Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on January 29, 2026 with the following standard level deficiencies cited. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Form 209, laboratory policies and procedures, and interview with the Testing Personnel (TP), the laboratory failed to have an established written policy and procedure to assess testing personnel and consultant competency for two of two years. Findings Included: 1. Review of the CMS Form 209 submitted revealed one TP and one Technical Supervisor (TS) listed for the laboratory. 2. Review of the laboratory's policy titled 'Dermatology and Skin Cancer Surgery Center-Staff Qualifications and Training' stated the following: "The Laboratory shall ensure that all personnel performing MMS (Mohs Micrographic Surgery) and related laboratory services possess appropriate qualifications, training, and experience as required ...". The policy did not include elements including procedures on staff competencies, how to perform competencies, and frequencies. 3. In an interview on January 29, 2026 at 9:17 AM in the laboratory, the TP confirmed the policy was approved and signed in January 2026, but did not include procedural elements related to competency for testing personnel and consultants. 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 4 -- (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 direct observation, manufacturer instructions, laboratory policy and procedures, temperature records, and interview with the Testing Personnel (TP), the laboratory failed to define an acceptable temperature range for the Leica CM 1510 S Cryostat machine in accordance with manufacturer instructions for three of three months (Random Review October 2025 to December 2025). Findings Included: 1. During a laboratory tour at 8:50 AM, one Leica CM 1510 S Cryostat machine (Serial Number 043638460) was observed in use within the laboratory. 2. Review of the manufacturer's instructions titled 'Leica Microsystems Leica CM1510 S Cryostat Instructions Manual V1.4' stated the following temperature range requirements on page 33 of 56: "Skin with fat (-35 to -25 degrees Celsius). Skin without fat (-25 to -15 degrees Celsius)." 3. Review of the laboratory's policy titled 'Dermatology and Skin Cancer Surgery Center Quality Control' stated the following: "Principle Quality control activities are utilized to evaluate the uniformity of specific processes and basic functions to assure that they operate within acceptable parameters. The process include accessioning, processing, interpretation, reporting, and storage of submitted specimens. Quality control activities involve: Maintaining adequate lighting, water and drainage, and air conditioning in the laboratory. Routine checking and maintenance of cryostat. Maintaining temperature record of cryostat (-20 Celsius to -25 Celsius) ..." 4. Review of the laboratory's temperature records ranging from October 2025 to December 2025, titled 'Dermatology and Skin Cancer Surgery Center Mohs Equipment Check Log Lake Mary', revealed an acceptable temperature range of -26 to -22 degrees Celsius. 5. In an interview on January 29, 2026 at 9:43 AM in the laboratory, the TP confirmed the that the laboratory tested samples of skin with and without fat, and the acceptable temperature range was not defined in accordance with the manufacturer's instructions nor the laboratory's policy. D5781