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Clinical Priorities

As the number of primary care providers diminishes and the need for primary care increases, the fundamental unmet need is to increase the ability of providers to care for more patients without decreasing the quality of care given and without unduly burdening the providers, patients or their families.

In general, two POC technology-enabled pathways to increase primary care capacity are:

  1. To introduce point-of-care technologies that eliminate unnecessary steps and re-work to increase the efficiency of operations.
  2. To offload selected testing and self-monitoring capabilities to the home or community settings for patient self-management.

To accelerate clinical adoption of POCT in the primary care environment and minimize potential barriers to acceptance, point-of-care technologies should address the following requirements:

  • Result Availability: Results must be available during the office visit (typically 10-20 minute result availability) so that decisions can be made in a timely fashion based on the test results.
  • Ease-of-Use: Ease-of-use is essential to successful implementation of POCT test devices. In the case of instrumented devices the user interface with the device should be designed to ensure regulatory compliance under the clinical laboratory improvement amendment (CLIA-88) with minimal requirements for intervention by the operator. Results readout must not be subjective but easy to read using color change readout, digital or graphic formats.
  • Reducing Operator Errors: The device should have built in software safeguards to ensure proper operation and reduce common errors such as lock-out of untrained operators, lock-out for failed quality control (or failure to perform quality control) and lock-out of expired reagents.
  • Sample Types: Samples that do not require a trained phlebotomist should be used such as capillary finger-stick whole blood or saliva.
  • Storage of Consumables: All consumables including reagents, calibrators and quality control materials should be able to be stored at room temperature. The shelf life should be minimally 6 months to 1 year.
  • Device Footprint: POCT devices should be designed to have as small a footprint as possible. Small bench top or handheld devices are optimal.
  • Information Connectivity: All instrumented POCT devices should be capable of being interfaced to the electronic medical record system. The ability to transmit data using a bidirectional wireless interface is most optimal.
  • Analytic Performance: As a general rule, the point of care devices should perform equally to central laboratory instruments with regard to analytical accuracy, reportable range and imprecision. Analytical time should be kept to a minimum (less than 5 minutes for common chemistry analytes and less than 15 minutes for immunoassays).
  • Cost: Solutions that significantly reduce the cost of testing relative to the existing standard of care are encouraged.
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