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 patient test records and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at approximately 1:15 pm on 2/2/2021, the laboratory failed to include the identity of testing personnel for four out of four patients who had testing performed in September 2020. The findings include: 1. Patient identifier #1 had Rh typing performed on 9/2/2020. 2. Patient identifier #2 had a wet mount performed on 9/4/2020. 3. Patient identifier #3 had Rh typing performed on 9/16/2020. 4. Patient identifier #4 had a wet mount performed on 9/28/2020. 5. At the time of the survey, the laboratory did not have records documenting the identity of the testing personnel for the above patients. 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 --