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: Through a review of quality control (QC) records for May 2026, lack of documentation, patient results, and interviews with laboratory staff, the laboratory failed to retain QC records for chemistry testing performed on the Architect Plus 4000 chemistry analyzer for at least two years. Survey findings include: A) Review of Chemistry QC records for May 2026 revealed that no records were presented for Cholesterol and Comprehensive Metabolic Profile (CMP) analysis performed on the Architect Plus 4000 chemistry analyzer on May 1, 2026. B) Upon request, the laboratory was unable to provide QC records for Cholesterol and CMP testing performed on May 1, 2026 C) Review of patient results revealed that 33 cholesterol assays and 48 CMP profiles were performed and reported on 5/1/26. D) In an interview, at 02:45 p.m. the laboratory staff member (# 2 on the form CMS-209) stated that the QC results for Cholesterol and CMP testing performed on 5/1/26 were not available. D5783