Summary:
Summary Statement of Deficiencies 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 record review and interview with testing personnel #1 (TP1), the laboratory failed to include the specimen case number for its histopathology testing for one (patient #1) of seven patient test reports reviewed. Findings include: 1. A review of the test reports for patient #1 revealed the patient had histopathology testing performed 4/11/24 on two sites, nasal supratip and left nasal ala, using the same case number with "A" and "B" differentiating between the two sites. A review of the test report, including the mohs map and the surgical note, revealed a lack of case number for the second site, left nasal ala. 2. A review of the laboratory's "Test Procedure" revealed a section titled "MOHS CASE MAP" stating, "The histotech is responsible for filling out the following information on the top of the "Mohs Case Map" form: the accession number and his/her initials." 3. An interview on 8/4/25 at 10:05 am with TP1 confirmed the lack of case number on patient #1's test report. 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 --