Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on June 19, 2024 at 8:00 a.m. by the Montana CLIA Certification Program. 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 record review of testing personnel files, policy, and an interview with the technical supervisor (TS) #2, the laboratory failed to follow their policy and assess the six required procedures in their competency assessment for 21 out of 25 testing personnel (TP) from June 19, 2022, to June 19, 2024. Findings: 1. A review of testing personnel (TP) annual competency records revealed the laboratory failed to follow their Laboratory Competency Assessment policy to include direct observations of routine patient test performance, monitoring the recording and reporting of test results, direct observation of performance of instrument maintenance and function checks, and assessment of problem solving skills as part of the competency assessment for 21 out of 25 testing personnel (TP5 - TP25) for the AmniSure Rupture of [fetal] Membranes (ROM) and the i-STAT cardiac troponin I. 2. A review of the test volume sheet received on June 19, 2024, at 8:00 AM revealed 12 ROM tests and 853 troponin tests were performed in the last 12 months. 3. An interview on June 19, 2024, at 8:425 a.m. with TS #2, confirmed the competency assessment forms failed to have all six requirements as part of 21 out of 25 testing personnel annual competencies from June 19, 2022, to June 19, 2024. 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 --