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 a review of the quality assessment (QA) plan, competency assessment records, and staff interview, the laboratory failed in 2016, 2017, and 2018 to assess the competency of two of two testing personnel who perform the gross description of tissues in the pathology laboratory. Findings include: a. Two histotechnologists (#13 and #14 on Form CMS-209) perform the gross description of tissues in the pathology laboratory. b. The QA plan states, "The Director will evaluate each step of the testing process and determine if the personnel is able to perform the test(s) appropriately and report results accurately." c. No documentation existed to show that the two histotechnologists had been assessed in 2016, 2017, or 2018 for competency in the grossing of tissues. d. Staff stated that they were unaware that the gross description of tissue is considered a high complexity CLIA test, and confirmed that the histotechnologists had never been assessed for competency as required by the federal CLIA regulations. 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 --