Scientific/Medical Testing: Diagnostic Laboratory Operations

Develop recommendations for strategic growth using existing diagnostic facilities and technology

Background

Diagnostic laboratory facilities have a lot of moving parts. Once tests are ordered by healthcare providers, a complex process is set in motion that includes scientific expertise, technical skill, software integration, and clear lines of communication. A laboratory director or manager oversees all processes and procedures. While making sure everything is running smoothly, the director also makes strategic recommendations about potential areas of growth for the company. Combining knowledge of the technical and human capabilities of the laboratory with expertise in scientific research, the director/manager can identify new targets that can be tested with existing resources, develop the necessary experiments to validate the new tests, and design protocol to integrate the new testing into the current laboratory systems.

The Process

  1. Competitor Analysis – Examine similar companies to determine what additional disease targets they are testing for that your lab does not currently offer.
  2. Disease Target Research – Review scientific literature to determine specific recommendations and clinical diagnostics standards around the new potential testing
  3. Evaluate the reimbursement fee schedule for the testing to determine whether revenue would be generated
  4. Validation Process – Design a series of experiments to demonstrate that current testing procedures fit within specific criteria for new targets
  5. Develop standard operating procedure, performance specifications, and protocol for the Laboratory Developed Test (LDT)
  6. If all criteria are met, develop requisition forms for providers
  7. Integrate with laboratory information management software (LIMS)
  8. Set up billing to communicate with insurance companies for reimbursements
  9. Go live with test

Your role:

For this exercise, you are an intern assisting the laboratory director research potential testing that could be integrated into the current diagnostic offerings.

The exercise:

Create a spreadsheet with the results of Steps 1-3 of the process outlined above. Your research aim is to determine several new disease targets for an existing diagnostic laboratory which offers clinical toxicology testing from urine and oral fluid specimens and pharmacogenetic testing from cheek swab specimens.

The facility where you are interning wants to utilize their molecular testing equipment and wants to provide molecular microbiology testing in any of the following three categories: upper respiratory pathogen, sexually transmitted infection, or gastrointestinal pathogen.  Your goal is to expand testing services by looking for specific targets in ONE of these three categories that can be tested through the current specimens received at the laboratory.

Task 1: Competitor Analysis

Step 1 of the process above. Make a list of targets in your chosen medical category being tested at diagnostic facilities (see a list in Resources) offering urine and/or oral fluid toxicology testing in one of the three molecular microbiology categories.

Task 2: Clinical Diagnostic Standards Research

Review information published by the Lab Test Online to determine specific recommendations for clinical diagnostics standards around the new potential testing targets you identified in Task 1. Other resources are Centers for Disease Control and clinical textbooks or medical society guidelines.

Task 3: Reimbursement Payout Research

Determine the reimbursement payouts set by the Centers for Medicaid and Medicare Services (CMS) for each of the targets you identified in Task 1. Use the current procedural terminology (CPT) codes to determine the payouts for each test. Determine the payouts through research on Quest’s website, descriptions in the CMS fee schedule (download latest file), and BioFire’s website.

The Deliverable

The results of each task should be added to a new column of the same spreadsheet.  The Task 1 deliverable will be a list of upper respiratory, sexually transmitted or gastrointestinal disease targets that can be listed in Column A. The information from the other tasks will be added to the same spreadsheet.

The Task 2 deliverable will be information regarding the diagnostic standards for each of the disease targets you identified in Task 1. You may wish to place each standard in a different column. This data would inform the testing experiments developed to determine whether the laboratory could successfully add the test to their offerings.

The Task 3 deliverable will be financial information related to each target and can be added to another column in the spreadsheet. This data will be used to determine whether enough revenue can be generated by the test given the amount of resources and time needed to complete the test.

Resources:

Skills used to perform this task:

  • Research
  • Learning new things
  • Organizing Information

Skills used in the field:

  • Project Management
  • Collaboration
  • Organization
  • Communication Skills
  • Problem Solving

Additional tasks:

A professional in the field of Diagnostic Laboratory Operations may also perform these tasks:

  • Coming soon!

You are viewing a job simulation. To get started, set up SMART Goals to perform this simulation in a reasonable timeline. If you have completed the task, fill out the Self-Reflection Sheet.

Simulation author: Sarah Peterson, PhD, in collaboration with Emory and Georgia Tech’s NIH BEST
This simulation vetted by professionals in the Greater Atlanta Area