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: Review of the CMS 209 Laboratory Personnel Report, policies and procedures, personnel records and interview of facility personnel found that the laboratory failed to have a procedure in place to evaluate the competency of one technical supervisor and two general supervisors performing high complexity procedures in Histopathology . Findings included: 1. Review of the CMS report 209 Laboratory Personnel Report found that the laboratory designated two general supervisors and one technical supervisors for high complexity testing. 2. Review of policies and procedures found that the laboratory had no policy or procedure for assessing the competency of supervisors performing high complexity testing in Histopathology . 3. Review of personnel files found no documentation of competency assessment for the two general supervisors and the technical supervisors performing high complexity testing in histopathology. 3. During interview of the general supervisor 1 listed on the CMS report 209 conducted on June 5, 2024 at 10:10 AM, he confirmed that the laboratory had not evaluated the competency of the general supervisors and the technical supervisor performing high complexity testing in Histopathology. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of policies and procedures, proficiency testing (PT) records, and interview of facility personnel, the laboratory failed to have documentation of performing semi-annual accuracy assessments for histopathology slide interpretations for 2023. The findings included: 1. Review of the policies and procedures found no procedure available for review for assessing the accuracy of results for Histopathology slide interpretations. 2. The laboratory failed to have documentation of performing semi-annual accuracy assessments for histopathology slide interpretations in 2023. 3. During interview of general supervisor 1 on the CMS report 209 conducted June 5, 2024 at 11:22 AM, he confirmed that the laboratory started testing in June 2023 and did not perform accuracy assessments for histopathology semiannually in 2023. -- 2 of 2 --