(520) 251-6700
Our Services
Bio-Lab Consulting, provides a complete solution for any medical laboratory; from inital LICENSURE, developing STANDARD OPERATING PROCEDURES(SOP's), preparation for LAB INSPECTIONS, Eatablishing QUALITY ASSURANCE standards and continuing LAB OPERATION. Our goal is to develop systems and procedures to ensure a sucessful Laboratory.
Laboratory Licensure
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Initial application to CLIA.
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Establish Dept. of Health & Human Services requirements.
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Assist Lab Director in completing the requirements for Licensure, based upon LAB Complexity.
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Submission of necessary documentation to COLA.
Laboratory Inspection
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Review and update all SOP's as required.
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Review and verify all QC corrective actions are complete and updated.
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Ensure Lab staff are trained and competencies are completed.
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Ensure all equipment maintenance logs are complete and current.
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In-person, onsite during Lab Inspection.
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Document any corrective action required, post inspection.
Quality Control
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Provide written SOP's for all LAB Equipment, Testing and Procedures.
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Monthly Controls performance and accuracy review.
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IQCP development for non-waived tests.
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Review and documentation, of all Proficiency Testing, establishing corrective action as required.
Laboratory Operation
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Six month calibration performance verification, for all tests.
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Updating reportable ranges, based upon calibration verification.
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Six month and annual training and testing for Lab staff competencies are current and complete.
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Annual Safety training for Lab staff.
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Annual calibration of all thermometers, timers, pipettes and centrifuges.
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Manufacturers technical bulletins and preventative maintenance procedures are performed and documented.