Ab Dermatology

Summary Statement of Deficiencies D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review and an interview with testing personnel (TP1), the laboratory failed to document all control procedures performed, as specified in the specialty of Histopathology for 49 patients. Findings Include: 1. The laboratory manual, Mohs accession logs, and quality control (QC) sheets were reviewed. 2. The patients for Mohs procedures are documented on the Mohs accession logs. The following dates were selected for QC record review: *02/14/2019; *05/23/2019; *08/01/2019; *12/12 /2019; *03/26/2020; *06/18/2020; *09/24/2020; *01/21/2021 and *04/08/2021; 3. The QC worksheets showed the laboratory failed to document the following information on the above (finding #2) selected test dates: *The lot numbers and expiration dates of the reagents and stains used in the performance of the Hematoxylin and Eosin (H & E) tissue staining procedure; and *Record the date prepared and/or opened when reagents and stains are put into use. 4. Further review of the Mohs accession logs revealed the laboratory processed 49 patients' tissue during the selected dates. 5. The laboratory manual and QC worksheet failed to include a written method that would ensure the required information for its reagents and stains are documented each day of tissue processing and staining. 6. On a Recertification survey conducted on 05/06/2021 at 12:45 PM, TP1 confirmed the above findings. 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 D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's manuals, logs, direct observations, and an interview with the staff manager; the laboratory failed to follow maintenance and function check protocols that ensures equipment, instrument, and test system performances are accurate and reliable. The laboratory must perform and document the maintenance activities. Findings: 1. On 11/27/2018 at 11:35 AM during a tour of the laboratory, the surveyor observed the following equipment in the laboratory: 1). A Microscope - attached maintenance label records 12/2015 as the last service date. 2). Biological hood (used for tissue staining) - attached maintenance label records 01/07 /2016 as the last date the filter was change. 3). A Cryostat; and 4). A Microtome 2. The procedure manual states the following in its "EQUIPMENT MAINTENANCE AND QUALITY CONTROL POLICY: "1. Service technicians will perform required annual maintenance ...." 3. The service receipts in the maintenance log reveal the following: A). The microscope was last serviced in December of 2015; B). The last filter change for the Biological hood was performed on 01/07/2016; C). The Cryostat was last serviced on 11/30/2017; and D). The Microtome had been serviced on 10/10 /2016 and 06/06/2018. No other documentation was provided as evidence 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 -- equipment maintenance had been performed annually as required in the laboratory's equipment policy. 4. On a Recertification survey conducted on 11/27/2018 at 1:15 PM the staff manager confirmed the above findings. -- 2 of 2 --