Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the review of the "Quality Assessment" procedure, critical value documentation on patient reports and interview with the technical consultant (TC), the laboratory failed to follow written procedure for the notification of critical values. Findings: 1. Review of the "Quality Assessment" procedure on page 2, POST ANALYTIC, item 2 revealed: "Notification of test results. Evaluate procedures for notification or reporting results, including verbal reports, abnormal and critical tests (including documentation of who reported the results, who received the results, and the date and time of the notification)'. Monitor for correct reports." 2. Review of selected patient reports with critical values revealed that two of two reports did not include: a. the name of the person reporting the critical result. b. the name of the person receiving the critical result. c. the date and time of the notification. 3. Interview with the TC on 11/13/24 at 11:55 a.m. confirmed, the laboratory failed to follow written procedure for the notification of critical values. 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 --