Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on April 18, 2024. Group M Dermatology PA dba Jupiter Dermatology & Hair Restoration 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 review of patient accession logs, peer review records, and the Laboratory Personnel Report; and interview, the laboratory failed to document the verification of accuracy for Potassium Hydroxide (KOH) and Scabies at least twice annually for 2022 and 2023. Findings: Review of the patient accession log for KOH and Scabies revealed the laboratory had tested 66 patients in 2022 and 131 patients in 2023 for KOH and Scabies. Review of peer review records revealed there were no records or peer review done for KOH and Scabies. Review of the Laboratory Personnel Report, signed by the Laboratory Director on 04/18/2024, listed two Testing Personnel (A, B) who performed testing for KOH and Scabies. On 04/18/2024 at 11:30 AM, the Laboratory Director stated he (Testing Personnel A) and Testing Personnel B reviewed each others cases but failed to document it. 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 --