Cumberland Dermatology, Pc

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory and staff interviews, the laboratory failed to ensure that it did not use five of six lots of tissue marking dyes beyond their expiration dates for Mohs surgical patient testing in 2025 (5 of 5 months reviewed). The findings include: 1. Observation of the laboratory on 01/15/2026 at 09:00 a.m. revealed one grossing station used for gross examination of Mohs surgical tissue specimens. The station contained six different tissue-marking dyes. The following dyes had expired: Color Lot No Exp Date Blue 188140 12-31-2025 Green 176534 06-30-2025 Red 171349 04-30-2025 Orange 186726 11-30-2025 Black No lot or expiration indicated. 2. The laboratory director and Mohs technician confirmed the findings in an interview on 01/15/2026 at 11:00 a.m. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the PT records in 2016-17 and an interview with the lead histotech determined the laboratory director failed to ensure that all PT attestation statements are signed during 2017. The findings include: 1. Review of the 2017 events 1st-3rd PT records for the clinical microscopy photographs for the specialties of mycology and parasitology revealed the laboratory director did not sign the attestation statements for testing persons during the 1st and 3rd events of 2017. 2. Interview with the lead histotech on February 15, 2018, at approximately 10:50 AM confirmed that the director failed to attest/sign attestation statements for the 2017 PT events 1st-3rd. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 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 -- instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (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 a review of the equipment quality control -cryostat policy, maintenance temperature logs for 2016-17 and an interview with the lead histotech, the laboratory failed to take