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 05/28/2026 and ertification is recommended. Standard level deficiencies were cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the review of the laboratory's records and confirmed in an interview, the laboratory failed to have personnel competency assessment policy. The findings were: 1. Review of the laboratory's records revealed no policy available for personnel competency assessment. 2. In an interview on 05/28/2026 at 11:17 am via the phone, the manager confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's 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 -- criteria for acceptability. This STANDARD is not met as evidenced by: Based on the review of the laboratory's patient frozen section logs, patient's final reports from 02/18/2026 to 05/11/2026, and confirmed in an interview, the laboratory failed to include the address of the laboratory where gross was performed for 3 of 4 patient final reports. The findings were: 1. Review of the laboratory's patient frozen section logs revealed the laboratory's 1st frozen case was on 02/18/2026. 2. In an interview on 05/27/2026 at 13:00 pm in the lab, the histotech confirmed gross procedure was performed onsite if gross description on the patient final report stated "specimen was received fresh or frozen section ...". Gross procedure was performed in Sherman TX location laboratory if gross description on the patient final report stated "specimen in formalin ...". 3. Review of the laboratory's patient final reports from 02 /18/2026 to 05/11/2026 revealed the laboratory failed to include the address of the laboratory where the gross was performed for 3 of 4 patient final reports. 02/18/2026 Case ID: RS26-0516 04/06/2026 Case ID: RS26-1303 05/11/2026 Case ID: RS26- 1896 4. In an interview on 05/27/2026 at 13:10 pm in the lab, the manager and the histotech confirmed the above findings. -- 2 of 2 --