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 review of the laboratory's competency assessment records and interview with the Regional Clinic Manager (RCM) and Medical Assistant (MA), the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 2 technical consultant (TC) for their supervisory responsibilities performed in 2022 and 2023. Findings include: 1. The laboratory could not provide a competency assessment procedure to assess TC for their supervisory responsibilities. 2. On the day of the survey, 12/05/2023 at 01:49 pm, a review of laboratory's competency records revealed that the laboratory failed to perform a competency assessment for 1 of 2 TC (CMS 209 TC #2) for their supervisory responsibilities performed in 2022 and 2023. 3. The RCM and MA confirmed the findings above on 12/05/2023 at 02:45 pm. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the laboratory's competency assessment records and interview with the Regional Clinic Manager (RCM) and Medical Assistant (MA), the Technical 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 -- Consultant (TC) failed to evaluate the competency assessment for 1 of 8 Testing Personnel (TP) who performed moderate complexity testing in mycology in 2022. Findings include: 1. On the day of the survey, 12/05/2023 at 01:49 pm, a review of laboratory's competency records revealed that the laboratory failed to perform a competency assessment for 1 of 8 TP (CMS 209 TP #4) who performed Potassium hydroxide testing in mycology in 2022. 2. The laboratory performed 432 Mycology and Parasitology tests in 2022 (per CMS 116 total estimated annual test volume). 3. The RCM and MA confirmed the findings above on 12/05/2023 at 02:45 pm. -- 2 of 2 --