Lauring Dermatology Llc

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 review of the "Tzanck Stain Log" and interview with office manager (OM), the laboratory failed to ensure that the expiration dates of the stains used were not used past the expiration date. Findings: 1. The "Tzanck Stain Log" records for 2023 and 2024 were reviewed to ensure documentation of the lot numbers (#) and expiration dates of the stains and solutions used during the staining process. 2. The "Tzanck Stain Log" records showed that the lot # was being recorded, but not the expiration date. 3. During the survey on 03/21/2024 at 10:15 AM, the OM confirmed that the records failed to include the expiration date of the fungal Tzanck stain that was used in the laboratory. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 review of final reports and interview with the office manager (OM), the laboratory failed to ensure that the final test report included the result of the Tzanck Stain (herpes simplex virus) result. Findings: 1. Two final test reports were reviewed in the laboratory' electronic medical record (EMR) system. One of the two test reports did not list the reactivity of the fungal Tzanck stain as positive or negative. 2. During the survey on 03/21/2024 at 10:15 AM, the OM confirmed that the EMR records failed to include the positive or negative reactivity of the fungal Tzanck stain on the final report. -- 2 of 2 --

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 testing logs and interview with the practice manager (PM), the laboratory failed to maintain the testing logs for at least two years. Findings: 1. The laboratory performed Tzanck smear testing. 2. A log titled "Fungal Tzanck Stain Log" was used to record the date of testing, the stain lot number and expiration date, the stain quality control results, and the patient results. 3. The log only had results from testing performed in 2022. 4. During the survey on 10/21/2022 at 10:00 AM, the PM confirmed that the log sheet for testing performed in 2021 had been removed and could not be located. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)