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 a surveyor's review of the laboratory policies/procedures, annual competency records and an interview with the office administrator, the laboratory failed to have a complete policy and procedure for personnel competency and perform annual competency. Finding Include: 1) It was confirmed by the office administrator on March 30, 2018, at approximately 11:00 am that the laboratory failed to have a complete written procedure for annual competency to include direct observation for two of three testing personnel. 2) The laboratory failed to perform annual competency for one of three testing personnel in the calendar years 2016 and 2017. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the laboratory's records and an interview with the office administrator, the laboratory director failed to ensure that the annual competency review included direct observation for two of three testing personnel and annual competency for one of three testing personnel. Refer to D5209 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 --