Summary:
Summary Statement of Deficiencies D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on surveyor review of patient test reports and laboratory procedures, and interview with testing personnel, the laboratory has not retained duplicate copies of the original report when the laboratory issued a corrected report. Findings include: 1. Review of the test report for patient one showed the report included a correction. The original report was not available. 2. Review of laboratory procedures showed the procedures did not require retention of the original report when the laboratory makes a correction to the report. 3. Interview with testing personnel, staff A, on July 30, 2019 at 11:00 AM confirmed the laboratory has not retained a copy of the original report when the laboratory issued a corrected report. 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 --