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 the surveyor's review of Laboratory Personnel Report (CMS 209), the policies, procedures, records, and an interview with the laboratory staff, the laboratory failed to establish written policies and procedures that meet the personnel requirements in subpart M to assess employees performing Histopathology processing, affecting 4 out of 4 testing personnel (TP). Findings: 1. The CMS 209 lists 4 TP performing Histopathology tissue grossing and processing (a high complexity procedure) in the laboratory. 2. The laboratory's established competency policy and step-by-step procedure does not include the following personnel assessment requirements: 1). Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and 2). Assessment of problem solving skills. 3. On an Initial survey conducted on February 9, 2018 at 11:35 AM, the laboratory staff confirmed the above findings. 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 --