Summary:
Summary Statement of Deficiencies D0000 A revisit was conducted on 04/21/2025 at OhioDerm Holdings, Inc. 36D2305956 for all previous deficiencies cited on 04/08/2025. 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. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) (e)(12) Ensure that prior to testing patients specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; This STANDARD is not met as evidenced by: Based on record review and an interview with the Practice Manager, the Laboratory Director failed to ensure that one out of one testing personnel (TP) had demonstrated they could perform all tissue grossing procedures reliably to provide and report accurate results prior to performing patient testing in the subspecialty of Histopathology. This deficient practice had the potential to affect 1212 out of 1212 patient tissue grossing procedures performed by one out of one TP from 01/08/2025 through 04/08/2025. Findings Include: 1. Review of the laboratory's Form CMS-209, signed and dated by the Laboratory Director on 02/11/2025, revealed one individual listed and credentialed as TP to conduct high complexity patient tissue grossing testing procedures. 2. Review of the laboratory's documentation, from beginning of testing on 01/08/2025 to the date of inspection 04/04/2025, failed to find documentation of initial training prior to patient testing for the sole TP. 3. The Inspector requested the laboratory's initial demonstration of competence documentation for the sole TP from the Practice Manager. The Practice Manager confirmed that the laboratory did not conduct and document initial demonstration of competence for the sole TP prior to independent patient tissue grossing testing 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 -- procedures performed and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 4/08/2025 at 2:08 PM. -- 2 of 2 --