Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) (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 and interview with testing personnel (TP) #2, the laboratory failed to include the test report date on the patient test report. Findings: 1. Review of a selected patient test reports revealed the performing laboratory's test report date was not on the patient test report. 2. Interview with TP #2 on 03/12/25 at 10:45 a.m. confirmed, the laboratory failed to include the test report date on the patient test report. D5813 TEST REPORT CFR(s): 493.1291(g) (g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of patient test reports with critical values and interview with TP #2, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- the laboratory failed to document the immediate alert of the critical or panic test result value(s) to the individual responsible for using the test results in the test report for 2023, 2024, and to date of survey 2025. Findings: 1. Review of selected patient test reports with critical values revealed no documentation of: a. alerting the individual or entity responsible for using the test results of the critical or panic test result value(s) b. date and time of the critical alert. 2. Interview with TP #2 03/12/25 at 10:45 a.m. confirmed, the laboratory failed to document the immediate alert of the critical or panic test result value(s) to the individual responsible for using the test results in the test report for 2023, 2024, and to date of survey 2025. -- 2 of 2 --