Summary:
Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) 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 lack of training and competency documentation for the performance of Post vasectomy semen testing, review of the Accuracy Verification policy and interview with the Technical Consultant confirmed the Laboratory Director failed to ensure all testing personnel are trained and competent prior to performing patient testing for Post vasectomy samples in 2017 and 2018. The Findings include: 1. Lack of records for training and competencies for 2 out of 4 testing personnel's for performance of Post Vasectomy Semen verification testing for 2017 and 2018. 2. Review of the Accuracy Verification policy determined testing personnel are listed on the policy to perform Post Vasectomy Semen verification testing for 2017 and 2018. 3. Interview with the Technical Consultant on October 23, 2018 at 12:00 pm confirmed that the Laboratory Director failed to have training and competencies for 2 out of 4 testing personnel for Post Vasectomy Semen verification in 2017 and 2018. 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 --