Summary:
Summary Statement of Deficiencies D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: _ Based on record review of employee qualification and training documentation and interview with Director of Operations, the laboratory failed to provide documentation of laboratory training prior to analyzing patient specimens for 2 of 2 employees who qualify as testing personnel (TP) by earning a high school diploma. _ Findings include: 1. Document review of employee qualification and training documentation failed to produce documentation that appropriate laboratory training was performed prior to analyzing patient specimens for 2 of 2 employees who qualify as TP by earning a high school diploma. 2. Interview with the Director of Operations on 10/29 /2025 at approximately 11:35 AM confirmed TP did not have documentation of appropriate laboratory training prior to analyzing patient specimens. 3. The laboratory performs approximately 5,148 endocrinology tests a year. 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 --