Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/08/2019 found that the Uhealth Electron Microscopy Laboratory clinical laboratory is 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 interview with staff, the laboratory failed to perform initial and semiannual competency assessment for the general supervisor (GS), during 1 out of 2 years reviewed. Findings include: 1) Review of CMS form 209, Laboratory Personnel Report dated and signed by the Laboratory Director on 9/23/2019 revealed that: -The Laboratory Director, Clinical Consultant and Technical Supervisor was the same person. -Testing personnel (TP) # A and # B. -TP# B was also listed as General Supervisor (GS). 2) Review of personnel files revealed that the GS started on 10/12 /2018 in that position. There was no initial and 6 months assessment documented for the GS. During an interview on 10/08/2019 at 11:00 AM, with the UM Quality staff confirmed that there was no documentation of the initial and semiannual competency assessment for the GS for the period of reference. 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 --