Scientific/Medical Testing: Diagnostic Laboratory Operations

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. Directors also make sure that diagnostic testing that is brought in is compliant with the federal laws and regulations (e.g., tests are FDA cleared and FDA approved). 

Diagnostic labs are part of clinical systems like hospitals, and also public health institutions like the CDC. Specifically at public health institutions, diagnostic lab directors combine knowledge of lab capabilities with expertise in scientific research to identify new targets and existing or emerging diseases. Using their technical and human capabilities, labs use existing resources to develop the necessary experiments to validate the new tests, and design protocols to integrate the new testing into the current laboratory systems.

The Process

1. Landscape analysis – examine similar companies to determine what additional disease targets they are testing that your lab does not currently offer.
2. Research disease targets – 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. This step varies largely, and depends on lab size and funding.
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. Communicate with downstream providers and clients about new diagnostic test availability.
10. Go live with the test.

Your role:

For this exercise, you are an intern in a public-health focused diagnostic lab. You are assisting the laboratory director to 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 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: Landscape Analysis

Step 1 of the process above. Select one of the three molecular microbiology categories – upper respiratory pathogen, sexually transmitted infection, or gastrointestinal pathogen. Make a list of targets in your chosen category being tested at other diagnostic facilities (see Resources section for a list of places to research targets) offering urine and/or oral fluid toxicology testing in. Consider the appropriate specimen type for validation (e.g., oral or nasal swab for respiratory diseases).

Task 2: Clinical Diagnostic Standards – Research Your Target

Step 2 of the process. Review information published by the Lab Test Online to determine specific recommendations for standard diagnostic(s) around the new potential testing targets you identified in Task 1. 

This information would inform the testing experiments developed to determine whether the laboratory could successfully add the test to their offerings.

Task 3 (advanced): Reimbursement Payout Research

Getting familiar with CPT codes is important for this intern role. Find the current procedural terminology (CPT) codes associated with the tests you identified in Task 2. You’d typically use a giant book of CPT codes. For this online task, find CPT via Centers for Medicaid and Medicare Services (CMS) fee schedule. (Download the most current file. You’ll have to accept the terms and download the zip file. CPT codes are found in the excel file.)

Or research CPT codes on Quest’s website and BioFire’s website. 

This information would 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. 

Note: Reimbursement is complicated and highly variable depending on the diagnostic lab. Some labs reimburse on disease and not on the test. Larger labs may also leverage better cost for tests based on volume of orders. Diagnostic lab directors often make decisions first on what’s best for the patient before considering cost.

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 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. 

For example, the clinical method that is most effective for diagnosing Chlamydia is molecular testing (standard methods used to diagnose other sexually transmitted diseases are cervical cytology and culture). Other resources to check – Centers for Disease Control and clinical textbooks or medical society guidelines.

The Task 3 deliverable will be CPT codes related to each target and can be added to another column in the spreadsheet. 

In the current example, one code is 87491.

Resources:

• To find targets, refer to:
  • Reference labs such as the Mayo Clinic
  • FDA 510k database for published clinical trial data.
  • Publications on the disease. Search Pubmed
  • Google the “test name” and “FDA”
  • Examine package inserts
• Large diagnostic facilities that could also be used to determine a list of possible targets:
  • Quest Diagnostics
  • Diagnostic Laboratory Services
  • LabCorp
  • Medical Diagnostic Laboratories
  • Manufacturers of testing equipment:
  • BioFire
  • Siemens Molecular Diagnostics
• Clinical Diagnostic Standards Research can be done through Centers for Disease Control and Lab Test Online
• Reimbursement are set by the Centers for Medicaid and Medicare Services (CMS). 

Skills used to perform this task:

• Research
• Critical thinking
• Molecular testing (specific knowledge)
• Curiosity and learning new things
• Organizing information

Skills used in the field:

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

Additional tasks:

A professional in the field of Diagnostic Laboratory Operations may also perform these tasks (Insights into Lab Director Responsibilities from COLA, a clinical laboratory accreditation, education and consultation organization):

• Assess facility for safety and set safety plans
• Ensure testing systems and procedures produce high quality, accurate, and pertinent results
• Ensure compliance with local, state, and federal regulations
• Manage Personnel 
• Communicate effectively with healthcare providers (clients and providers) about laboratory’s test results