Checklist of Best Practice for Risk Management in Statistical QC

Click here to download your Checklist Today!

  1. Print or Share this pdf checklist in your lab, among your colleagues. The form can be filled in and saved.
  2. Audit if your medical laboratory is following best practice for Risk Management in Statistical QC.
  3. Optionally – Send your completed pdf checklist file back to us. We will include your data in an anonymous study to be presented first in an upcoming webinar.

You will receive a link to the fill-in-able PDF to download, plus an option to submit the same information in an online survey and an invitation to the next webinar.

These recommendations were written by global experts through collaborative processes coordinated by ISO, CLSI and CLIA

These are the best practices recommended in

  1. ISO/IEC Guide 51 Safety aspects — Guidelines for their inclusion in standards
  2. USA CLIA 42 CFR 493.1445 – Standard; Laboratory Director responsibilities
  3. ISO 15189:2012 Medical laboratories – Requirements for quality and competence
  4. CLSI EP 23-A. Laboratory Quality Control based on Risk Management

Unlike the quality control charts and rules that clinical laboratories have used for decades to detect errors in analytical processes, Risk Management also evaluates the acceptability of risk by comparing existing analytical process quality and Quality Control process effectiveness to acceptable risk criteria that satisfy “The PIPS.” As in all other areas, now the required level of quality for lab results is set (or at least approved by) the people whose lives are impacted by those results.

Risk management concepts present an opportunity to re-think, simplify, and significantly improve medical laboratory quality. Forget statistics for now – look at risk management from a new perspective.

This checklist highlights the key recommendations from global sources.


Hint from Belle: Beware – these are quotations from scientific references. Read the jargon carefully!

  • Medical laboratory directors who want to “ensure that the test methodologies selected have the capability of providing the quality of results required for patient care” and “ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.” Also, to protect the reputation of their laboratory.
  • Laboratory managers who want to ensure that their QC processes are indeed effective to maintain the quality standards set by the laboratory director.
  • Patients who lives are impacted by medical issues such as tumors and kidney disease which are diagnosed too late, plus the cost and risk of follow-up tests from a false positive result.
  • Institutional CFOs, risk managers, CEOs who pay the cost of unnecessary laboratory tests and avoidable clinical costs.
  • Physicians, who may be misled by incorrect laboratory results.
  • Society, who pays the price of healthcare and patient well being.

The Checklist will help you determine:

  1. How important are the issues of laboratory risk, patient harm, error rates and cost?
  2. If your laboratory has clearly defined the size and probability of error that puts your patients at UNACCEPTABLE risk?
  3. Do existing Quality Control processes and reports relate to patient risk and harm?
  4. Do your existing laboratory statistical quality control practices meet the best-practice recommendations to manage patient risk?

You can:

  • Use the PDF as an internal audit. Circulate it to your supervisors, department heads, quality managers, front line staff.
  • Upload it to be included in global peer comparisons. You will receive upload instructions when you download the PDF.
  • Not bother with the PDF – just take the online survey.
  • Consider the possibility that laboratories can slash financial risk exposure by setting medical goals and evidence-based acceptable risk criteria – and using only validated software to manage risk to meet those standards.