Summary:
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. 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 review of patient records and confirmed in interview, the laboratory failed to include the testing facility address on the final reports for 7 of 7 patients in 2022 (April to November) Findings included: 1. Review of patient records from 2022 revealed the following 7 final reports which did not include the testing facility address: 4/18/2022 Accession #: N-22-04584 06/10/2022 Accession #: N-22-02133 06 /22/2022 Accession #: N-22-02425 07/15/2022 Accession #: N-22-02770 09/30/2022 Accession #: N-22-04068 10/31/2022 Accession #: N-22-04584 11/18/2022 Accession #: N-22-04702 2. During the exit interview at 11:00 am, the laboratory representatives, after review of records, confirmed the above findings. 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 --