include: 1. On 6/24/2024 the laboratory performed Mohs surgery on patient identifier A. 2. The laboratory failed to attach the Mohs map for patient identifier A in the electronic medical record. 3. The Mohs technician stated that laboratory would scan a copy of the Mohs map into the electronic health records and then keep the original Mohs map for two months before shredding. 4. At the time of the survey, the histology technician confirmed that the laboratory failed to retain the Mohs map for patient identifier A. 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 D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (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 review of laboratory procedures and patient test reports, lack of cryostat temperature logs, and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 4/18/2023, the laboratory failed to document cryostat temperatures for one out of one day of records reviewed in February 2023. The findings include: 1. The Mohs procedure states that the cryostat must be at a minimum of -20 degree Celcius to cut tissues for Mohs specimens. 2. On 2/27/2023, the laboratory performed Mohs testing on two patients. 3. At the time of the survey, the laboratory did not have documentation of the cryostat temperature for the specimens cut on 2/27/2023. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. 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 -- This STANDARD is not met as evidenced by: Based on lack of quality control records, review of patient test reports, and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 1:30 pm on 4/18/2023, the laboratory failed to document the Hematoxylin and Eosin (H&E) stain quality each day of patient testing for one out of one day of records reviewed in February 2023. The findings include: 1. On 2/27/2023 the laboratory performed Mohs testing on 2 patients. 2. At the time of the survey, the laboratory did not have documentation of H&E stain quality from 2/27/2023. -- 2 of 2 --