Palm Harbor Dermatology Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palm Harbor Dermatology PA on 07/22/20. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Medical Laboratory Evaluation (MLE) proficiency testing and interview with Licensed Practical Nurse (LPN), the Laboratory Director failed to document the review of the proficiency testing for 1 ( 1st event in 2020 ) out of 4 (1st, 2nd, and 3rd testing events in 2019 and 1st event in 2020 ) testing events reviewed. Findings Included: Review of MLE proficiency testing records for the 2020 1st testing event revealed that the Laboratory Director did not have documentation that the results were reviewed. Interview on 007/22/20 at 01:10 PM with the LPN confirmed that the MLE 2020 1st event proficiency testing did not have Laboratory Director documentation of results reviewed. 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 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 lack of employee competency documentation, a review of the CMS 209 and the laboratory procedure manual, and interview with Testing Personnel #B, the laboratory failed to document competency evaluations on 1 of 2 (#B) Testing Persons for 2 of 2 (2016-2018) years reviewed. Findings Included: A review of the CMS 209 Form titled Laboratory Personnel Report signed by the laboratory director and dated 7 /26/18 revealed Employee #B was a Testing Personnel. Employee competency evaluations of Testing Person #B were requested and no competencies were provided. Review of the laboratory procedure manual revealed a competency assessment procedure was in place. Interview on 08/01/2018 at 10:00 AM with Testing Personnel #B revealed she performed histology grossing and the doctor does observe her, but no documentation of competency evaluations had been completed. 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 --