Brandon Dermatology Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Brandon Dermatology PA on 05/07/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Practice Administrator, the laboratory failed to perform competency assessments two out of two years reviewed (2018 - 2019) on one of one Clinical Consultant/Technical Supervisor/ General Supervisor /Testing Person. Findings Included: Review of the CMS-209 Laboratory Personnel Report dated 05/07/20 revealed the laboratory has one Clinical Consultant who also serves as the Technical Supervisor, General Supervisor and the Testing Person. A review of this employee's record revealed no documentation of competency assessments. Review of the "Laboratory Director Job Description and Duties" procedure showed that one of the duties was to "Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to verify that they maintain competency." On 05/07 /20 at 11:20 am, the Practice Administrator confirmed that the laboratory did not have competency evaluations for the Clinical Consultant/Technical Supervisor/General Supervisor/Testing Person. 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 D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on procedure manual and laboratory logs record review and interview with the Practice Administrator, the Laboratory Director failed to have a Quality Assurance procedure. Findings included: During the procedure manual record review, it was discovered the procedure manual did not include a Quality Assurance procedure. During the record review of the laboratory's logs, it was found that documentation of quality assurance activities was missing from the laboratory's records. During an interview on 05/15/2018 at 1:00 p.m, the Practice Administrator confirmed that the laboratory did not have a Quality Assurance procedure. 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 --