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 18 of 18 slides in 2022 (November random review) and 10 of 10 slides in 2023 (May random review). The findings include: 1. Review of the laboratory policy titled "Embedding, Cutting, and Cover-slipping Frozen Sections" revealed: "Procedure ... 2. The reverse slide mount method is used for embedding. Each slide will be labeled with the patient name, ,[sic] stage and piece number, slide number, and Mohs accession number. a. Mohs accession number is assigned by location and year (ex. MM22-001) b. Stages are Roman number: Examples: I, II, III, IV, V, etc c. Piece number is the number of piece(s) the surgeon divides the tissue into d. Slide number is an alphanumeric number: Examples: A- first slide, B- second slide, C- third slide, etc" An example of how to label a slide was illustrated in the policy: "Doe, J. MM22-001 1/1/22" The laboratory policy did not include labeling instructions to reliably identify patients using at least 2 unique patient identifiers to distinguish between specimens. 2. A random review of patient slides from 2022 (November) and 2023 (May) revealed 28 slides labeled with a patient last 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 -- name and first initial, Mohs accession number, piece number, slide number, and date of service. The laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers. 3. During an interview on 05/222 /2023 at 10:35 a.m., the Office Manager and Regional Clinical Manager confirmed the above findings. -- 2 of 2 --