Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory personnel records and an interview with the laboratory manager, the laboratory failed to assess the competency of 4 out of 4 testing personnel performing potassium hydroxide (KOH) testing since the last survey on 10/12/2020. Findings include: 1. A review of laboratory personnel records revealed the laboratory failed to document the competency assessment for 4 out of 4 testing personnel performing KOH testing since the last survey. 2. The laboratory performed approximately 25 KOH tests annually. 3. An interview with the laboratory manager on 7/17/2023, at approximately 3:00 PM, confirmed the laboratory failed to assess the competency of the testing personnel. 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 a record review and an interview with the laboratory manager, the laboratory failed to perform twice annual verification testing for potassium hydroxide (KOH) during 2021 and 2022. Findings include: 1. A review of laboratory records revealed the laboratory failed to document the verification of KOH testing at least 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 -- twice year for 2021 and 2022. 2. The laboratory performed approximately 25 KOH tests annually. 3. An interview with the laboratory manager on 7/17/2023, at approximately 2:30 PM, confirmed the laboratory failed to perform and document twice a year verification for KOH. This is a repeat deficiency from the last survey on 10/12/2020. -- 2 of 2 --