Key elements | Description |
---|---|
Training of users | protocol available as part of the quality system, |
users must be trained, certified | |
periodical refresher courses | |
Pre-analytical phase | check control measures upon delivery of POC tests: |
  -storage condition | |
  -packaging undamaged | |
  -expiry dates | |
check control measures before using POC tests: | |
  -instruct the patient | |
  -read instructions for use or own written protocol | |
  -check storage condition | |
  -packaging undamaged | |
  -expiry dates | |
  -regular maintenance and calibration of POC test meters | |
Analytical phase | perform patient identification |
take the appropriate hygienic measures (e.g. washing hands ) | |
correct sample handling | |
Post-analytical phase | record test results |
take control measures and action in case device failure, such as: | |
  -refer a patient or sent the sample to a laboratory for testing | |
  -contact the manufacturer of the POC test | |
  -check the expiry date of the POC test | |
  -repeat the test with an other POC test | |
  -repeat the test with a new sample | |
take control measures and a actions in case the test results conflict with symptoms, such as: | |
  -refer a patient or sent the sample to a laboratory for testing | |
  -repeat the test with an other POC test | |
  -repeat the test with a new sample | |
  -give life style advice | |
prescribe medication |