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 lack of documentation and interview with the technical consultant (TC) on June 10, 2021, as specified in the personnel requirements in subpart M, the laboratory failed to establish and follow written policies and procedures to assess all testing personnel competency. Findings include: 1. The laboratory had two (2) testing personnel (TP). 2. One (1) out of two (2) of the (TP) listed on the CMS-209 Form, did not have any documentation of training or competency for the tests performed at the laboratory. The second TP had an inclomplete competency for 2019 with missing signatures and no competency evaluation for 2020. 3. This deficient practice was affirmed by interview with the TC on June 10, 2021at approximately 12:50 p.m. 4. The laboratory reportedly performs approximately 4,810 tests annually. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of