How it Works

  Pro-QCP is divided into risk categories...

 Mouse over the Fishbone diagram to see an example of the risks which are covered  

 

  Pro-QCP is pre-populated with test system data and suggests a series of risks that are applicable to your test system as used in a variety of environments. You are prompted to identify each risk that is applicable to your particular test process and make an initial determination as to its acceptability...

 

  For each risk, Pro-QCP helps determine the severity of harm and the probability of occurrence. Pro-QCP ‘recommends’ a probability of occurrence based upon your historical occurrence rates for that particular risk, in context of the test volume at that particular location...

 

  You may edit, omit, or add risks as appropriate to your situation...

 

  For each unacceptable risk, you will be prompted to review suggested risk mitigation efforts (QCP’s) that help mitigate that risk, as appropriate for your particular test process. Pro-QCP will also prompt you to determine the appropriate frequency and acceptance criteria for each QCP. You may also categorize your ability to detect that risk...

 

  You may also ‘flag’ particular QCP’s that you are not currently employing but that could further mitigate risk and help improve patient outcomes. Pro-QCP captures these in a Suggestion Report for future consideration...

 

  Similar to risks, you may edit, omit, or add QCP’s as appropriate to your particular testing situation. Also, Pro-QCP provides specific source document citations (e.g., Operator’s Manual, Instructions for Use, Troubleshooting Guide, etc.) for most risks, and allows you to reference QCP’s as to where those risk mitigation efforts are addressed in your own facility’s policies and procedures documentation...

 

  Pro-QCP’s Quality Assessment section allows you to inventory the ways you monitor the effectiveness of your IQCP and risk mitigation efforts over time...

 

  Pro-QCP will systematically guide you through a comprehensive risk assessment, will document that process to satisfy your federal regulatory requirement, will organize that information to streamline future validations, and will identify initiatives that can improve patient outcomes.  At the same time, Pro-QCP will save you hours and hours of effort!

 

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