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 records and interview with the laboratory director, the laboratory did not retain accurate expiration dates for quality control (QC) performed on the Sysmex XN-330 hematology analyzer from May through August 2022 and did not document changes in lot numbers and expiration date during the month of use. Findings include: 1. Review of the "Sysmex Maintenance Log" showed the following QC lot numbers and expiration dates: Month/Lot/Expiration date recorded May/2070/June 21, 2022 June/2070/June 7, 2022 July/2154/July 11, 2022 August/2154/August 15, 2022 Further review showed no documentation of when new lots were opened and in use. 2. Interview with the laboratory director on November 9, 2022, at 12:15 PM confirmed the laboratory did not retain accurate expiration dates for quality control (QC) performed on the Sysmex XN-330 hematology analyzer from May through August 2022 and did not document changes in lot numbers and expiration date during the month of use. 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 --