Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, chart notes, Mohs map, slides, and interview, the laboratory failed to correctly label a slide used in Mohs for one of 10 cases reviewed. Findings follow. A. Review of the laboratory's policy and procedure titled Histopathology - Mohs Surgery, reviewed 01/12/2023, at 3.4.9 stated, " Slides are labeled with date, patient first, initial, and last name, location, stage number (Roman numeral), & Section number (Arabic numeral)." B. Review of the chart notes for 10 cases showed one patient, DOB 03/06/1952, tested on 01/03/2022 had the following Mohs Stages and number of sections: # of Sections Stage 1 2 Stage 2 1 Stage 3 1. C. Review of the Mohs map showed sections 1 & 2 for Stage I, 3 for Stage II, and 4 for Stage III. D. Review of the slides revealed the slides were labeled as the following: I-1 I-2 II-3 II-4. E. Interview with the histotechnician on November 2, 2023, at 1630 hours in the breakroom acknowledged the fourth slide was mislabeled as Stage II and should be Stage III. 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 --