Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor observation, review of manufacturer's instructions, laboratory policy, Daily Maintenance Logs in 2024 and 2025, and confirmed in interview, the laboratory failed to follow manufacturer's instructions for weekly maintenance on the Leica Cryostat for 17 weeks in 2024 and 11 weeks in 2025. Findings included: 1. During a tour of the facility on 03/24/2025 at 3:10 PM, the surveyor observed a Leica CM1850 tissue processors in the laboratory available for patient specimen processing. (Serial Number: 0690) 2. Review of manufacturer's instructions for the Leica CM1850 Cryostat (V2.2) revealed the following: " ...9.3.1 General Maintenance ... Once a week: Apply a drop of oil to the plastic coupling. Lubricate the specimen cylinder." 3. Review of the laboratory's, "Daily Maintenance Log" in 2024 and 2025, revealed the laboratory failed to document weekly maintenance on the cryostat. The laboratory was asked to provide documentation of performing weekly maintenance on the Leica Cryostat in 2024 and 2025. No documentation was provided. 4. In an interview on 03/24/25 at 02:32 PM in the facility break room, Testing Person 1 (TP1), confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (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 surveyor observation, review of manufacturer's instructions, Daily Maintenance Logs in 2024 and 2025, and confirmed in interview, the laboratory failed to follow manufacturer's instructions for acceptable humidity range prior to patient testing for 38 of 38 patient test days in 2024 and 2025. Findings included: 1. During a tour of the facility on 03/24/2025 at 3:10 PM, the surveyor observed one Leica CM1850 tissue processor in the laboratory available for patient specimen processing. (Serial Number: 0690) 2. Review of manufacturer's instructions for the Leica CM1850 Cryostat (V2.2) revealed the following: " ...Operating Specifications: ... Humidity: Less than 60% Relative Humidity" 3. Review of the laboratory's, "Daily Maintenance Log" in 2024 and 2025, revealed the laboratory failed to document humidity in the laboratory. The laboratory was asked to provide documentation of humidity in the laboratory prior to patient testing in 2024 and 2025. No documentation was provided. Further review revealed the following patient test days in 2024 and 2025 when the laboratory failed to document humidity prior to testing: Dates in 2024 09/09/24 09/16/24 09/23/24 09/30/24 10/07/24 10/14/24 10/21/24 10/28 /24 11/04/24 11/11/24 11/18/24 11/26/24 12/2/24 12/03/24 12/09/24 12/10/24 12/16 /24 12/23/24 12/24/24 12/30/24 Dates in 2025 01/06/25 01/13/25 01/14/25 01/20//25 01/28/25 02/03/25 02/04/25 02/05/25 02/10/25 02/11/25 02/17//25 02/18/25 02/24/25 02/25/25 03/03/25 03/04/25 03/10/25 03/11/25 03/17/25 03/24/25 4. In an interview on 03/24/25 at 02:15 PM in the facility break room, the facility manager confirmed the above findings. 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 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 policy, manufacturer's instructions, Daily Maintenance Logs in 2024 and 2025, and confirmed in interview, the laboratory failed to document predicted staining characteristics for Hematoxylin and Eosin (H&E) frozen tissues daily control slides for 38 of 38 patient testing days in 2024 and 2025. Findings included: 1. Review of laboratory policy, "Lockhart Matter Dermatology-Plano MOHS Lab Policy and Procedure" (Reviewed by the laboratory director on 03/04 /2025) revealed the following: "Control Slide The Mohs surgeon will examine a control slide ...to determine if stain quality is acceptable. If staining quality does not meet the surgeon's standards, the stains are replaced or changed as needed, and a Request of