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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

  • Initial application to CLIA. 

  • Establish Dept. of Health & Human Services requirements.

  • Assist Lab Director in completing the requirements for Licensure, based upon LAB Complexity.

  • Submission of necessary documentation to COLA.

Laboratory Inspection

  • Review and update all SOP's as required.

  • Review and verify all QC corrective actions are complete and updated.

  • Ensure Lab staff are trained and competencies are completed.

  • Ensure all equipment maintenance logs are complete and current.

  • In-person, onsite during Lab Inspection.

  • Document any corrective action required, post inspection.

Quality Control

  • Provide written SOP's for all LAB Equipment, Testing and Procedures.

  • Monthly Controls performance and accuracy review.

  • Critical Results accuracy and reporting, matching EMR log.

  • Review and documentation, of all Profiency Testing, establishing corrective action as required.

Laboratory Operation

  • Six month calibration performance verification, for all tests.

  • Updating reportable ranges, based upon calibration verification.

  • Six month and annual training and testing for Lab staff competencies current and complete.

  • Annual Safety training for Lab staff.

  • Annual calibration of all thermometers, timers, pipettes and centrifuges.

  • Manufacturers technical bulletins and preventative maintenance procedures are performed and documented.

What Our Clients Say

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Dr.  Stephen Buksh - NETIMA

"I highly recommend consulting with Barbra James. Our primary practice has worked with Barbra for the past 8 years and she has been essential to the success of our lab. She upholds a standard of excellence regarding compliance, auditing, lab testing and problem solving around complicated regulations ."
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