Wnc Dermatological Associates, Pa

Summary Statement of Deficiencies 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 review of manufacturer's instructions and review of 2024 and 2025 patient dermatophyte test medium (DTM) culture logs 10/7/25, the laboratory failed to follow manufacturer's instructions for incubation and result interpretation. Findings: Review of the Hardy Diagnostics Dermatophyte Test Medium Instructions for Use revealed "... PROCEDURE ... Incubate media at room temperature (15-30 degrees C.), aerobically, for up to fourteen days. ... INTERPRETATION OF RESULTS ... Media should be examined daily for up to fourteen (14) days. ... LIMITATIONS ... False - positive reactions may result, if interpretations are made beyond 14 days of incubation. An alkaline reaction will eventually be produced by most non- dermatophytic fungi that are capable of growing on this medium. ..." Review of 2024 and 2025 patient DTM culture logs revealed 18 patient cultures performed 1/1/24 - 10 /7/25 were incubated longer than the manufacturer's specified 14 days. Examples: 1. Patient A - DTM set up 3/11/24, result reported 4/3/24 (23 days); 2. Patient B - DTM set up 5/17/24, result reported 7/24/24 (68 days); 3. Patient C - DTM set up 9/13/24, result reported 10/15/24 (32 days); 4. Patient D - DTM set up 11/12/24, notation on log stated "11/26 - allow 2 more weeks", result reported 12/11/24 (29 days); 5. Patient E - DTM set up 1/24/25, result reported 2/18/25 (25 days); 6. Patient F - DTM set up 7 /3/25, result reported 7/30/25 (27 days). 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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, review of laboratory's procedures, and interview with the laboratory director 3/23/21, the laboratory failed to discard KOH(potassium hydroxide) and Chlorazol Black fungal stain reagents that had exceeded their expiration dates. Findings: During tour of the laboratory at approximately 1:05pm 3/23 /21, the surveyor observed two bottles of KOH (lot # K15C13, expiration date: 12/31 /18) and one bottle of Chlorazol Black( lot # K19C91, expiration date: 12/31/20) located by the microscope, that were available for use. The laboratory's procedure, Quality Assurance Program under Quality control states, "All test materials(KOH, saline, etc) are stored as directed by the manufacturer. All outdated materials are discarded." At approximately 1:15pm, the laboratory director confirmed the KOH and Chlorazol Black reagents were expired. He stated the laboratory does not perform the testing very often and they had not realized the reagents were expired. 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 --