Dermatology Group Pa,The

Summary Statement of Deficiencies D0000 Recertification survey was conducted on December 3, 2021. The Dermatology Group 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 interview, the laboratory failed to verify the accuracy of Mycology and Parasitology testing at least twice annually for 1 (2021) out of 2 years reviewed (2020, 2021) for 6 (A - F) of 7 moderate complexity Testing Personnel (A - G). Findings: Review of proficiency testing found no peer reviews for Mycology and Parasitology for 2020. Review of the policy titled "Mycology and Parasitology - KOH and Scabies" noted peer review will be done biannually, and the Laboratory Director will evaluate test reports to determine the same interpretation was made by each provider (testing personnel). On 12/03/2021 at 1:35 PM, the Site Manager stated peer review for Mycology and Parasitology was not done in 2020. 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 D0000 A Recertification survey was conducted on September 10, 2019. The Dermatology Group PA clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document competency assessment on 7 out of 7 moderate complexity Testing Personnel from September 2017 to September 2019 (A, B, C, D, E, F & G). Findings: Review of the annual competency records showed that the laboratory failed to have documentation of competency assessments for the moderate complexity Testing Personnel performing the KOH (potassium hydroxide preparation) and Scabies testing. During an interview on 9/27/19 at 11:12 PM, the Practice Administrator acknowledged that they had not performed competencies on the moderate complexity testing personnel performing the KOH and Scabies 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 1 --