Terrell Urgent Care

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES of the CLIA program: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing desk review of Centers for Medicare and Medicaid Services (CMS) 0155 report and American Proficiency Institute (API) 2024 and 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 3 -- proficiency testing (PT) records, the laboratory failed to successfully participate in the specialty of Hematology in the WBC Diff (White Blood Cell Differential) analyte for two of three events in 2024 and 2025, resulting in an initial PT failure. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155 Individual Laboratory Profile, American Proficiency Institute (API) proficiency testing (PT) records from 2024 and 2025, and confirmed in interview, the laboratory failed to achieve satisfactory performance (80% or greater) for the WBC Differential (WBC Diff) analyte in two out of three proficiency testing events in 2024 and 2025, resulting in an initial PT failure. Findings Included: 1. Review of the CASPER 0155 report revealed the following results: a. Hematology 2024-Third Event: Laboratory received an unsatisfactory score of 0% for WBC Diff analytes. b. Hematology 2025-First Event: Laboratory received an unsatisfactory score of 67% for WBC Diff analytes. 2. Review of the AAB Proficiency Testing records confirmed the laboratory received the above results for the WBC Diff analyte in two out of three proficiency testing events in 2024 and 2025. 3. In an interview in the facility break room on 09/24/2025 at 10:15 AM, the facility laboratory manager confirmed the laboratory failed to achieve satisfactory performance (80% or greater) for the WBC Differential (WBC Diff) analyte in two out of three proficiency testing events in 2024 and 2025, resulting in an initial PT failure. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of CMS 0155 report and American Proficiency Institute (API) 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS 0155 report and American -- 2 of 3 -- Proficiency Institute (API) 2024 and 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the WBC Diff (White Blood Cell Differential) analyte for two of three events in 2024 and 2025. Refer to D2130. -- 3 of 3 --

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 in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of laboratory SARS-Co-V-2 patient testing records, review of laboratory SARS-Co-V-2 result reporting records, and staff interview, it was revealed that the laboratory failed to report SARS-Co-V-2 positive and negative test results for 8 of 8 months reviewed (January 2021 - August 2021). Findings included: 1. Review of SARS-Co-V-2 patient tests records (Test performed using the Quidel Sofia SARS Antigen test kit and instrumentation) from 01/01/2021 through 08/31/2021 revealed 8,840 patients were tested for SARS-CoV-2. 2. Further review of the SARS-Co-V-2 patient tests results revealed of the 8,840 patients tested for SARS-Co-V-2, 2,625 patients tested positive and 6,215 patients tested negative. 3. Review of the laboratory's SARS-Co-V-2 result reporting revealed the laboratory had no documentation of SARS-Co-V-2 positive and negative test result reporting for 8 of 8 months reviewed (January 2021 - August 2021). 4. During an interview on 12/21 /2021 at 11:45am in the conference room with the Technical Consultant (TC-1), and the Lead Testing Person (TP-1), the Technical Consultant and Lead Testing Person 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 -- could not provide documentation that SARS-Co-V-2 positive and negative test results were reported to the County Health Department or to the Department of State Health Services. This confirmed the above findings. -- 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 CFR 493.1100 Facility Administration 493.1403 Laboratory Director, (moderate complexity). 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 D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation, confirmed by staff interview, the laboratory failed to participate in the third hematology testing event of 2018. Findings: 1. API PT results were reviewed, revealing scores of zero for all parameters in hematology for the 3rd event of 2018. The scores were accompanied with a notation "failure to participate." 2. In an interview at the site on 10-09-2019, testing person 1 (TP 1, CMS form 209) stated that she was generally responsible for ensuring PT was completed and submitted on time, but during the 3rd event testing of 2018 she had been on extended medical leave. 3. In the same interview TP 1 confirmed that patient testing had not been suspended during the event. Review of API PT documentation showed that the laboratory had participated successfully in the previous two PT events. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)