Summary:
Summary Statement of Deficiencies D0000 An announced initial CLIA certification survey conducted at The Dermatology Group of Florida on 5/30/2019. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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. This STANDARD is not met as evidenced by: Based on review of patient reports and interview with Office Manager (OM) the laboratory failed to include the location and the correct laboratory name in final patient reports. Findings include: Review of final patient reports: KW19-018 (1/4 /2019) KW19-058 (2/7/2019) KW19-108 (3/14/2019) KW19-180 (4/4/2019) Revealed that the reports missed to include the laboratory address and used as laboratory name Pruett Dermatology instead of The Dermatology Group of Florida. During an interview on 05/30/19 at 11:00 a.m., the OM confirmed that the final report did not include the correct laboratory name and address. 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 --