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 with the mohs technician, the laboratory failed to follow its competency assessment policy for assessing testing personnel competency for two (testing personnel #1 and #2) of two testing personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's patient testing logs showed the laboratory started its mohs surgery histopathology testing in September 2024. 2. A review of the laboratory's Form CMS-209 showed two testing personnel, testing personnel #1 and #2, had been listed as testing personnel at the current survey and the previous survey on 4/22/25. 3. A review of the laboratory's "PROFICIENCY TESTING Competency and CLIA competency assessment" policy revealed a section stating, "Evaluation and documenting competency of personnel responsible for testing is required at least semiannually during the first year the indivudual sees patient specimens. After the first year, competency assessment must be performed at least annually." The policy goes on to state, "The following procedures are requirements for assessment of competency for all personnel performing laboratory testing. 1. Direct observations of routine patient test performance, including preparation, if applicable, specimen handling, processing and testing. 2. Monitoring the recording and reporting of test results. 3. Review of intermediate test results, and preventive maintenance records. 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through testing previously testing samples [sic]. 6. Assessment of problem solving skills." 4. The surveyor requested documentation of competency assessments for testing personnel #1 and #2 on 8/20/26 at 2:20 pm and it was not provided. 5. An interview on 8/20/26 at 2:21 pm 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 -- with the mohs technician confirmed the laboratory did not have competency assessment documentation in accordance with its policy for testing personnel #1 and #2. -- 2 of 2 --