Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Delray Dermatology LLC on April 13, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited is as follows: D5805 TEST REPORT CFR(s): 493.1291(c) (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. This STANDARD is not met as evidenced by: Based on review of patients' pathology reports and interview, the laboratory failed to list the correct name and address of the laboratory where the technical component was performed for three (Patients #1- #3) of six (Patients #1- #6) patients' reports reviewed, and failed to list the correct name for three (Patients #3- #6) of six (Patients #1- #6) patients' reports reviewed. Findings Included: 1. Review of the pathology reports revealed the name and address of the laboratory where the technical component was performed for three reports (Patients #1 - #3), and the name of the laboratory where the technical component was performed for three reports (Patients #3 - #6) were not as it appeared on the Center for Medicare and Medicaid Services website. 2. During an interview on 04/13/26 at 3:30 PM, the Histology Technician revealed the name and address was incorrect on three reports, and that the address was corrected on the three other reports, but the name of the laboratory listed on those reports was not corrected. 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 --