Summary:
Summary Statement of Deficiencies D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and confirmed through an interview with the technical consultant (TC), the TC failed to assess the competency of all testing personnel (TP) through testing previously analyzed specimens, internal blind testing samples or external proficiency testing (PT) samples in the specialty of Chemistry. Findings include: 1. Record review on 11/8/2023 of the laboratory's 2022 American Proficiency Institute PT attestation sheets revealed 1 of 2 moderate complexity TP did not have their competency assessed through testing external PT samples in the specialty of Chemistry. 2. Record review on 11/8/2023 of the laboratory's PT policy revealed, "All PT samples will be tested in the same manner as patient samples. The personnel who routinely process patient samples will perform the PT using the instruments/test kits used for patient testing." 3. Record review on 11/8/2023 of the 2022 competency assessment records for TP#1 revealed: a. Assessment of test performance through external PT was checked off as being performed. b. The competency record was signed by the TC as reviewed. 4. Staff interview on 11/8/2023 at 10:26 AM with the TC and TP#1 confirmed: a. TP#1 did not perform PT or test a previously analyzed or blind sample in 2022 in the specialty of Chemistry. b. The TC also confirmed the above indicated competency sheet was signed as completed for PT. 5. The laboratory performs 176,688 tests annually in the specialty of 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 1 --