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 documents presented during Certificate of Compliance survey 10/14/2025 and interview with the Technical Supervisor (TS) also the Technical Consultant (TC) for this lab, the Laboratory failed to ensure the laboratory had a policy / procedure in place that speaks to the assessment of laboratory personnel who serve as TC's, TS's, Clinical consultants(CC's) and General Supervisors (GS). Findings include: 1. Review of the approved procedures in place, there was no evidence of a procedure describing the process the lab has in place to assess competency of it's federally recognized positions of TC's, TS's, CC's or GS's and how often assessment will be performed. 2. The CMS form 209 Personnel Report submitted during survey indicates that there are four (4) testing personnel (TP). Two (2) of them are Medical Laboratory Scientist's (MLS's), both listed on the CMS form 209 as a TC (Chemistry, Toxicology, Mycology, Parasitology, Endocrinology, Immunology (General and Syphilis) and Virology) and as a TS (Hematology). One (1) of the two (2) is listed as a GS (TS #2 and GS #1 Hematology). 3. Request for competency assessment of the federal duties assigned to each of these personnel listed as a TC, TS, CC, or GS by the Laboratory Director (LD) could not be produced. 4. TS #1 confirmed during interview 10/14/2025 at 2:00 pm the she was not able to produce competency assessments by the LD for the federally named positions on the CMS form 209 Personnel Report submitted 10/14/2025 or a procedure describing the responsibilities of those with federal titles TC, TS, CC, GS and the frequency of these competency assessments. 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 --