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 review of proficiency testing records (PT) and interview with the technical consultant, the laboratory failed to retain all proficiency testing records for at least 2 years. Findings: 1. PT records showed that the laboratory failed the 1st PT event of 2019 with an overall score of 60%. 2. There was no documentation to show that the laboratory used the work sheet provided by American Proficiency Institute (API) to record its PT results. 3. As part of the investigation of the PT failure for the 1st PT event of 2019, The laboratory documented that there was a mix-up of PT samples when it analyzed PT specimens and reported the results. 4. Based on review of PT worksheets, the survey could not determine if there was a mix-up of PT samples. 5. At 1:00 PM on February 20, 2020, the technical consultant confirmed the surveyor's 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 --