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 peer review records, and interview with the office manager (OM), the laboratory failed to ensure that the verification of accuracy for MOHS micrographic surgery slide examinations were performed at least twice annually in 2022. Findings Include: 1. On the day of the survey, 02/21/2022 at 01:00 pm, the laboratory could not provide documentation that the verification of accuracy for MOHS micrographic surgery slide examinations stained using hematoxylin and eosin (H&E) were performed at least twice annually in 2022. 2. The laboratory performed 1054 MOHS micrographic surgery slide examinations in 2022 (annual volume listed on form CMS-116). 3. The OM confirmed the findings above on 02/21 /2023 around 01:30 pm. 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: 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 -- Based on review of the laboratory's quality control (QC) records and interview with the office manager (OM), the laboratory failed to document Hematoxylin and Eosin (H&E) QC monitoring activities for intended reactivity each day of patient testing for MOHS micrographic surgery slide examinations performed from 03/03/2021 to 09/27 /2022. Findings Include: 1. On the day of the survey, 02/21/2023 at 12:21 pm, review of the staining QC records revealed the laboratory did not document QC monitoring activities for intended reactivity each day of patient testing for MOHS micrographic surgery slide examinations stained using H&E for the following 17 of 542 days from 03/03/2021 to 09/27/2022: - 03/03/2021 - 04/21/2021 - 05/26/2021 - 06/01/2021 - 08 /31/2021 - 09/14/2021 - 09/15/2021 - 09/27/2021 - 01/27/2022 - 03/28/2022 - 05/10 /2022 - 06/16/2022 - 06/20/2022 - 07/28/2022 - 07/30/2022 - 08/02/2022 - 09/27/2022 2. The OM confirmed the finding above on 02/21/2023 around 01:30 pm. -- 2 of 2 --