Laboratory Developed Tests And Validation
- Lab equipment package customized to your needs, including equipment, drug standards, columns, solvents and chemicals – Everything required to equip and operate the lab through the method development and validation
- Laboratory Developed Test (LDT) Method Development-Provide complete methods for customized analysis of 50-60 drugs and assist Diagnostic Lab Technician to validate the method in accordance with CLIA regulations. Designed for pain practices and medically assisted treatment/addiction clinics, but may be tailored to your needs.
- Provide sample preparation and LC-MS/MS standard operating procedure (SOP) manuals, CLIA/CAP/COLA policies, staff competencies, and all documentation necessary to maintain compliance with the various regulatory agencies.
- LC-MS/MS instrumentation may be customized to perform high complexity screens to eliminate the additional costs and maintenance associated with an immunoanalyzer.
- Barbiturates (2-5) can be included as a separate panel on a Sciex 3200MD or API 4000 at no additional charge upon request. Barbiturates may be combined into a single panel with a Sciex 4500, 5500 or 6500 using positive-negative switching method.
- Ethyl glucuronide (ETG) and ethyl sulfate (ETS) may be added as a separate panel for an additional charge.
- Validation consisting of 16 studies for custom LC-MS/MS LDT
- Laboratory staffing assistance, including CLIA-qualified Lab Directors, Technical Supervisors, and Laboratory Technicians
- Custom laboratory manuals and documentation (standard operating procedures, CLIA/CAP/COLA policies, staff competencies, etc.)
Requirements Of Diagnostic Laboratory:
- Direct the clinical operations of the on-site Diagnostic Laboratory and personnel. Provide a qualified physician to act as the Medical Director.
- Diagnostic Laboratory shall be licensed by CLIA to perform testing in compliance with current CLIA regulations. Lexar Consulting will assist with obtaining or updating the CLIA certificate.
- Lexar Consulting and Diagnostic Laboratory shall require that all lab support personnel record, maintain, and complete, accurate records or clinical notes reflecting the provision of services furnished in the Diagnostic Laboratory. Diagnostic Laboratory shall permit access by Lexar Consulting to patient laboratory records strictly relating to the provision of services by Lexar Consulting, subject to federal and state confidentiality laws.
- Provide installed, functional Sciex 4500 (MD) (or other current Sciex MS/MS) and LC Shimadzu 20AD or 20AD XR. LC’s must consist of binary pumps with column oven, micro mixer, autosampler, controller and degasser.
- Diagnostic Laboratory shall be responsible for furnishing adequate space for the diagnostic lab, appropriate power and environmental control, an internet access point, and a sink with running hot and cold water. In addition, Diagnostic Laboratory shall furnish appropriate LC-MS/MS and supporting equipment as agreed upon by Lexar Consulting and Diagnostic Laboratory.
- Laboratory must be fully equipped for performing drug panel confirmation and/or screening analysis. All consumables, including drug standards, columns, solvents, enzymes, acids etc., must be on-site before validation can begin (complete list can be provided by Lexar).
- Laboratory must provide a lab technician with a 4 year science or Med Tech degree qualified to be high complexity lab General Supervisor. Experience with laboratory procedures recommended, but other factors will also be considered. Lexar will assist with recruiting, interviewing, and recommending a qualified Lab Technician.
- Laboratory Director shall be accessible to consult with Lexar Consulting and/or Lab Manager in reviewing any potential CLIA discrepancies or other laboratory issues related to the Diagnostic Lab under this agreement.