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 the written personnel policy, lack of documentation and interview with testing personnel #2, the laboratory failed to follow the policy for conducting personnel competency evaluations for 20 of 20 testing personnel for 2017 and to date August 7, 2018. Findings: 1. The written personnel policy states, " All personnel trained to perform the troponin test must complete a competency test every twelve months - semiannually during the first year that the person tests samples and annually thereafter. The competency must be conducted by the technical consultant." 2. The laboratory did not have documentation to show that a qualified technical consultant conducted competency evaluations for 20 testing personnel during 2017 and to date August 7, 2018. 3. Interview with testing personnel # 2 on August 7, 2018 at 10:30 AM confirmed the laboratory failed to follow written policies for evaluating the competency of testing personnel performing moderate complexity troponin testing. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with testing personnel # 2 on Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- August 7, 2018 at 10:30 AM confirmed, the current laboratory director failed to approve, sign and date the troponin test procedure and the laboratory's individualized quality control plan (IQCP). D5785