Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 1st, 2024. Simona B Bartos DO. PA., clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and staff interview, the laboratory failed to verify the accuracy of Histopathology testing for 1 (Testing Person #2) out of 4 Testing Personnel (TP) reviewed from July 2023 to September 2024. Findings included: 1. Personnel records reviewed revealed that in the Histopathology section there are four (4) Testing Person (Laboratory Director TP1, mohs surgeon TP2, TP3, and TP4) as per CMS 209 Form. 2. Review of Subpart I, 42 CFR Part 493.901 through 493.959 revealed that there was no approved proficiency testing programs for the interpretation of stained tissues. 3. Review of the Quality Assurance (QA) peer review found that peer review for Histopathology was only done for the laboratory director. The laboratory did not provide Histopathology peer review record for TP2. 4. During interview on 10/01/2024 at 3:30 PM, the Office Manager admitted to not having QA peer review performed on TP2. 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 --