Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palm Harbor Dermatology PA on 11/30/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Moh's Lead Technician, the laboratory failed to ensure the accuracy for twice a year testing for 1 (#B) out of 2 Testing Personnel (#A and #B) for 2019 and 2020 out of 2 years reviewed (2018- 2020). Findings included: Record review of the procedure "PT Requirements" revealed that the procedure stated "PPM testing sites need to verify the accuracy of their testing at least twice per year." Record review of the Quality Assurance (QA) Peer Review for Ectoparasites (scabies) for the subspecialty showed that Testing Personnel #B performed the peer review 5/13/2019 and 11/12/2018. On 11/30/2020 at 10:20 a.m., the Moh's Lead Technician stated she thought the peer review was only performed once a year. 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 --