Summary:
Summary Statement of Deficiencies 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 the laboratory's test menu, review of the laboratory's records from 2023 and 2024, and staff interview, the laboratory failed to have documentation of performing twice annual accuracy assessments for KOH testing in 2023 and 2024. The findings included: 1. A review of the laboratory's test menu determined the laboratory performed KOH testing in 2023 and 2024. The laboratory reported performing 115 KOH tests annually. 2. A review of the laboratory's records from 2023 and 2024 determined the laboratory failed to have documentation of assessing the accuracy of KOH testing twice in 2023 and 2024. 3. The practice manager confirmed the findings after his review of the records on 02/12/2025 at 10:30 hours in the break room. KEY KOH - potassium hydroxide D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records and staff interview, the laboratory failed to have documentation of the technical consultant performing semiannual competency assessments within the first year on 3 of 3 testing personnel. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The findings were: 1. A review of the laboratory's personnel records identified 3 testing personnel who required semiannual competency assessments. They were (as listed on Form CMS 209): a) Testing personnel number 3 hired: 5/2023 b) Testing personnel number 4 hired: 9/2023 c) Testing personnel number 5 hired: 02/2022 2. The laboratory failed to have documentation of the semiannual competencies being performed. 3. The practice manager confirmed the findings in an interview conducted on 02/12/2025 at 11:30 hours in the break room. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records and staff interview, the laboratory failed to have documentation of the technical consultant performing annual competency assessments on 2 of 2 testing personnel. The findings were: 1. A review of the laboratory's personnel records identified 2 testing personnel who required annual competency assessments. They were (as listed on Form CMS 209): a) Testing personnel number 1 hired: 2011 b) Testing personnel number 2 hired: 2018 2. The laboratory failed to have documentation of the annual competencies being performed. 3. The practice manager confirmed the findings in an interview conducted on 02/12 /2025 at 11:30 hours in the break room. -- 2 of 2 --