Summary:
Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 6/2/26. The Rushmore Dermatology LLP laboratory was found not in compliance. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to verify and document the accuracy for one of three test methods reviewed (periodic acid-schiff [PAS-F] fungal stain) twice a year for the last 24 months (May 2024 through May 2026). This verification would have ensured the accuracy of the examination of patient specimens for the presence of fungal elements. Findings include: 1. Observation on 6/2/26 at 10:30 a.m. revealed the following reagents were available for use to stain patient specimen slides with PAS-F stain for the presence of fungal elements: Schiff's Reagent - lot #161775, expiration date 6/12/26; Periodic Acid Solution 0.5% - lot # 15185, expiration date 6/18/26, bottle approximately 1/4 full; Light Green stain solution - lot # 228704, expiration date 7/31/26, bottle approximately 1/4/ full. Review on 6/2/26 of the laboratory's KOH (potassium hydroxide)/Stain verification of accuracy reports revealed there was no documentation the accuracy of the PAS-F test method was verified twice a year for the time frame above. No other documentation of a verification for accuracy was available for review. Review of the laboratory test count form revealed eighty-two patient PAS-F specimens were processed and reported in 2025 without verification of the test method's accuracy. Interview on 6/2/26 at 9:50 a.m. with laboratory personnel A revealed the laboratory received patient skin and nail specimens; processed the specimens; and, stained the specimen slides with PAS-F stain for the healthcare 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 -- provider to examine for the presence of fungal elements. The slides were then returned to the laboratory for storage after examination. The twice-yearly verification of accuracy for the PAS-F test method was not completed by any of the healthcare providers examining the patient PAS-F stained slides in the seven years she was employed in the laboratory. -- 2 of 2 --