Delta Pathology Group, Llc - Women's & Children's

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Delta Pathology Group, LLC-Women's & Children's, CLIA ID 19D2014889, on July 10, 2026. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of maintenance records, frozen section patient reports, and interview with personnel, the laboratory failed to ensure the cryostat disinfection maintenance procedures were performed each day of use per the laboratory's policy for one (1) of one (1) day reviewed. Findings: 1. Review of the laboratory's "Cryostat Cleaning Disinfection/Fumigation & Maintenance Log Cryostat Model: Tissue Tek Cryo3" revealed "using Cryostat Disinfection Cycle Each Day of Use." 2. Further review of the laboratory's "Cryostat Cleaning Disinfection/Fumigation & Maintenance Log" and frozen section patient report revealed the cryostat was used June 22, 2026. The cryostat disinfection cycle was not performed June 22, 2026. 3. In interview on July 10, 2026 at 1:20 pm, the Director of AP stated the identified disinfection procedure should have been performed on June 22, 2026. The Director of AP confirmed the laboratory did not perform the identified task. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) 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 -- (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure maintenance procedures were followed to ensure acceptable levels of test performance. Refer to D5433. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An Initial certification survey was performed on February 10, 2025 at Delta Pathology Group, LLC Women's & Children's, CLIA ID #19D2014889. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)