Cynthia Rogers Md Pa

Summary Statement of Deficiencies D0000 Recertification survey was conducted on May 15, 2024. Cynthia Rogers MD PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 interview, review of the procedure manual, the accession log, and the stain maintenance log, the laboratory failed to follow their procedure for documenting stain reagents from 03/08/2023 to 05/15/2024 for 10 days that Mohs surgical procedures were performed. Findings: Review of the procedure titled, Quality Control noted, "Tracking of reagents (hematoxylin, eosin, 95% alcohol, 100% alcohol, clearing solution, mounting media, and freezing media) lot numbers, open dates, and expiration dates will be checked and recorded every day the Mohs surgery is performed." Review of the Mohs Log Book and Histology Stain Maintenance - Frozen logs showed the following days Mohs surgical procedures were performed and no documentation was recorded: 12/15/2022 - 2 patients 04/13/2023 - 1 patient 04/27 /2023 - 2 patients 06/29/2023 - 1 patient 08/03/2023 - 1 patient 09/21/2023 - 1 patient 09/28/2023 - 1 patient 10/25/2023 - 8 patients 11/16/2023 - 1 patient 02/15/2024 - 1 patient On 05/15/24 at 12:02 PM, the Practice Manager stated they performed Mohs surgical procedures once a week and occasionally performed Mohs surgeries the next 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 -- day. The Practice Manager acknowledged they did not record the stain maintenance on the next day. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on March 7, 2022. Cynthia Rogers MD PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to record the room temperature and humidity of rooms where testing was performed from 03/07/2020 to 03/07/2022. Findings: Review of the Instructions for Use manual for the laboratory's Leica CM1520 Cryostat noted room temperatures should be between 18 - 35 degrees Celsius and maximum humidity of the room should be 60% (percent). A review of the laboratory's logs showed the laboratory failed to record the room temperature and the humidity of the room where testing was performed. During an interview 03/07/2022 at 3:02 PM, the Practice Manager stated they did not record the room temperature nor the humidity of the laboratory. 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 --