Centralized vs. decentralized testing models and the importance of both for COVID-19 testing

June 18, 2020

Testing helps healthcare providers determine the overall status of an individual’s health and the diagnosis of disease. In the healthcare environment, testing can be done in two primary environments:

 

  • Centralized testing: Samples are obtained at a collection site and then delivered to a laboratory where multiple patient samples and types of tests are run by trained laboratorians. This type of testing is typically done in a hospital or offsite reference lab, oftentimes on complex platforms that offer high- throughput processing from hundreds to thousands of patient samples during an eight hour shift.
  • Decentralized or “Point of Care” testing: Single sample or low volume testing that occurs near the patient at collection of the sample. Tests are oftentimes conducted by a wider variety of healthcare workers - not limited to lab professionals. These types of tests can be performed at the patient bedside or even at a clinician’s office — offering rapid turnaround times. Other places of use include but are not limited to Urgent Care settings, Emergency Departments, and community pharmacies.

 

Both types of testing are important in today’s healthcare environment as they each have unique benefits.

 

Centralized Testing

 

Automated high throughput laboratory instruments help healthcare institutions efficiently process a high number of samples while maintaining a high level of quality and integrity of the result. Performing testing in a centralized laboratory also enables highly trained staff to run tests in a controlled environment, perform distribution analysis and study repeatability. They can process a significant amount of samples with great efficiency and with a high level of automation, which requires less manual support.

These factors make centralized testing a critical resource when a high volume of tests need to be processed and an “immediate” result does not have an impact on the clinician’s treatment decisions for the patient.

 

Decentralized or “Point of Care” Testing

 

There are times when a result is extremely valuable closer to the patient. Tests conducted near the patient or at the “point of care” (POC) provide healthcare provides with answers that can quickly help determine a course of action or treatment for a patient. This has obvious benefits in almost any setting — from the emergency room, in a community pharmacy, or even to a patient receiving at home care. Numerous peer- reviewed publications have shown that testing for respiratory infections at the POC can:

 

  • reduce a patient’s length of stay
  • enable appropriate timely treatment
  • aid with antimicrobial stewardship efforts
  • reduce unnecessary downstream testing
  • eliminate the need for confirmation testing
  • enable appropriate patient isolation

 

With the implementation of the Clinical Improvement Amendments of 1988 (CLIA), performance standards for laboratory testing became regulated by the Centers for Medicare and Medicaid Services. The classification of laboratory tests is determined by complexity (waived, moderate, and high). Those tests that are considered CLIA-waived must use direct, unprocessed specimens and be easy to perform with negligible chance of error. CLIA-waived tests can be performed by individuals without formal laboratory training due to data that supports their use in decentralized settings. Many tests performed at the point of care are considered CLIA-waived.

Both Centralized and POC testing have an important place in healthcare, and in the case of the current COVID-19 pandemic we need to leverage both approaches to meet the demand for widespread testing.