Summary:
Summary Statement of Deficiencies D0000 An Initial (Validation) Clinical Laboratory Improvement Amendments (CLIA) survey was completed on January 25, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of personnel competency assessment records and an interview with the laboratory director, the Technical Supervisor failed to include the six required competency assessment criteria by CLIA when evaluating competency on testing personnel for 2016 and 2017. The findings include: 1. Review of testing personnel (TP #1 and #2) competency assessment records for 2016 and 2017 revealed the assessment did not include the six competency assessment criteria required by CLIA. 2. An interview with the laboratory director in the review room on January 25, 2018 at approximately 01:00 PM confirmed annual competency assessments done did not contain the six required assessment criteria required by CLIA. 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 --