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 reports, prostatic specimen antigen (PSA) logs, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 1:45 pm on 2/13/2020, the laboratory failed to have the correct test report date on two out of three patient test reports (Patient A and B) who had PSA testing performed in November 2019. The findings include: 1. Patient A had a PSA specimen collected on 11/6/2019. The laboratory performed the PSA testing on 11/7/2019. The test report for Patient A indicated the laboratory performed the test on 11/6/2019. 2. Patient B had a PSA specimen collected on 11/7/2019. The laboratory performed the PSA testing on 11/8/2019. The test report for Patient B indicated the laboratory performed the test on 11/7/2019. 3. At the time of the survey, the test reports for the above patients did not have the correct date of testing. 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 --