Summary:
Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and an interview with the Laboratory Director (LD), the laboratory failed to review test accuracy verification results. Findings were as follows: 1. The surveyor was presented with the "Skin Diagnostics Inc, Policy and Procedure Manual", updated April 2018. 2. During a review of test accuracy verification records, five selected cases for accuracy assessment were forwarded to AccuPath/DermPath for peer review. Five cases selected: D17-674 D17- 51 D17-24 D17-77 D17-009 2. The LD provided an "AccuPath Quality Management" peer review sheet which did not contain any dates of submission, peer review signature dates or dates of LD review. The laboratory director confirmed no review of the AccuPath/Derm peer reviewed cases was documented. The interview occurred on 04/17/2018 at 9:53 AM. 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: REPEAT DEFICIENCY Based upon a review of lab policies, proficiency and accuracy assessment testing records and an interview with the Laboratory Director (LD), the laboratory failed to perform test accuracy verification twice annually. 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 -- Findings were as follows: 1. The surveyor was presented with the "Skin Diagnostics Inc, Policy and Procedure Manual", updated April 2018. 2. During a review of test accuracy verification records, five selected cases for accuracy assessment were forwarded to AccuPath/DermPath for peer review. Five cases selected: D17-674 D17- 51 D17-24 D17-77 D17-009 2. The LD provided an "AccuPath Quality Management" peer review sheet which did not contain any dates of submission, peer review signature dates or dates of LD review. The laboratory director verified no dates for peer review had been documented during 2016, 2017 and 2018. The interview occurred on 04/17/2018 at 9:53 AM. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved