Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on 05/21/2026. The laboratory was found to be in compliance with condition level deficiencies. The following standard-level deficiencies were cited. D6052 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(vi) (b)(8)(vi) Assessment of problem-solving skills; and This STANDARD is not met as evidenced by: Based on review of laboratory's personnel Competency Assessment Form, Testing Personnel (TP) competency records and an interview with Testing Personnel #1 (TP1), the Technical Consultant (TC) failed to ensure that evaluations for testing personnel included assessment of problem-solving skills for moderate complexity testing for 7 or 7 TP. 1. A review of the laboratory's personnel Competency Assessment Form used for TP identified the following 5 elements used to evaluate competency for use of the Hemochron Signature Elite and AVOXimeter 1000e instruments used for patient sample testing: a. Specimen processing, oriented b. Quality Control, performance and evaluation c. Maintenance of instrument according to schedule d. Direct observation of test performance e. Accurately records & reports test results 2. A review of TP competency assessment records identified the following TP, which the described standardized Competency Assessment Form was used: TP1: Initial and 6-month assessment completed TP2: Initial and 6-month assessment completed TP3: Initial and 6-month assessment completed TP4: Initial and 6-month assessment completed TP5: Initial assessment completed TP6: Initial assessment completed TP7: Initial and 6-month assessment completed 3. In an interview on 05/21 /2026 at 11:30 AM, TP1 confirmed the findings stated above. 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 --