Summary:
Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 review of procedure, patient logs, and cryostat temperature records and interview with the office administrator, the laboratory failed to ensure the cryostat temperature was maintained as required for 30 of 105 testing days. Findings: 1. Review of "MOHS Calibration" procedure states "Each day that cases are performed using the cryostat, the temperature will be verified to be within range of -20 to -30 degrees Celsius". 2. Review of 2024 and 2025 "MOHS Patient Monitoring Log" shows 105 testing days. 3. Review of cryostat temperature records shows that the Advantik QS12 cryostat temperature was out of range 30 of 105 testing days from January 2024 to December 2025. 4. Interview with the office administrator on January 7, 2026 at 9:00 AM confirmed the laboratory failed to ensure the cryostat temperature was maintained as required for 30 of 105 testing days in 2024 and 2025. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control 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 -- materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, patient logs, lack of stain quality records and interview with the office administrator, the laboratory failed to document the quality of staining materials each day of use for hematoxylin and eosin (H&E) stains in 2024 and 2025. Findings: 1. Review of laboratory procedure "MOHS Comprehensive Quality Assurance Program" states "Specimens are received on a daily basis and consist of hematoxylin and eosin stained slides and special stains with controls including (PAS, GMS, AFB, alcian blue, immunohistochemical stained sections). The slide quality is checked in the histology laboratory before they are sent to dermatopathology for interpretation. The slides with controls are also reviewed for staining quality and accuracy and any problems are to be documented on a daily basis in the quality assurance log book". 2. Review of 2024 and 2025 "MOHS Patient Monitoring Log" shows approximately 763 patient results were reported. 3. Lack of stain quality records showed the laboratory failed to document the quality of staining materials each day of use for H&E stains for 2024 and 2025. 4. Interview with office administrator on January 7, 2026 at 9:15 AM confirmed the laboratory failed to document the quality of the staining materials each day of use. -- 2 of 2 --