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, the laboratory failed to establish a policy to assess technical consultant competency and perform annual competency in 2021 for one (SP#2) out of two technical consultants. Findings Included: 1) Review of the CMS-209 "Laboratory Personnel Report", signed by the laboratory director on 10/18 /2022, revealed SP#2 is a technical consultant over Mycology, Parasitology and Hematology. 2.) Review of "Proficiency Testing, Competency Evaluation and Training" policy, no signature by laboratory director, stated "Competency Evaluation of Personnel: The CLIA legislation requires a mechanism to evaluate competency in test performance for each person who performs a Clinical diagnostic test." The policy did not require competency assessment for technical consultants. The policy also failed to include how competency will be performed on a technical consultant. Review of 2021 Lab Testing Competency Annual records revealed no competency assessment for TC#2 in 2021. 3.) Review of 2021 "Laboratory Testing Competency Annual" records revealed no technical consultant competency assessment for SP#2 in 2021. 4.) During interview on 10/24/2022 at 3:22 PM, SP#2 confirmed the laboratory failed to create a policy for technical consultant competency assessments and no technical consultant competency assessment was completed for SP#2 in 2021. 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 --