Ameripath Lubbock 501(A)

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. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observations, review of the CMS (Center for Medicare and Medicaid Services) 116 form, and confirmed in staff interview, the laboratory failed to ensure two of two tissue marking stains did not exceed their expiration dates. Findings included: 1. During a tour of the histopathology laboratory on 12/04/2024 at 10:54 a.m., the surveyor observed the following expired tissue marking stains located on the counter next to the microscope: Tissue Marking Dye - Green; lot #9253; Expiration date: 09/30/2021 Tissue Marking Dye - Black; lot #9254; Expiration date: 09/30/2021 2. Based on review of the CMS 116 form submitted on the date of the survey, the laboratory performed 17 histopathology frozen sections annually. 3. During an interview 12/04/2024 at 10:56 a.m. in the laboratory, the Quality Assurance Coordinator confirmed the tissue marking stains had exceeded their expiration date. 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 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 04/02 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 04/02 /2021. The laboratory was found to be in substantial compliance for the specialties /subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory's policy, Frozen Section Log, patient test reports and confirmed in interview, the laboratory failed to test and document the intended reactivity of toluidine blue stain for frozen section slides each day of use for 1 of 15 days in 2020 and 1 of 8 days in 2021. Findings: 1. Review of the laboratory's policy "Frozen Section Procedure" revealed: "6. PROCEDURE ... 3. Steps ... Document the acceptability of the stain quality on the Frozen Section Log. Toluidine Blue Stain Quality acceptability criteria: Nuclei Stain Blue With Crisp Clear Morphology; Polysaccharides are Purple." 2. Review of the laboratory's "Frozen Section Log" did not include for each day of use, documentation of the intended reactivity for the toluidine blue stain on the following days patients were tested and reported in 2020 and 2021: 12/04/2020 Patient ID: HS20-11928 01/22/2021 Patient ID: HS21-665 3. 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 -- During an interview on 04/02/2021 at 12:15 pm, the QA Coordinators confirmed the above findings. -- 2 of 2 --