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: Item I: Based on record review and an interview with Technical Supervisor (TS) #2, the laboratory failed to establish and follow written policies and procedures to assess the competency of the TS based on the responsibilities of the position and at a frequency determined by the laboratory. This deficient practice had the potential to affect 1,033,738 patients tested under the specialties of Microbiology, Diagnostic Immunology, Chemistry, and Hematology. Findings Include: 1. Review of the laboratory's Form CMS-209 on 11/27/2023, approved by the Laboratory Director (LD) on 11/22/2023, revealed two individuals listed and qualified by the Laboratory Director to function as a TS. 2. Review of the laboratory's "Competency and Training of Laboratory Personnel" policy and procedure, signed and dated by the Laboratory Director on 06/21/2021 found no mention of instructions for assessing the TS competency. 3. The Inspector requested a TS competency assessment policy and procedure, and competency assessment documentation for each TS based on the responsibilities of the position. TS #2 confirmed the laboratory did not have a TS competency assessment policy and procedure, did not perform a TS competency assessment for TS #2, and was unable to provide the requested information. The interview occurred on 11/27/2023 at 2:41 PM. Item II: Based on record review and an interview with Technical Supervisor (TS) #2, the laboratory failed to establish and follow written policies and procedures to assess the competency of the General Supervisor (GS) based on the responsibilities of the position and at a frequency determined by the laboratory. This deficient practice had the potential to affect 1,033,738 patients tested under the specialties of Microbiology, Diagnostic 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 -- Immunology, Chemistry, and Hematology. This deficient practice affected five out of five (100%) of the individuals listed as a GS. Findings Include: 1. Review of the laboratory's Form CMS-209 on 11/27/2023, approved by the Laboratory Director on 11/22/2023, revealed five individuals listed and qualified by the Laboratory Director to function as a GS. 2. Review of the laboratory's "Competency and Training of Laboratory Personnel" policy and procedure, signed and dated by the Laboratory Director on 06/21/2021 found no mention of instructions for assessing GS competency. 3. The Inspector requested a GS competency assessment policy and procedure, and competency assessment documentation based on the responsibilities of the position. TS #2 confirmed the laboratory did not have a GS competency assessment policy and procedure, did not perform GS competency assessments for all five individuals listed as a GS, and was unable to provide the requested information. The interview occurred on 11/27/2023 at 2:41 PM. -- 2 of 2 --