Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 laboratory policy, patient test records, and confirmed in interview, the laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers for 23 of 23 slides reviewed in 2024 (August through October). Findings included: 1. Review of the laboratory policy titled "Policy for lableing [sic] Slides" stated: "Each slide should be labeled with Patient's last name, first name (or initial), case accession number, stage number, section number, slide count in alphabetical order, and the date. (Example) Last name, First name 22-0001 I1A 09/01/22" The laboratory policy did NOT include labeling instructions to reliably identify patients using at least two unique patient identifiers to distinguish between specimens. 2. A review of patient slides from 2024 (August through October) revealed: 08/22/2024: 8 slides were labeled with patient last name and first initial, Mohs accession number, stage number, section number, slide count in alphabetical order, and the date. The Mohs accession numbers were as follows: 24M-0001, 24M- 0002. 09/26/2024: 7 slides were labeled with patient last name and first initial, Mohs accession number, stage number, section number, slide count in alphabetical order, and the date. The Mohs accession number was as follows: 24M-0003. 10/17/2024: 8 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- slides were labeled with patient last name and first initial, Mohs accession number, stage number, section number, slide count in alphabetical order, and the date. The Mohs accession number was as follows: 24M-0004. The laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least two unique patient identifiers. 3. During an interview on 11/07/2024 at 9:45 a.m., the Histotechnician after a review of the records, confirmed the above findings. -- 2 of 2 --