The process of crafting an IQCP is linear, although the documentation of the IQCP does not have a prescribed format or requirement. The eight steps listed below incorporate the three parts that are required by CLIA for an IQCP, if your laboratory will be using it as a QC option for any nonwaived testing that has internal (electronic/built-in/procedural) controls.
- Define the process to be assessed.
- Study (through research, interview, and observation) and document the process.
- Identify the location and origin of risk in the process.
- Determine the probability and severity of harm to patients for each identified risk.
- Create a Quality Control Plan.
- Educate all personnel involved in the process.
- Put IQCP into action.
- Monitor and document IQCP effectiveness.
You may want to create your first IQCP for a process where the majority of the process is under the control of the laboratory and there is little variability. This will allow the team creating the IQCP an opportunity to learn best practices before guiding a multi-disciplinary team through more complex processes.