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. In addition, retain the following: This STANDARD is not met as evidenced by: Based on the review of the laboratory's protocol for retention of records, a total of twenty patient test records, lack of preventive maintenance (PM) records, and interviews with the director of operations on April 3, 2026; it was determined that the laboratory failed to retain the PM records for the micrscopes used in testing. The findings include: 1. The laboratory's policy was to perform PM for the microscopes annually through Western Scientific Co (WesCo). However, the only available record for review was for 2025. 2. The surveyor reviewed a total of twenty patient records that required the use of the micrscope for test performance. Fourteen out of twenty were potentially affected due to lack of records from 2023, 2024 and 2026. 3. There was a lack of