Before purchasing instrumentation to add more in-house tests for the Providers, fundamental questions need to be asked:
- Does the new testing result in the need for more personnel?
- Do the new tests require a change in the laboratory's CLIA category (e.g. from waived to moderate or moderate to high complexity)?
- Does adding these tests fit with the mission, purpose, and goals established for the laboratory?
- Is there an actual need for the tests?
- Will the Providers and/or patients have greater convenience?
- If there is a need, can the test be sent out with the same patient outcomes?
- Is adding a testing instrument financially viable?
If more personnel are needed, will the added revenue cover the expenditure? Changing from Waived to Moderate or Moderate to High Complexity CLIA category creates additional expense and often a higher level of personnel. Can this be justified? Quicker turnaround times can be important to better patient outcomes by helping the Provider to make a faster diagnosis and treatment plan. The study designer needs to work with the Provider to determine if this will occur.
All of these factors need to be taken into consideration before moving forward.