Summary:
Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview an with the Mohs Technician, the laboratory failed to document quality control (QC) for Hematoxylin and Eosin (H&E) Mohs testing procedures for three out of 378 days of patient testing from 09/01/2021 through 08/01/2023. Sixteen out of 3,982 patients tested from 09/01/2021 through 08 /01/2023 had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "Verification of H and E Performance Standard" policy and procedure found the following statement: "I verify that the established performance standards of a crisp, clear appearance of the Hematoxylin (purple) stain and the Eosin (pink) stain, clearly evident tissue structures, and clarity of the slide have been met for the follow QC slides that I have reviewed prior to testing patient specimens..." 2. Review of the laboratory's QC data from 09/01/2021 through 08/01 /2023 found three out of 378 days that H&E Mohs patient testing was performed without QC documentation. This deficient practice had the potential to affect 16 patients. 09/30/21 QC Patient 1 [none] Patient 2 [none] Patient 3 [none] Patient 4 [none] 12/23/2021 QC Patient 1 [none] Patient 2 [none] Patient 3 [none] Patient 4 [none] Patient 5 [none] Patient 6 [none] 06/16/2022 QC Patient 1 [none] Patient 2 [none] Patient 3 [none] Patient 4 [none] Patient 5 [none] Patient 6 [none] 3. The surveyor requested QC documentation of H&E Mohs patient testing for the days 09/30 /21, 12/23/2021 and 06/16/2022. 4. An interview with the Mohs Technician, on 08/01 /2023 at 2:39 PM, confirmed that the laboratory failed to document QC of H&E Mohs 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 -- testing for the days 09/30/21, 12/23/2021 and 06/16/2022 which had the potential to affect 16 patients. -- 2 of 2 --