Summary:
Summary Statement of Deficiencies 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 systems Quality Assessment (QA) procedures, QA records, as well as interview with the General Manager (GM) and Regional Manager (RM), the laboratory failed to perform 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. FINDINGS: 1. There was no documentation of "Monthly Quality Assurance Checklist" records for February 2025 and August 2025. 2. The "Laboratory Quality Assurance" form was not completed from July 29, 2024, through October 1, 2025. 3. These are contrary to instructions indicated in the current, approved Quality Management Program procedure. 4. The GM and RM confirmed the findings on October 1, 2025, at approximately 4:30 P.M. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) 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. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of 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 review of Standard Operating Procedures (SOPs), maintenance records, as well as interviews with the GM and RM, the laboratory failed to perform and document maintenance activities. FINDINGS: 1. The "Maintenance of Lab" and "Hematoxylin & Eosin Quality Control and Maintenance" forms were not completed for November 4, 2024, and November 5, 2024. 2. This is contrary to instructions indicated in the current, approved SOPs. 3. Twenty-one total Mohs surgery specimens were processed, analyzed, and results released for November 4, 2024, and November 5, 2024. 4. The GM and RM assured the surveyor on October 1, 2025, at approximately 4:30 P.M. that the required maintenance was performed and the Testing Personnel (TP) failed to complete the respective forms. 5. The GM and RM confirmed the findings on October 1, 2025, at approximately 4:30 P.M. D5781