Pathology Assocs Of North Texas Pa

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey on 1/17/2025. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Review of the laboratory provided test menu, laboratory policy, laboratory documentation, and confirmed in interview, the laboratory failed to follow their policy for the monitoring of contamination on the panther system performing molecular testing for one of two years reviewed in 2023 and 2024. The findings included: 1. Review of the laboratory provided test menu included the following molecular tests performed on the Panther System: CT/GC Trichomonas HPV HPV Genotype 18/45 2. Review of the laboratory policy titled "Contamination Monitoring Protocol For The Panther System", included the following instruction: "To monitor for laboratory contamination, the following procedure may be performed using the APTIMA Unisex Swab Collection kit for Endocervical and Male Urethral Swab Specimens: 1. Label swab transport tubes with number corresponding to the areas to be tested. 2. Remove the specimen collection swab (blue shaft swab with green printing) from its packaging, wet the swab in the swab transport medium, and swab the designated area using a circular motion. 3. Immediately insert the swab into the transport tube. 4. Carefully break the swab shaft at the score line: use care to avoid splashing of the contents. 5. Recap the swab transport tube tightly. 6. Repeat Steps 2 to 5 for each area to be swabbed. 7. Test samples with the APTIMA Trichomonas vaginalis Assay and /pr CT/GC Combo Assay on the Panther System. 8. Further investigation should be 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 -- performed if any samples yield a positive result. 9. For additional PATHER System- specific contamination monitoring information, contact Gen-Probe Technical Support. 10. Monitoring should take place at least every six months. Interpretation: Results should be Negative." Surveyor asked how often the laboratory performed the contamination checks, and testing personnel (TP) 10 stated they performed the test every six months, typically in April and October. 3. Review of the contamination check records for 2024 included the following six areas in the laboratory and preparation areas swabbed for contamination checks: Vortex Phone Light Switch Pipette Door Handle MTU Drawer Surveyor asked for the 2023 documentation, and none could be provided. 4. In an interview on 1/17/2025 at 11:26 in the reception area, TP 10 stated the laboratory failed to perform the contamination check for the Panther System in 2023 as the laboratory policy required. KEY: CT/GC - Chlamydia, Gonorrhea HPV - Human Papilloma Virus D5617 CYTOLOGY CFR(s): 493.1274(b)(2) (b)(2) Effective measures to prevent cross-contamination between gynecologic and nongynecologic specimens during the staining process must be used. This STANDARD is not met as evidenced by: Based on review of laboratory policy, laboratory annual statistics, and confirmed in interview, the laboratory failed to ensure effective measure to prevent cross- contamination between gynecologic and nongynecological specimens during the staining process were followed for documentation reviewed in 2023 and 2024 for a total of 18,301 cytology specimens processed. The findings included: 1. Review of the laboratory policy binder titled "Pathology Associates Quality Manual", subsection "Cross Contamination Control" stated the following: "Samples with a high potential for cross-contamination must be stained separately from all other specimens. Non-gyn and FNA specimens are stained in separately from Pap smears at the end of the day. Since we have a single staining setup solutions should be changed between gynecological and non-gynecologic specimens." 2. Review of the laboratory annual statistics for 2020 and 2024 included the following information: 2023 Cytology Annual Report Total Number Cytology Cases Examined 9374 Non-Gynocologic Cases - 332 Fine Needle Aspiration - 342 Gynecologic Cases - 8700 2024 Cytology Annual Report Total Number Cytology Cases Examined 8927 Non-Gynecologic Cases - 431 Fine Needle Aspiration - 302 Gynecologic Cases - 8194 3. Surveyor asked for documentation in the changing of stains after non gynecologic specimens to prevent the potential cross contamination to gynecologic specimens and none could be provided. 4. In an interview on 1/17/2024 at 11:45 hours, in the reception room, testing personnel (TP) 10 confirmed that the laboratory did not change stains between non-gynecological specimens and gynecological specimens. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties /subspecialties surveyed for 42 C.F.R 493.1459 Laboratories performing high complexity testing; general supervisor 493.1487 Laboratories performing high complexity testing; testing personnel Note: The CMS 2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Observations, review of the manufacturer's instructions for use and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions for storing patient specimens after testing using the Aptima Assays for Trichomonas, HPV and Combo 2. The findings included: 1. Observations made during the inspection found 10 test tube racks filled with previously tested specimens in the refrigerator. 2. Review of the Aptima manufacturer's instructions Trichomonas, HPV and Combo 2 Assays found under the heading Specimen Collection and Storage: " Specimen storage after testing: 1. Specimens that have been assayed must be stored upright in a rack. 2. The specimen transport tubes should be covered with a new, clean plastic film or foil barrier." 3. Interview of testing personnel conducted on June 13, 2019 at 10:59 AM confirmed that the laboratory stored patient specimens previously tested for the Aptima Assays for Trichomonas, HPV and Combo 2 in the refrigerator for 30 days without covering with a new barrier. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. 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 -- This STANDARD is not met as evidenced by: Review of the CMS Form-209 Laboratory Personnel Report, policies and procedures, cytotechnologists workload records from 2017 and 2018, and interview of facility personnel found that the laboratory failed to reassess individual workload limits at least every 6 months for all testing personnel involved in cytology testing. The findings included: 1. Review of the CMS Form-209 Laboratory Personnel Report found the Laboratory Listed 2 Cytotechnologists as performing Anatomic Pathology procedures. 2. Review of policies and procedures revealed that the laboratory had established procedures for reassessing workload limits at least every 6 months. 3. Review of 2017 and 2018 six-month workload records for cytologist one (as listed on Form CMS-209) revealed that her workload had been evaluated as follows: January 3, 2017 July 6, 2017 February 21, 2018 There was no second (6-month) evaluation of workload for 2018 available for review. 4. Review of 2017 six-month workload records for cytologist two (as listed on Form CMS-209) revealed that his workload had been evaluated as follows: January 3, 2017 There was no second (6-month) evaluation of workload for 2017 available for review. 5. Interview of general supervisor two (as listed on Form CMS-209) conducted on June 13, 2019 at 11:15 hours confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --