You want to inventory all of the known risks in your test process, and everything you are doing to address and mitigate those potential sources of error. So you have two options: You can inventory all of your risks first and then come back to consider the QCP’s, OR you can consider each risk and its associated QCP’s at the same time.

It is important (and a US federal requirement) to include input from personnel that are performing the actual specimen collection and testing in your risk assessment.

Wherever possible, you should base your risk assessments on historical data (a federal requirement). If you don’t have actual or reliable historical data for each metric, proceed using your best estimates.

All of the suggested risks and QCP’s that are pre-populated into the program are merely suggestions.It is up to you to accept or reject each suggestion as applicable to your lab, and add any additional risks that you have previously identified and QCP’s that you have already deployed.

Next to each risk and QCP, there is a pop-up text block that allows you to make any notations, including citations to applicable regulatory/accreditation requirements and/or to provide links or references to your lab’s internal QA documents.

Pro-QCP will allow you to factor your institution’s overall tolerance for risk into your assessment. A Risk Acceptability Matrix is presented the first time you sign onto the program. You can accept the default settings recommended by ISO 14971 and CLSI EP-23, or you can adjust the matrix to suit your institution’s own risk tolerance preference.

Pro-QCP works well with the most popular web browsers, particularly Chrome, Firefox and Safari. If you are having difficulties, you might try updating your browser or accessing the program from a different browser. If problems persist, please contact the Pro-QCP User Support Team.

CarePoint Solutions will be updating Pro-QCP with many new features in the future: KPI monitoring, inter-lab comparisons, industry benchmarks, educational tracks, integrated delivery network summary reports, etc. New features are added to current annual subscriptions at no extra charge.

Over time, CarePoint will add new risks and risk mitigation actions that have been identified and proven by other users of Pro-QCP. When you come back to your assessment, you may see new suggestions and opportunities to further improve the reliability of your test results.