Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 02/26/2020 found that South Florida Institute for Reproductive Medicine clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 staff interview, the laboratory failed to have the annual competency assessment for 1 out of 1 Technical Supervisor (TS) signed by the laboratory director and for 1 out of 1 General Supervisor (GS) signed by the TS for 2019. Findings include: 1)Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 02/21/2020 revealed that: -The Laboratory Director and Clinical Consultant was the same person, 1 TS, 1 GS and 4 testing personnel (A, B, C, D). - GS was Testing personnel (TP) A. 2) Review of TS and GS annual competency assessment for 2019 revealed that a person not listed on CMS form 209 signed both evaluations. During an interview on 02/26/202 at 11:00 AM, with GS, she confirmed that a person not listed on form 209 signed the annual competencies assessment listed above. 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 --