Summary:
Summary Statement of Deficiencies D0000 A revisit was conducted on 05/07/2025 at Integrated Dermatology of Columbus, LLC. 36D0686623 for all previous deficiencies cited on 04/22/2025. 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. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and an interview with the Clinical Consultant (CC), the laboratory failed to enroll in a proficiency testing (PT) program for the subspecialty of Mycology. This deficient practice had the potential to affect eight out of eight patients tested under the subspecialty of Mycology from 01/01/2025 through 04/22/2025. Findings Include: 1. The laboratory failed to enroll in a PT program for the subspecialty of Mycology. (Refer to D2001) D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which 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 -- 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 Clinical Consultant (CC), the laboratory failed to enroll in a proficiency testing (PT) program for the subspecialty of Mycology. This deficient practice had the potential to affect eight out of eight patients tested under the subspecialty of Mycology from 01/01/2025 through 04/22/2025. Findings Include: 1. Review of the "Lab Manual" signed and dated by the Laboratory Director on 01/30/2025, failed to find policies and procedures for enrollment in a PT program for the subspecialty of Mycology. 2. The inspector requested the 2025 PT records for the subspecialty of Mycology from the CC. 3. The CC confirmed the laboratory was not enrolled with an HHS approved PT provider for the subspecialty of Mycology and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 04/22/2025 at 1:59 PM. -- 2 of 2 --