Summary:
Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of pathology test reports and interview with the facility personnel, the laboratory failed to maintain a record system that includes the identity of the individual who performs the gross description on histopathology specimens. Findings include: 1. The laboratory performs the gross description of pathology specimens under the sub-specialty of histopathology, with an approximate annual test volume of 2,600. 2. One test report reviewed during the survey (THS20-10182) failed to include the identity of the testing personnel who performed the gross description. The laboratory failed to indicate the identity of the testing personnel who performed the gross description on any other laboratory records. 3. The facility personnel confirmed that the test reports generated by the laboratory at the time of the survey conducted on May 13, 2021 failed to include the identity of the testing personnel who performed the gross description on patient specimens. 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 --