Summary:
Summary Statement of Deficiencies D0000 A revisit was conducted on 04/02/2025 at Dermatologists of Southwest Ohio 36D1099555 for all previous deficiencies cited on 03/19/2025. All deficiencies have been corrected and no new noncompliance was identified. The laboratory is in compliance with the Conditions of Participation at 42 CFR Part 493, Laboratory Requirements. D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; and This STANDARD is not met as evidenced by: Based on record review and an interview with the Practice Manager, the laboratory failed to enroll in a proficiency testing (PT) program for the subspecialties of Mycology and Parasitology. This deficient practice had the potential to affect 11 out of 11 patients tested under the subspecialty of Mycology and one out of one patient tested under the subspecialty of Parasitology from 01/01/2025 through 03/19/2025. Findings Include: 1. Review of the "Scabies and KOH PPM Competency Assessment and Test Accuracy Verification Policy and Procedure," signed and dated by the Laboratory Director on 01/31/2018, failed to find policies and procedures for enrollment in a PT program for the subspecialties of Mycology and Parasitology. 2. The inspector requested the 2025 PT records for the subspecialties of Mycology and Parasitology from the Practice Manager. 3. The Practice Manager confirmed the laboratory was not enrolled with an HHS approved PT provider for the subspecialties of Mycology and Parasitology and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 03/19/2025 at 1:47 PM. 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 --