Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey conducted 12/11/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 direct observation, laboratory policy, quality control (QC) documentation (2022-2023), and confirmed in interview, the laboratory failed to retain QC documentation for 12 of 12 months in 2022 and 6 of 11 months in 2023 (January- November). Findings included: 1. During a tour of the laboratory on 12/11/2023 at 01: 05 p.m., the surveyor observed a Medonic M-Series Hematology Analyzer (Serial Number: 27011) in the patient test area. 2. Review of laboratory policy, "Quality Control Guidelines" (Approved by the Laboratory Director on 01/07/2014) revealed the following: "Medonic M-Series External Quality Control ...Quality Control Failure ...Document all troubleshooting failures on the appropriate form for later reference." 3. Review of laboratory hematology QC documentation for 2022 and 2023 (January- November), revealed multiple QC failures in February and March 2023. The surveyor requested