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 staff interview, the laboratory failed to establish policies and procedures to assess competency for the regulatory responsibilities of the clinical consultant (CC) and the technical consultant (TC) in the specialty of hematology. Findings include: 1. Record review on 06/20/2025 of the personnel competency files revealed the lack of competency assessment documentation for the regulatory positions of CC and TC. 2. Staff interview on 06/20/2025 at 9:30 AM with the TC confirmed the above finding. The TC further commented that he/she was unaware of the regulatory requirement for competency assessment for the CC and TC positions. 3. The laboratory performs 106 erythrocyte sedimentation rate tests annually in the specialty of hematology. 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 --