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 competency evaluation policy and lack of histotechnologist evaluation document and an interview with the histotechnologist, the laboratory director failed to follow their establish competency assessment policy and perform the initial training for the histotechnologist in the first year of testing. FINDINGS: The histotechnologist confirmed on November 16, 2021 at approximately 4:00 PM, the surveyor's findings that the laboratory failed to follow their written competency assessment policy. a. The laboratory has a specific form titled "Histotechnologist Evaluation" for recording the initial training for Moth's histotechnologist and/or Moth's processing person. b. The laboratory failed to perform and document the Moth's histotechnologist training, prior to performing patient testing. D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: 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 -- Based on surveyor's review of personnel records, competency assessment procedure and records and an interview with the Moth's histotechnologist, the laboratory director failed to ensure that appropriate training was documented for the new Moh's histotechnologist hired 05/20/2020 who perform high complexity Moth's surgery tissue processing and pathology grossing. Refer to D5209 -- 2 of 2 --