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 record review and interview with the technical consultant (TC), the laboratory failed to retain analytic systems records for at least two years. Findings: 1. The laboratory performs hematology testing on an ABX Pentra 60 C+ hematology analyzer. During a tour of the laboratory at 10:00 AM, the TC stated that documentation of lot numbers and expiration dates of reagents used on the hematology analyzer are maintained on the analyzer itself. 2. Upon investigation, the TC stated that the hematology analyzer maintained reagent lot numbers and expiration dates from 10/22/2022 to present. The TC was able to locate archived reagent information back to 09/14/2022. 3. During an interview on 11/03/2023 at 11:45 AM, the TC stated that the laboratory's current procedure for archiving documentation of reagent lot numbers and expirations dates causes older information to be overwritten by the newest back-up. They confirmed that the laboratory did not retain hematology reagent information for at least two years. 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 --