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 twice annual accuracy assessment records from 2022 and 2023, and staff interview, the laboratory failed to have documentation of performing 3 of 4 accuracy assessments in 2022 and 2023. The findings included: 1. A review of the laboratory's twice annual accuracy assessment records from 2022 and 2023 determined the laboratory failed to have documentation of performing one accuracy assessment in 2022 and two accuracy assessments in 2023. 2. The clinical operation manager confirmed the findings in an interview conducted on 06/20/2024 at 1007 hours in the break room. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's MOHS stain QC assessment log from 2023, review of the laboratory's patient information log from 2023, and staff interview, the 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 -- facility failed to document stain quality on 4 of 33 days. The findings included: 1. A review of the laboratory's MOHS stain QC assessment log from 2023 identified the following 4 days where the stain quality was not documented: March 27, 2023 April 10, 2023 May 20, 2023 November 25, 2023 2. A review of the laboratory's patient information logs from 2023 identified the following patients tested on the identified days: a) March 7, 2023 MOHS#: R034 R041 R042 R043 b) April 10, 2023 MOHS#: R050 R051 R052 R053 R054 c) May 2, 2023 MOHS#: R067 R068 R069 R070 R071 R072 d) November 25, 2023 MOHS#: R174 R175 R176 R177 R178 R179 R180 R181 R182 3. The clinical operations director confirmed the findings in an interview conducted on 06/20/2024 at 1007 hours in the break room. -- 2 of 2 --