Summary:
Summary Statement of Deficiencies D0000 During an offsite paper revisit the laboratory was found to be in compliance with the CLIA regulations (42 CFR Part 493 effective April 24, 2003.) No 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 a review of patient test reports and an interview with testing personnel 1 (TP1) on 9/25/2024, the laboratory failed to indicate the name and address of the performing laboratory for reported tests. The findings include: 1. A review of laboratory patient test reports for chemistry testing identified that the laboratory failed to indicate the name and address of the performing laboratory for onsite testing since beginning patient testing in July of 2024. 2. An interview with TP1 on 9/25/2024 at 10: 34 am confirmed the above finding. 3. The laboratory reports performing 1,560 tests annually. 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 --