Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 7/15/21 at Ameripath Florida LLC, a clinical laboratory in Fort Myers, Florida. Ameripath Florida LLC is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. . 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 CMS 209, competency records and procedure manual record review, and interview by electronic correspondence (email) with the Laboratory Manager, the laboratory failed to have documentation of competency assessment for the subspecialties of histopathology for 2 out of 2 years reviewed (2019-2021) for Testing Personnel B. The findings included: Review of the "Policy for Performance Assessment of Delegated Duties" procedure on page 5 of 13 revealed that, "In addition to assessment of delegated duties, Clinical Consultants, Technical Consultants, Technical Supervisors, and General Supervisors who perform testing on patient specimens must also have competency assessment on each test system and it must include all six required elements." Review of the CMS 209 signed by the Laboratory Director on 7/13/21 revealed the laboratory had two Testing Personnel: Testing Person #A (who is also the Laboratory Director) and Testing Person #B. Review of Testing Person #B's personnel file revealed that competency assessments had not been performed for 2 out of 2 years (2019-2021). Interview by email on 7/15 /21 at 1:31 p.m., the Laboratory Manager stated in the past the peer review had been acceptable to demonstrate competency. 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 --