Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5805 TEST REPORT CFR(s): 493.1291(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 criteria for acceptability. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 116 application, patient reports from 11/7 /22 to 11/15/22 and confirmed in an interview found the laboratory failed to have correct testing facility address on patient testing reports. The findings were: 1. Review of CMS 116 application signed by the laboratory direction on 11/11/22 revealed the facility address for the laboratory was 5000 Eldorado Pkwy Ste 420 Frisco, TX 75033. 2. Review of the laboratory's patient reports from 11/7/22 to 11/15/22 revealed the laboratory had 24 patient reports with incorrect testing facility address. 11/07/22 Medical Record#: 24787 11/07/22 Medical Record#: 24057 11/08/22 Medical Record#: 24114 11/08/22 Medical Record#: 23029 11/08/22 Medical Record#: 25385 11/09/22 Medical Record#: 24355 11/09/22 Medical Record#: 25373 11/09/22 Medical Record#: 23384 11/10/22 Medical Record#: 25385 11/10/22 Medical Record#: 24286 11/11/22 Medical Record#: 24330 11/11/22 Medical Record#: 25426 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 -- 11/11/22 Medical Record#: 24186 11/11/22 Medical Record#: 25412 11/11/22 Medical Record#: 23907 11/11/22 Medical Record#: 24237 11/11/22 Medical Record#: 20365 11/11/22 Medical Record#: 25319 11/14/22 Medical Record#: 25418 11/14/22 Medical Record#: 25441 11/14/22 Medical Record#: 24986 11/14/22 Medical Record#: 25412 11/15/22 Medical Record#: 25426 11/15/22 Medical Record#: 23188 3. An interview with the medical assistant on 11/16/22 at 12:00 pm in a small conference room confirmed the above findings. Key: CMS=Center for Medicare and Medicaid Service -- 2 of 2 --