Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted at Mens Wellness Centers on 7/31 /2019. The 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 Laboratory Director (LD), the laboratory failed to perform the six months competency assessment during the first year of employment for 3 out of 3 (TP# A, TP # B, TP # C) testing personnel (TP) in 2018. Findings include: Review of employee documentation showed that the laboratory failed to complete the 6th month evaluation for 3 (TP # A, TP # B and TP#C) out of 3 testing personnel for the year 2018. During an interview on 07/31/2019 at 1:30 PM, with the LD, he confirmed that there was no semiannual competency assessment documented for the period of the above- referenced for TP. 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 --