Atlantic Dermatology & Laser Center

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), observation of the Microscope, lack microscope maintenance records records and interview with the Office Manager (OM), the laboratory failed to follow their policy for "Equipment Quality Control - Microscope Use Protocol" in the calendar years 2020, 2021 and 2022. The finding includes: 1. The "Equipment Quality Control - Microscope Use Protocol" stated "2. Microscope gets preventative maintenance once yearly" 2. There was no documented evidence that the above mentioned procedure was performed. 3. The OM confirmed on 10/27/22 at 10:30am the laboratory did not follow the PM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 observation of Quality Control (QC) records, accession log, and interview with the Office Manager (OM), the laboratory failed to document the reactions of the QC slides for Periodic acid-Schiff (PAS) stains and Grocott methenamine-silver (GM) used for Histopathology slides on 10/30/17. The findings include: 1. There was no QC documented for PAS and GM stains on 10/30/17. 2. Approximately 19 Patients were affected. 3. The OM confirmed on 1/24/18 at 10:00 am that the QC reactions were not documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --