Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 3/4/20 at Dermatology Associates of the Palm Beaches PLLC, a clinical laboratory in Atlantis, Florida. Dermatology Associates of the Palm Beaches PLLC is not in compliance with 42 Code of Federal Regulations (CFR), Part 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 with laboratory personnel, the laboratory did not do verification of potassium hydroxide (KOH) preps twice annually. The findings included: Review of proficiency testing records on 3/4/20 revealed that perr review verifications of KOH preps were performed on 1/2017 and 3/2020. During an interview with testing person B at 11:15 a.m. on 3/4/20, she confirmed that those were the only verifications done for KOH prepes. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and staff interview with laboratory personnel, the technical consultant did not document performance evaluations for three of three 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 -- personnel that performed moderate complexity testing. The findings included: Review of personnel records on 3/4/20 revealed that there were no competency evaluations of testing personnel for the past two years. During an interview with testing person B at 11:15 a.m. on 3/4/20, she confirmed that she was not aware of documented competency evaluations of teting personnel. -- 2 of 2 --