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's review of the Beckman AU480 chemistry analyzer's Quality Control (QC) records, calibration records and maintenance records and an interview with the laboratory director, the laboratory failed to retain the calibration verification records for August 2, 2019 and February 2, 2020. FINDINGS: The laboratory director confirmed on August 31, 2021 at approximately 2:00 PM, that he could not locate the calibration verification records for the AU 480 chemistry analyzer for these dates August 2, 2019 and February 2, 2020. 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 --