Quality Control and Quality Management
Precision and accuracy for quality control used to be a lot more simple said Elissa Passiment, executive director of ASCLS. She presented Friday morning on quality control management.
CDC and CLSI have evaluated quality control systems and are examining what should realistically be required. For example; How much QC is really necessary? On what basis should labs make decisions about their QC programs? What test components should be monitored by QC?
Additionally, do you need to have different quality control based on the competency of your staff? For example, Passiment explained, someone works in microbiology but may be pulled into another specialty once a week. Should this employee run controls in an area where she is not fully competent?
"It should not surprise you that we are not global with the ISO standards," Passiment noted, laughing that Americans have been resistent to the metric system, saying, "We are still measuring in miles, bushels and pecks!"
She stressed manufacturers should inform users of residual risk, namely under what conditions will the system fail? How likely is it to fail? What happens to the patient if the system fails? How competent does the user need to be to run the system?
The session provided extensive information on EP-22. EP-22 was created as a means to use risk management to allow manufacturers to recommend the frequency of external quality control in clinical laboratories.