Summary:
Summary Statement of Deficiencies D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory director failed to assure all testing personnel maintained their competency to perform Complete Blood Count (CBC) testing for 1 (Testing Personnel #1) of 4 testing personnel listed on the CMS-209 form. Findings include: 1. A record review of testing personnel competency records exposed a lack of competency performing CBC testing for 1 (2018) of 2 years for Testing Personnel #1. 2. An interview on 7/17/19 at 11:03 am with the LD confirmed competency records for 2018 were not available for Testing Personnel #1. 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 --