Change vs. Failure: Are you wasting time and delaying patient results when QC shifts for the BETTER?
Do you still assume that all QC flags indicate clinical failure? In fact, change can be for the better or the worse; acceptable or unacceptable.
I had the privilege of working with Dr. James Westgard in the early/mid 1990s and he always emphasized that “The only message QC can send is ‘Excuse me, your method has changed.’ You need to compare to the True Value and TEa to decide what that change means.
I am creating a Problem-Solving Worksheet for the upcoming Masterclass on Risk Management (https://awesome-numbers.com/risk-management-masterclass/) and struggling with the question of “What comes first?” Should labs determine if a change identified by QC still leaves the analytical process within acceptable limits, before investing time investigating the cause of the change and repeating patients?
Even if the method shifted closer to the True value, making QC statistics better – the clinician will see a change in patients being monitored.
What do you think? Please share and comment.
Apparently, ISO 15189 requires a risk assessment when a QC failure occurs. “Examinations are halted, and reports withheld when there is a risk of harm to patients.”
7.5 Nonconforming work
The laboratory shall have a process for when any aspect of its laboratory activities or examination results do not conform to its own procedures, quality specifications, or the user requirements (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The process shall ensure that:
a) the responsibilities and authorities for the management of nonconforming work are specified;
b) immediate and long-term actions are specified and based upon the risk analysis process established by the laboratory;
c) examinations are halted, and reports withheld when there is a risk of harm to patients;
d) an evaluation is made of the clinical significance of the nonconforming work, including an impact analysis on examination results which were or could have been released prior to identification of the nonconformance;
e) a decision is made on the acceptability of the nonconforming work;
f) when necessary, examination results are revised, and the user is notified;
g) the responsibility for authorizing the resumption of work is specified.
The laboratory shall implement corrective action commensurate with the risk of recurrence of the nonconforming work (see 8.7).
The laboratory shall retain records of nonconforming work and actions as specified in 7.5 a) to g).
The Masterclass will include an AI simulator that allows users to introduce shifts to fail acceptable risk, or by a defined portion of the mean or SD. This will assess the change as acceptable or unacceptable compared to acceptable risk levels. If the risk is unacceptable, there is a Problem-Solving Worksheet to investigate the probable cause and record planned corrective action.