Summary:
Summary Statement of 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's final reports and interview with the laboratory director, the laboratory did not ensure that the final test report listed the name of the laboratory as it appears on the CLIA certificate. Findings: 1. The CLIA certificate lists the name of the laboratory as "Leonard C. Sperling, MD." 2. The final patient reports in the computer system lists the name of the laboratory as "HCT Dermatopathology Services, Potomac Maryland Annex." 3. During the exit interview on 07/29/19 at 12: 30 PM the laboratory director confirmed that the final reports in the computer system did not list the name of the laboratory that was on the CLIA certificate. 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 --