Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dermatology of Century Village WPB LLC on February 25, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document maintenance and function checks for 13 days of the maintenance logs reviewed from 02/06/2024 to 02/25/2026. Findings Included: 1. Review of the Hematoxylin and Eosin (H&E) Staining Maintenance Log revealed, the stain maintenance (changing, rotating, filtering) was not documented for 05/12/2025, 05/19/2025, 11/04/24 and 06/30/2025. 2. Review of the Mohs Accession Log showed there were 9 Mohs surgical procedure on 05/12/2025, 7 on 05/19/2025, and 8 on 06/30/2025. 3. Review of Mohs Daily QC (quality control) log used in 2024 showed, the laboratory used the log to document the H&E stain maintenance, the reagents lot number and expiration, the cryostat maintenance, cryostat temperature, room temperature, room humidity, microscope maintenance, and the H&E stain quality. 4. Review of Mohs Daily QC log showed there was no documentation on 08/22/2024, 08/29/2024, 09/05/2024, 09/12/2024, 09 /19/2024, 09/26/2024, 10/03/2024, 10/24/2024, 10/31/2024, 11/07/2024. 5. Review of the Mohs Accession Log showed there were 11 Mohs surgical procedure on 08/22 /2024, 6 on 08/29/2024, 10 on 09/05/2024, 7 on 09/12/2024, 7 on 09/19/2024, 8 on 09 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 -- /26/24, 7 on 10/03/2024, 8 on 10/24/2024, 9 on 10/31/2024, and 7 on 11/07/2024. 6. During an interview on 02/25/2026 at 2:05 PM, the Vice President of Laboratory Operations acknowledged, the maintenance logs were not completely filled out and some were missing. 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. This STANDARD is not met as evidenced by: Based on review of the procedure manual, record review, and interview, the laboratory failed to document the acceptability of the Hematoxylin and Eosin (H&E) quality control (QC) slide for 29 days (02/22/2024, 02/29/2024, 03/07/2024, 03/14 /2024, 03/28/2024, 04/04/2024, 04/11/2024, 04/18/2024, 04/25/2024, 05/09/2024, 05 /23/2024, 06/20/2024, 07/18/2024, 08/01/2024, 08/15/2024, 08/22/2024, 08/29/2024, 09/05/2024, 09/12/2024, 09/19/2024, 09/26/2024, 10/03/2024, 10/24/2024, 10/31 /2024, 11/04/2024, 11/07/2024, 11/14/2024, 11/21/2024, 06/09/2025) of the control log reviewed from 02/06/2024 to 02/25/2026. Findings: 1. Review of the procedure titled Quality Assurance, signed and dated on 01/06/2026 by the Laboratory Director noted, "First slide of the day will be reviewed for stain quality" will be reviewed and the "quality control slide will be documented on the Hematoxylin and Eosin quality control sheet." 2. Review of Mohs Daily QC log showed the Mohs surgeon failed to document the acceptability of the H&E stain by signing the form on 02/22/2024, 02/29 /2024, 03/07/2024, 03/14/2024, 03/28/2024, 04/04/2024, 04/11/2024, 04/18/2024, 04 /25/2024, 05/09/2024, 05/23/2024, 06/20/2024, 07/18/2024, 08/01/2024, 08/15/2024, 08/22/2024, 08/29/2024, 09/05/2024, 09/12/2024, 09/19/2024, 09/26/2024, 10/03 /2024, 10/24/2024, 10/31/2024, 11/04/2024, 11/07/2024, 11/14/2024, and 11/21/2024. 3. Review of the H&E Slide QC log showed, the stain quality was not documented on 06/09/2025. 4. Review of the Mohs Accession Log showed there were 5 Mohs surgical procedure on 02/22/2024, 6 on 02/29/2024, 8 on 03/07/2024, 6 on 03/14 /2024, 9 on 03/28/2024, 4 on 04/04/2024, 7 on 04/11/2024, 7 on 04/18/2024, 8 on 04 /25/2024, 7 on 05/09/2024, 6 on 05/23/2024, 11 on 06/20/2024, 7 on 07/18/2024, 6 on 08/01/2024, 9 on 08/15/2024, 11 on 08/22/2024, 6 on 08/29/2024, 10 on 09/05/2024, 7 on 09/12/2024, 7 on 09/19/2024, 8 on 09/26/24, 7 on 10/03/2024, 8 on 10/24/2024, 9 on 10/31/2024, 4 on 11/04/2024, 7 on 11/07/2024, 7 on 11/14/2024, 3 on 11/21/202, and 7 on 06/09/2025. 5. During an interview on 02/25,2026 at 2:08 PM, the Vice President of Laboratory Operations acknowledged the stain quality control logs were not signed by the Mohs Surgeon for the above mentioned days. -- 2 of 2 --