Our Services

Zilgene is a lab building consultant and clinical lab startup consultant helping laboratories launch, restructure, and stay inspection-ready — from CLIA compliance consulting to full laboratory build-outs.

Compliance

  • CLIA license applications and changes

  • CAP and COLA Accreditation applications and changes

  • State-specific (CA, NY, FL, etc) license applications

  • Interim lab director, clinical consultant, and technical consultant services

  • Evaluation of laboratory director, clinical / technical consultant, and Laboratory personnel qualifications

  • Mock inspections, Inspection readiness and GAP analysis

  • Responses to audit and inspection deficiencies and establishment of corrective action plans.

  • Standard laboratory SOPs

  • QC records evaluation

  • IQCP

  • QA plan

  • Assistance in Establishing Requisition forms

  • Patient reports that meet CMS requirements

  • General guidance for CPT coding

  • Enrollment in appropriate proficiency testing and alternative assessment plans for analytes with no PT available.

  • LIS and EMR integration support

Business Planning

  • Performance Management

  • Forecasts

  • Strategic Marketing Support

  • Facilitator

  • HR and Management Reporting

Laboratory building and testing implementation

  • Molecular Testing (COVID-19 PCR, Respiratory Panel, UTI, STI…)

  • Hematology

  • Chemistry

  • Toxicology

  • Flow Cytometry

  • Cytogenetics, FISH

  • Anatomic pathology

  • IHC, ISH

  • Microbiology

  • Instrument selection and test validation/verification support

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What people are saying

 

“Prior to Zilgene joining our team, we had just gone through a CLIA Inspection with many challenges. Plans were made to switch to COLA as well as integrate LIS with our current EMR. Under Imad’s guidance, he instilled confidence in me to work to achieve this goal. When I lost focus, they encouraged me. What I thought was impossible, became a reality. They are very resourceful and encouraging when the times get rough.”

— Anna Frasher,

QA manager at Riceland Medical Center

“Zilgene consulting has been instrumental in the setting up of new test modalities, including validations and establishment of compliance practices,  at our lab.  The entire team has exceptional knowledge of instrumentation, regulations, record-keeping, laboratory information systems, and laboratory start-up processes.   For laboratory consulting, I give my highest recommendation to Zilgene”

— Denise Francois, MD

Medical Director XCELL Laboratories