Summary:
Summary Statement of Deficiencies D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview with the facility personnel, the laboratory failed to have one pathology report signed by the individual who performed the examination and made the diagnosis. Findings include: 1. The laboratory performs patient testing under the sub-specialty of Histopathology, with an approximate annual test volume of 2,100. The laboratory performs the Mohs procedure on patient specimens. It is the practice of the laboratory to record the Mohs test results on a Mohs Map and a Mohs Surgery Report Form. 2. Review of the Mohs test report forms for patient S994-2018 on 09/06/2018 failed to include the signature of the individual making the diagnosis. 3. The facility personnel confirmed that the pathology report indicated above was not signed by the individual who performed the examination and made the diagnosis. 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 --