Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of an initial survey completed on June 10, 2026 and certification is recommended. Standard level deficiencies were cited. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory quality control documentation, laboratory patient records, and confirmed in interview, the laboratory failed to ensure documentation of intended stain reactivity to ensure predictable staining characteristics for hematoxylin and eosin, six out of six patients with slides stained for MOHS surgical procedures on December 6, 2025. The findings include: 1. Review of the laboratory procedure titled "MOHS Frozen Section Hematoxylin and Eosin Staining & Coverslipping Using Thermo Linstainer", section "Quality Control", included the following instructions: "To check stain quality and contrast prior to the staining of patient prepared slides, a designated control tissue slide will be made and stained before any other slides are stained. Control slide results will be documented daily." 2. Review of the laboratory document titled "Quality Control Analysis Log Sheet for H&E Staining Procedure" did not include control documentation for 12/8 /2025. 3. Review of the patient daily log included the following six patients with slides made and stained for the assessment of MOHS surgical procedures on 12/8 /2025: Patient ID: M202547 M202548 M202549 M202550 M202551 M202552 4. During the exit conference on 6/10/2026, at 10:55 hours, in the laboratory, the laboratory director confirmed that QC hadn't been documented on 12/8/2025. 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 -- D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory patient slides, MOHS maps, and patient final reports, the laboratory failed to ensure the MOHS accession number for positive patient identification was included on the patient final report for one of six random patients reviewed from September 2025 through March 2026. The findings include : 1. Review of the laboratory policy titled "Patient Specimen Labeling, Storage and Discard" included the following information: "1. A laboratory reference number for the Mohs surgicalflowsheets will be assigned. All slides and specimen holders must be labeled before processing and must contain sufficient information to uniquely identify the patient specimen throughout testing. See below examples: 2025- *** = year date, and accession number given to that patient and surgical specimen. This specific accession number will link the flowsheet, report, and slides. Patient identification will be verified using at least two patient identifiers prior to specimen processing." 2. Review of the following patient slides, Mohs surgicalflowsheets included the following accession number for procedures performed on 3/24/2026: M2026191 [Patients Last name, first initial] Review of the patient's final report for Mohs procedures performed on 3/24/2026, included the following Mohs Case Number: 2026-141. 3. In an interview on 6/10/2026 at 10:35 hours, in the laboratory, the office manager confirmed the accession number on the patient final report had been documented incorrectly. -- 2 of 2 --