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Sunday, March 27, 2011

Critical Incidents in the Research Laboratory

My university has a course for undergraduates which leads to a degree called the Bachelor in Medical Laboratory Sciences (BMLSc).  It was originally designed as a program for medical laboratory technologists to re-enter the academic stream, however in the last 10 years I suspect there has not been a single RT that has enrolled.  Most of the students are from from a science stream with no background in clinical laboratories.

It is a typical 4 year bachelors degree program.  Some of the graduates continue through a MSc or PhD, or apply to Medical School.  Many do a reverse entry and go on to take RT training to find work in the clinical laboratory.  Some  find work as research technologists either in the university or private sector.
 
I provide them with a lectures in Quality and Laboratory Safety. The laboratory safety lecture is straight forward, but I regularly have a dilemma about how to cover in the Quality presentation.  It is a subject about which they have little to no knowledge, or experience, or a frame of reference.   It is relatively easy to give a context for those interested in ending up in a clinical laboratory, but there are no quality management standards or even best practice guidelines actively in play in the research laboratory setting.  Today the only quality requirements that they might see are those associated with  US FDA and pharma research.

The approach that I plan to take this year is to frame Quality Management concepts as the only organized approach to prevent critical incidents.

In the clinical laboratory we define a Critical Incident as a result that is associated with inconvenience or harm to a patient that results from a faulty or significantly delayed report.  If we start from the perspective of harm, then perhaps an equivalent definition for a Critical Incident in the research laboratory is an event that results in the production of non-reproducible results that contributes to damage to the laboratory finance or reputation or credibility.

Personally I think this is a good starting point because it provides a basis for introducing Shewhart (Quality Control) and Deming and (PDSA  and Continual Improvement) and ISO 9001 (Training and SOPs, Document Control).   It also creates a basis for implementing programs for Cost of Poor Quality, since the Principal Investigator (PI) is responsible for monitoring grant funding.   And most PIs would consider it a sad point in their career  if the only jounal that would accept their data was the Journal of Irreproducible Results ©.

Phillip Crosby and DIRFT probably works better as a research laboratory concept than in either manufacturing or in service or in the clinical laboratory because the the environment and task-at-hand are easier to define and control, and the expectation of doing it right the first time is easier to implement.  One might argue that DIRFT has no place in the  trial and error process which is the fundamental raison d’etre of the research laboratory, if the procedure is executed properly as planned, then one has confidence that the result is credible, even if the result is negative.  If the process was done right the first time, the outcome can be both negative and positive at the same time.

And finally, it is critically important for this group of budding scientists to understand that quality is a performance issue, not an accreditation issue.  It would be reasonable for them to at least know there are ISO standards that can help their laboratories implement some form of cobbled quality system.

So that is the plan.  I will be interested in seeing how the students respond.

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