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 record review and interview with laboratory personnel, the laboratory did not have a written policy in place for assessing employee competency. Findings include: The surveyor reviewed the laboratory procedure manual on 05/09/2019, and in the quality assurance policy it specified that one of the goals was to assure the adequacy and competency of the staff, but it did not specify how that would be accomplished or how frequently it would be conducted. The requirement is for testing personnel to be evaluated at 6 months initially and annually thereafter. During an interview with the testing person at 10:55 a.m. on 05/09/2019, she confirmed that she had not had an evaluation documented in 2018. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that a competency evaluation was performed on the testing person annually. Findings include: The surveyor reviewed personnel information on 05 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- /09/2019, and found that there was no documented competency evaluation for the testing person for 2018. During an interview with that testing person at 10:55 a.m. on 05/09/2019, she confirmed that an evaluation had not been done since the one in the file that was done in 2017. -- 2 of 2 --