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 records review, lack of Quality Assessment (QA) documentation, and interview with the histotechnician (HT), the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in quality control (QC), proficiency testing (PT), training, quality assessment activities (QA), and record and slide retention for Mohs testing since February 2026. The findings include: 1. Review of maintenance logs and forms showed completion of daily quality control, stain quality control, temperature and reagent logs, case evaluation, peer review proficiency, analytical assessment, and competency forms for the Mohs procedures. 2. A request was made for the policies and procedures defining the processes for QC, PT, training, QA, and records and slide retention but were not available. 3. An interview with the HT 5/28 /26 at 11:00 AM confirmed there were no policies/procedures. 4. The laboratory reports performing 100 Mohs annually. 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 maintenance records, lack of maintenance logs for one (1) of three (3) instruments, lack of procedure/protocols for instrument maintenance, and interview with the histotechnician (HT), the laboratory failed to establish a maintenance protocols to ensure system performance for three (3) of three (3) instruments used for processing Mohs slides since testing began in February 2026. The findings include: 1. Review of Cryostat 1 (Leica CM 1510 S) and Cryostat 2 (Leica CM 1850) maintenance logs showed completion of cryostat instrument maintenance on the days testing was performed (2/9/26 and 4/24/26). 2. A request for maintenance logs for the Linistat Linear Stainer was made and were not available. 3. A request for the procedure/protocols describing the maintenance and function checks for Leica CM 1510S, Leica CM 1850, and Linistat Linear Stainer was made and no procedures were available. 4. An interview with the HT 5/28/26 at 11:00 AM confirmed there were no policies/procedures. 5. The laboratory reports performing 100 Mohs annually. -- 2 of 2 --