Summary:
Summary Statement of Deficiencies 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 test report and interview with the technical consultant at 12:00 PM on 5/15/2019, the laboratory run date and time on the test report changes on copies generated at a later time. 1. Review of 1 patient test report for complete blood counts, collection date of 5/13/2019 revealed a collection date and time, a received date and time, status (indicating status with date and time) and, run date and time. The run date and time changed with subsequent printing of the report. 2. Interview with the technical consultant confirmed the run date and time changed with subsequent printing. 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 --