Affiliated Dermatologist Sc

Summary Statement of Deficiencies 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 surveyor review of quality assurance procedures and records and interview with the Director of Operations (staff A) the laboratory did not have documentation showing twice annual verification of accuracy of dermatopathology diagnostic slide interpretations for one of four events in the last two years. Findings include: 1. Review of the "Quality Assessment regarding CLIA requirements histopathologic examination" procedure showed the laboratory used peer evaluation to meet the twice annual requirement of quality assessment. The procedure included, "Biannually five slides of cutaneous specimens will be selected at random by a designated staff member". 2. Review of available quality assurance records showed the laboratory performed peer review of dermatopathology diagnostic slide interpretations twice annually in 2023 and once in the second half of 2024. No records were available for the first half of 2024. 3. Interview with Staff A on February 12, 2025, at 10:15 AM confirmed records were not available for the quality assessment peer review in the first half of 2024 and the laboratory could not show their completion of the quality assessment process twice annually in 2024. 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 --

Summary Statement of Deficiencies D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on surveyor review of test reports in patients' electronic medical records (EMR) and interview with the Practice Manager, the laboratory had not retained a pathology report for one of three patient cases reviewed that physician A read. Findings include: 1. Review of three cases reported by physician A showed the pathology report for a sample taken from the right shin of patient 1 on December 2, 2020 was not retrievable from the EMR. 2. Interview with the Practice Manager (staff B) on June 4, 2021 at 9: 51 AM confirmed the manager could not find the pathology report for patient 1 from December 2, 2020 in the EMR. 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 --