Summary:
Summary Statement of Deficiencies D0000 An announced, on site, initial certification survey was conducted at Mon Health Wedgewood Primary Care on September 29, 2022, by the West Virginia Office of Laboratory Services. The laboratory was assessed fro 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 record review and interview the laboratory failed to ensure that (c)(6) the units of measurement and the interpretation for the test results are present on the final electronic test report for two of two patient CBCs in 2022. Findings: 1. Review of the two patient CBC test results in 2022 identified no units of measurement and no interpretation of results for the hematology testing reported (WBC, RBC, Hgb, HCT, MCV, MCH, MCHC, RDW, Platelet, MPV) on the final electronic test report. 2. An interview with the laboratory manager, 9/29/22 at approximately 10:30 AM, confirmed the 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 --