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 laboratory record review, lack of documentation and interview with staff, the laboratory failed to retain calibration verification and maintenance records for at least two years for 2 of 2 analyzers in use prior to 07/28/2017. Finding include: 1. Laboratory calibration verification and maintenance records failed to include records for the Sysmex XS 1000 complete blood count analyzer and the Architect C 4000 chemistry analyzer. 2. Staff stated on 09/25/2018 at approximately 3:00 p.m. the laboratory had undergone a change in management and test menu in 07/2017 and testing on the Sysmex and Architect were discontinued. Current staff were unable to find onsite records for the discontinued analyzers. 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 --