Summary:
Summary Statement of Deficiencies D0000 An onsite announced recertification survey was conducted on September 6, 2024 at the clinical laboratory of Perry Dermatology and Dermatopathology by the South Carolina Department of Public Health's Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with 42 CFR Part 493, CLIA Requirements for Laboratories. The following is a description of Standard level deficiencies cited: D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory documentation and staff interview, the laboratory failed to have a written Quality Assessment Policy. Findings included: 1. Review of laboratory policy and procedures reveals a lack of a written procedure for Quality Assessment. 2. In a interview with the Laboratory Director on September 6, 2024 at 12:00pm in the laboratory office, the finding was confirmed. 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. 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 -- This STANDARD is not met as evidenced by: Based on the lack of laboratory documentation and staff interview, the laboratory failed to document all control procedures performed. Findings included: 1. Review of laborarory records reveals a lack of documentation of control procedures performed in the laboratory. 2. Review of laboratory records reveals a lack of biannual peer review of tissue diagnosis. 3. In a staff interview on September 6, 2024 in the laboratory office at 12:00pm, the findings were confirmed. -- 2 of 2 --