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 Standard Operating Procedures (SOPs), personnel training records, competency evaluation documentation, as well as interview with the Laboratory Director (LD), the laboratory failed to follow written policies and procedures to assess employee competency. FINDINGS: 1. There was no documentation of initial and six-month competency assessment performance for one out of one Testing Personnel (TP) hired August 2025. 2. There was no documentation of annual competency performance for two out of two TP hired August 2020. 3. These were contrary to instructions indicated in the current, approved CLIA Procedure Manual SOP which indicate initial, six-month, and annual competency assessment performance for all personnel. 4. The LD confirmed the findings on March 12, 2026, at 1:30 P.M. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's SOPs, twice annual verification records, as well as interview with the LD, the laboratory failed to document Proficiency Testing (PT) evaluation and verification activities. FINDINGS: 1. There was no documentation of 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 -- twice annual PT performance in 2024 for three out of three TP. 2. There was no documentation of twice annual PT performance in 2025 for three out of four TP. 3. These are contrary to instructions indicated in the current, approved CLIA Procedure Manual SOP which indicate that TP PT evaluation and verification activities must be documented. 4. The LD confirmed the findings on March 12, 2026, at 1:30 P.M. -- 2 of 2 --