Friday, June 2, 2023

Giving Back and Paying Forward - 2023

In the sciences, Quality is NOT about Elegance or Specialness or Brilliant Ideas. Quality, especially in laboratories, is defined by the specifics of meeting requirements and performance. Quality provides the cornerstone for confidence through error awareness and prevention for precision, accuracy, and reproducibility, and relevance. 

The Quality Tools are essential in medical laboratory research and performance.  People's lives may depend on laboratory information.  Done well, laboratory research promotes new knowledge, new understandings, new vision.  Done poorly, it wastes time, wastes money, wastes resources, and creates harm.

I would like to think that understanding the importance of Quality is innate, but that would be expecting too much, but it most certainly is a skill that can be learned and passed on from one-to-another. 

Our university department is quietly worked at promoting laboratory quality improvement through the creation and management of 3 separate laboratory quality assessment (PT/EQA) programs, one in microbiology, one in clinical chemistry and one in tumor marker testing, all of them active in across Canada and international. We created an intense program for assisting countries already with EQA programs how to upgrade their offerings to link their programs with the expectations cited in ISO15189 (ISO15189 does NOT specify the requirements of EQA, but it does point out what medical laboratories should be expecting and looking for in EQA programs). And most recently we have been working with another program to help developing countries develop more EQA tools for their local laboratories, thus freeing themselves of the foreign programs with large costs and little relevance. 

This was not the career that I envisioned when I started my laboratory training in 1975, but I personally feel much pride in carving out was has turned out to be a very successful path for myself and for laboratory quality. I am thankful for having had the opportunity to work in a truly inspiring field,  and am proud of what I have been able to do to influence and (hopefully) inspire hundreds of students. 

So now I am starting on a new path of giving back and of paying forward. Over the last year we have developed the Michael A Noble and Family Award in Laboratory Quality which is founded on a sustained endowment to our department to highlight and reward Quality focused projects and presentations of graduate students and medical residents and course takers in our department. Last night we presented our first award to a student who has been looking at factors that can impact the survival of donor platelets, necessary for people with bleeding due to severely low platelet counts (thrombocytopenia). 

By highlighting projects and presentations that lead to new understanding and knowledge and insights in Laboratory Quality and Improvement we can help lead to further advances in Pathology and Laboratory Medicine. More importantly (in my opinion) through this recognition, we can spawn lifelong commitments to addressing and highlighting and embracing laboratory quality as an essential component of laboratory discovery. 

We look forward next year's Pathology Day 2024.

Sunday, April 23, 2023

Human Performance Errors (HPEs) and EQA


I am in the midst of an interesting career that started simply enough by being a laboratory physician, but over time has taken me to into areas that I did not anticipate which included working in laboratory quality from multiple directions. 

In the early 1980s I got involved in developing an External Quality Assessment or EQA program (also known as proficiency testing) which was designed to help laboratorians and accreditation bodies be better aware of human performance errors (HPEs).  That led me towards an active career in all aspects of laboratory quality from standards development to quality management training and then to teaching.  Some would say that sounds like a backwards direction.

 In any event, HPEs are a big problem, not only in laboratories, and usually all work sites.  They either result from slips or distractions, or from mistakes associated with knowledge or procedures failure.  The former are frequent, but often intermittent and inconsistent.  The latter are more likely to be repeated or at least repeatable.  These repeatable HPEs are often associated with poorly written Standard Operating Procedures, or unclear unmonitored training which can result in gaps in knowledge and understanding.  These are Human Performance Error, but while the error may be detected in the work of the technologist/performer, but the REAL PROBLEM is the person who did the insufficient training or wrote the insufficient SOP, i.e. these are management caused systemic errors.  This is not a new finding.  Almost all people who look at error (Deming, Juran, Crosby, Dekker) all say the same thing, management errors cause more harm and more significant harm, but rarely get included in error reports.  (The Pen is More Dangerous than the Wrench)

HPEs differ from equipment or reagent errors.  Equipment and reagent errors can be detected and prevented by a solid Quality Control program.  HPEs can be detected by EQA, especially when they are repeated or repeatable, and silent, meaning that they didn’t show up during an bad event investigation. 

When people are presented with samples that closely simulate typical samples whose content is unknown to the tester, but known by the provider, and error can be captured by the external results evaluator.  This is clearly better than having the error detected after a patient is harmed.

The external evaluation is an essential part of the exercise, because it shines a light on the problem in a way that internal evaluation by itself may not.   When the reviewer is external (as with EQA) there is no motivation to not report the problem… there is no reason to hide missed performance.  It makes EQA the most objective form of testing to detect HPEs in laboratories.

Not everyone likes the idea of being monitored for error and may find ways to escape scrutiny.  During a recent presentation that I gave, a person in the audience said that laboratories would do better if instead of developing programs like EQA, they would develop better techniques so that that errors would not happen.  I disagreed.  I don’t think there is any plan that will prevent all errors.

I noticed with interest that the International Organization for  Standardization (ISO) does not agree either.  The newest version of ISO15189:2022 on Quality and Competence in the medical laboratory expects laboratories to enroll in EQA programs that not only look for human performance during examination testing, it also specifies looking at performance in the pre-examination (between the collection of the sample and it being received in the laboratory) as well as the post-examination  (starting to creating the record or report and ending with contacting the physician).  At the present time I would guess that only about 20 percent of EQA organizations can provide today, so good on the ISO for writing standards that should push program development.