Summary:
Summary Statement of 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 review of testing personnel (TP) records and discussion with the Laboratory Director (LD) who also acts as the Technical Consultant (TC), the laboratory failed to perform annual competency assessment of TP for moderate complexity testing in Chemistry and Hematology. Findings include: 1. Upon review of TP records, no competency assessments for moderate complexity testing in either Chemistry or Hematology could be found for the two (2) current TP. 2. During an interview with the LD/TC on 12/10 at approximately 12:30 p.m., she confirmed that competency assessment for Chemistry and Hematology assays of the two (2) TP had not occured for 2017 or 2018. 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 --