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 and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at 10:22 am on 5/29/2024, the laboratory failed to retain all proficiency testing records for four out of seven proficiency testing events from 1/1/2022 - 5/29/2024. The findings include: 1. For 2022 testing event 1, the laboratory did not retain the proficiency testing results from the Frend analyzer or the attestation statement. 2. For 2022 testing event 2, the laboratory did not retain the proficiency testing results from the Frend analyzer. 3. For 2023 testing event 2, the laboratory did not retain the proficiency testing results from the Frend analyzer or the attestation statement. 4. For 2024 testing event 1, the laboratory did not retain the proficiency testing results from the Frend analyzer. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing results and confirmed by laboratory personnel #1 (refer to the Laboratory Personnel Report) at 10:22 am on 5/29/2024, the laboratory failed to verify the accuracy at least twice annually for the analyte, testosterone for one out of two time periods from 1/1/2023 - 12/31/2023. The findings include: 1. The laboratory enrolled in proficiency testing for the analyte, testosterone Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- in 2023. 2. For 2023 testing event 1, the laboratory did not participate in the event. 3. For 2023 testing event 3, the laboratory did not participate in the event. 4. The laboratory only participated in 2023 testing event 2, and did not verify accuracy by another method. D5783