Sunday, January 9, 2011

Quality and Laboratory Medicine - Who is in charge?

As I continue with the Resident and Graduate Student seminar series, I have a dilemma.  I did a pre-course survey, in part to develop an objective measure of the course effectiveness in transferring knowledge. 
One of the questions asked in the survey was “When implementing a Quality System in a medical laboratory the single most critical procedure is “. 
The responses provided included:
     Regular and Frequent Management Review
     Regular Internal Audits
     Document Control
     Developing and Maintaining a Procedure Manual
     Regular Accreditation Assessments
     Robust and Regular Quality Control
     All included.

Only one answer (Regular and frequent management review) was deemed as the correct answer.  Of interest of 26 responses to the question, the number selecting that answer was zero.  The most common response was “all included” which was probably a poor inclusion on my part, but that does not take away from the absence of recognition of management as arguably the most critical part of implementing a quality system.

I don’t have to reiterate Deming’s stories about the importance of management to quality, because everyone interested in Quality knows and understands that to Deming, the absence of interest by top management results in failure to establish quality.  It is relevant that in the book “Out of Crisis” he makes the point that Management is responsible for 94% of error.  
Feigenbaum also made the point in Total Quality Management  when he said that by using the slogan “quality is everybody’s responsibility” we ensure that quality is “nobody’s” responsibility.  Quality is somebody’s responsibility and that somebody is Top Management 

I should not be too surprised that a group of residents in pathology and laboratory medicine would fail to recognize the importance of management in quality,  because most training programs do not have a tradition of recognizing how much of the work they will be doing will be management.   This is an excellent example of systemic failure.

Not to overstate the case (well maybe to overstate a lot!) laboratory chairs who feel it is acceptable and  appropriate to “game” or ignore accreditation and proficiency testing are unlikely to see a value and purpose in establishing quality management as a key component of their own laboratory or as a component of resident training.   To them quality is solely an operational responsibility, somebody else’s job.  In those laboratories that may well be the case.   

Pathology and Laboratory Medicine may well be at a cross-roads.  I wonder which path we will take.


  1. Hello Dr. Noble,
    I took the LQM course a couple of years ago, and I have two questions for you:
    1) Could you make me a Linked in connection (my info can be found at
    2) Do you think one of the problems lab medicine has is that we don't stress who are clients (ie in this order, patient, Doctor, Nurse, myself, management)? One gets the impression that patient, Doctor, Nurse are viewed as inconvinences instead, and that management is the primary customer.
    Mark Hawkins

  2. Quality Management Systems demand that the organization monitor customer satisfaction, which means that they need to know who their customers are.
    In the retail business or in industry, the organization can lean the hard way when customers needs are not being met. They stop coming in the door. In health care we see this as well, but less so in North America. Here what we see is that when the customer is REALLY unhappy they go to the media, or the Ministry, or their lawyer.

    There may be some advantage in prioritizing the customer list, but when the "bad thing" happens, regardless where it came from, it is too late.


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