Ongoing Consulting Services For Laboratory
- LC-MS/MS patient data processing conducted by CLIA-qualified scientist during the term of the contract. This service includes data review, interpretation, confirmation and certification of results of drug panels by our board certified Toxicologist. Certified results will be provided to the diagnostic laboratory as a report generated by a state of the art LIS. The completed report is customized for your laboratory,
- Guaranteed 24-48 hour turnaround time of data processing (excluding weekends and holidays).
- Daily analysis and evaluation of QC’s, in addition to monthly summaries.
- Provide training and continuous support for all technical staff, including instant communication via email and personal cellular telephone.
- Monitor instrument performance and troubleshoot any issues that may arise, including technical assistance in person or by phone and WebEx
- Split specimen/correlation analyses
- Oversight during the inspection process with various regulatory agencies.
Lexar Consulting will provide the following clinical and administrative services to manage and facilitate the operations of the Diagnostic Laboratory:
- Policies, charts, and operational logs to comply with initial setup requirements. Establish maintain and monitor quality controls, and calibrations. In conjunction with the Laboratory Director, develop and maintain standard operating procedures for all laboratory LC-MS/MS related tasks.
- Monitor quality control procedures, conduct monthly reviews of generated data, and evaluate the accuracy of those data.
- Assist in the completion of proficiency or split lab surveys as required by the lab director in compliance with CLIA and other regulatory agencies. Ensure that applicable proficiency testing procedures are followed, reviewed, and modified as warranted.
- Lexar Consulting will visit the laboratory site as needed to ensure compliance with CLIA regulations and for purposes of quality assurance. Lexar Consulting will also be available to the Diagnostic Laboratory to address any associated issues. Furthermore, Lexar Consulting will keep Diagnostic Laboratory management fully informed of all critical matters relating to lab operation and will be present during scheduled accreditation inspections.
- Perform pre-inspection checklists and self-assessments, assist in on-site surveys with the inspection team, follow-up with any post survey meetings/discussions, and take corrective actions regarding any deficiencies noted by the inspecting or accreditation agency (related to the LC-MS/MS LDT).
- Lexar Consulting will assist in maintaining and keeping current all written policies and procedures for the Diagnostic Lab related to the LC-MS/MS LDT, including policies and procedures regarding quality controls, test procedure manuals, incident/complaint reporting, and records retention.
- Lexar Consulting shall be responsible for the training of acceptable staff, who are competent to perform testing to Diagnostic Laboratory standards. Management acknowledges that the staff shall be employed by the Diagnostic Laboratory, and work under the direction of the Diagnostic Laboratory and Lexar Consulting while in performance of duties.
- Conduct semi-annual (6 months) performance evaluations and competency documentation for laboratory technicians.
- Lexar Consulting will be available Monday through Friday for troubleshooting, consultation, and corrective actions for the LC-MS/MS equipment, and will make best efforts for emergency events after hours and on weekends. Personal email and cellular phone numbers will be made available in order to provide technical staff with immediate access to assistance.
- If circumstances arise (e.g. technician vacation, sick leave, Instrument maintenance, etc.) which prevent on-site analysis for a limited period of time, Lexar Consulting will make best effort to provide on-site substitute for technical staff for limited periods during such events.