Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's patient test records, and interview with the laboratory director and testing person on April 24, 2023, at 12:50 pm, the laboratory failed to retain patient test records. The findings include: 1. The laboratory performed SARS-CoV-2 PCR test. The test method includes signal detection with the PCR instrument. The laboratory transcribed the PCR results from the instrument and entered into the laboratory information system for reporting. Therefore, the transcribed data considered as part of patient test records and the laboratory must retain the original and the transcribed copy for 2 years. However, the laboratory did not retain the copy of the transcribed data. Therefore, the accuracy of the transcribed data can not be assured and may have affected patient care. 2. The laboratory testing person on April 24, 2023, at 12:50 pm, affirmed that the laboratory did not save the copy of the transcribed data. 3. The laboratory's testing declaration form, signed by the laboratory director on 4/24/2023 stated that the laboratory performs approximately 3,600 tests, annually. D5779