Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing (PT) records for one of six events in the past 2 years. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Assistant Manager of Quality during a tour of the laboratory on March 22, 2023 at 10:10 a.m. 2. The laboratory performed PT using the American Association of Bioanalysts (AAB) provider. 3. The AAB Chemistry Quarter 2, 2022, final results were not present in laboratory records on date of survey. The laboratory was able to print the results off the AAB website during the survey. The laboratory was unable to provide a copy of this document that had been reviewed by the appropriate staff at the time the results were received by the laboratory. 4. In an interview on at 10:45 a.m., The Assistant Manager of Quality confirmed the above findings. 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 --