Summary:
Summary Statement of Deficiencies D0000 An announced, on site, initial survey was conducted at Boone Memorial Hospital Surgery on December 16, 2020, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. 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 the laboratory electronic medical record (EMR) for MOHs patients, MOHs patient maps, and an interview with testing personnel (TP1), the laboratory failed to provide a final test report for MOHs patients that contained the (c) (6) test results and the interpretation. Findings: 1. A review of the EMR for MOHs patients identified no final report for the test result and interpretation. Each patient EMR had a MOHs map as the final report. 2. A review of MOHs patient maps revealed no final test results and interpretations of the test on the MOHs map. 3. During an interview with TP1, 12/16/20 at approximately 10:45 AM, TP1 stated that the MOHs map was scanned into the patient EMR and was considered the final test report for MOHs patients. 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 --