Summary:
Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC) the laboratory failed to evaluate the competency of testing personnel at least annually for three of six testing personnel (Testing Personnel 1 [TP1], TP4, and TP5) who performed non-waived testing. . Findings include: 1. Review of the laboratory ' s personnel files was conducted to examine competency assessment records. The records evaluated were for the non-waived Abbott i-STAT Chem 8+ and the PixCell Complete Blood Count (CBC) analyzer. The review revealed that TP1, TP4, and TP5 performed non-waived testing on these analyzers for over one year without a documented annual performance evaluation. 2. On July 16, 2026, at approximately 2: 00 PM, an interview was conducted with Technical Consultant 1 (TC1). During the interview, TC1 confirmed that TP1, TP4, and TP5 had performed non-waived testing for over a year and that their annual competency evaluations had not been performed. 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 --