The laboratory director is responsible for the overall operation and administration of the laboratory, including employing personnel who are competent to perform test procedures and record and report test results promptly, accurately, and proficiently, and for assuring compliance with CLIA'88.  Our lab director is available to provide on-site, telephone, or electronic consultation as needed. Our lab director also assumes the position of technical consultant and clinical consultant. (* = cannot be delegated)


n      *Provide a safe and appropriate environment for personnel


n      *Test methodologies provide quality results and verification procedures are adequate to determine accuracy, precision, and other performance characteristics


n      *Personnel are qualified to perform their responsibilities as defined by CLIA '88. Responsibilities are specified for each employee and consultant in writing that identify which procedures the individual is authorized to perform, whether supervision is required for testing, and if consultant or director review is required prior to result reporting


n      Lab personnel perform test methods as specified to obtain accurate and reliable results. Procedure manuals are available to testing personnel that have been signed and dated by the director at initial use and at any time there is a change in the procedure


n      All aspects of proficiency testing are properly followed and PT results are reviewed


n      Quality assurance and quality control programs are established and maintained


n      Acceptance levels for analytical performance for each test are established and maintained


n      Test results are reported only when all performance specifications for a test are within acceptable limits


n      Remedial actions are taken and documented when required by CLIA '88


n      Result reports include pertinent information required for interpretation


n      Consultation is available and communicated to the lab's clients on matters related to the quality of the test results reported and their interpretation


n      Personnel  have been checked to assure their competence prior to reporting results. Policies and procedures exist to monitor testing personnel and identify needs for remedial training and/or continuing education




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