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 lack of documentation and interview with the Center Manager (CM), the laboratory failed to retain quality control (QC) records for 4 of 4 Reichert TS Meters used to perform total protein (TP) examinations for at least 2 years from 6/10/2023 to 06/10/2025. Findings include: 1. On the day of survey, 6/10/2025 at 11:00 am, the laboratory failed to provide requested QC records for 4 of 4 Reichert TS Meters used to perform total protein examinations from 6/10/2023 to 6/10/2024. 2. The laboratory performed 45,079 Total Protein examinations in 2024 (CMS 116 annual volume). 3. The CM confirmed during interview on 6/10/2025 at 1:00 pm, the laboratory changed ownership (June 2024) and failed to retain all QC records for the last 2 years. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on lack of documentation, review of American Associates of Bioanalysts- Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, and interview with the center manager (CM), the laboratory failed to document the evaluation and verification activities performed for 1 of 3 AAB-MLE Chemistry Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- events for 2023. Findings Include: 1. On the day of survey, 06/10/2025 at 10:00, a review of AAB-MLE PT records revealed the laboratory received a score of 80% for 1 of 3 AAB-MLE PT events (Chemistry M3 2023) for total protein testing performed in 2023. 2. The laboratory's Technical Consultant Review of Proficiency Testing Results for Q3 2023 Quadrimester memo stated, "DON-102 requires the center to score no less than 100%. Center to take