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 record review and interview with the Histology Laboratory Manager, the laboratory failed to establish a competency assessment policy for testing personnel performing tick identification testing for 2 (April 2021 to April 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's personnel competency records revealed a lack of competency assessments for the performance of tick identification testing from April 2021 to April 2023. 2. An interview on 4/18/21 at 3: 00 pm with the Histology Laboratory Manager confirmed the laboratory had not established a process for the competency assessment process for testing personnel performing tick identification testing. 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 record review and interview with the Histology Laboratory Manager, the laboratory failed to verify the accuracy of its tick identification testing at least twice annually for 2 (April 2021 to April 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's Internal and External Quality Review documentation from 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 -- April 2021 to April 2023 revealed a lack of documentation of verification of accuracy testing for its tick identification testing. 2. An interview on 4/18/21 at 3:00 pm with the Histology Laboratory Manager confirmed the laboratory had not performed verification of accuracy testing for its tick identification testing. -- 2 of 2 --