Example Materials for Educators

Need for Internet Training Courses in Quality Management

Quality is still an issue in laboratory testing, in spite of the continuing improvements in analytical methodology and instrument systems. While there is increasing attention being given to the pre-analytical and post-analytical parts of the testing process, there are still problems with the analytical part of the process.

For example, method validation practices still suffer from the improper use of statistics in assessing the imprecision and inaccuracy of an analytical method, as discussed in a recent editorial in the Clinical Chemistry journal [1]. We studied some of these problems 25 years ago [2] and published detailed recommendations for the use and interpretation of common statistical tests. For the most part, similar problems exist today, illustrating that there has not been much improvement in the basic statistical knowledge and skills available in laboratories today.

Anne Belanger, writing in Medical Laboratory Observer, cited quality control problems as one of the most frequent deficiencies identified by JCAHO laboratory inspections [3]. "Lack of corrective action for out-of-range QC and PT has been on JC's top five most frequently cited standards list for the past 18 years." She identifies two reasons for this continuing problem. "(1) Corrective action is not always easy or convenient to perform. It takes thought and analysis, and documentation can be laborious. (2) Some testing personnel have forgotten the fundamental reason for QC: to pinpoint when testing processes are not functioning optimally."

In the May 1998 issue of the ASCLS Today newsletter, Diana Mass discussed the changing skills of analysts in healthcare laboratories and identified the ongoing need for highly skilled clinical laboratory scientists. "It is a fact that technology has created instrumentation and test methodologies that do not require the performance of very complex tasks. However, the knowledge and skills necessary to perform quality control and to validate test results still require a greater cognitive aptitude" [4]. She also pointed out there is a potential shortage of highly skilled laboratory scientists due to the ongoing closings of CLS programs.

Quality control practices are also changing. The practice of using the same QC procedure for all tests and methods is being replaced by analyte specific rules, which need to be selected on the basis of the quality required for the individual test and the precision and accuracy observed for the method in the individual laboratory. This requires new skills in the planning and design of QC procedures - skills that are beyond the current education and training of most clinical laboratory scientists.

These skills are critical for improving quality management and meeting the new guidelines for quality control practices that are being recommended by the National Committee for Clinical Laboratory Standards (NCCLS) in the newly revised C24A2 document "Statistical Quality Control for Quantitative Measurements: Principles and Definitions" [5].

It is difficult to see how these basic quality issues can be resolved without additional training and education. As CLS training programs continue to close due to the tight budgets of academic institutions, the training will be shifted to manufacturers and the laboratory itself. However, according to Mass [2], most training courses offered by a manufacturer's technical support service do not provide these higher cognitive skills. That leaves it up to the laboratory's own in-service training, which is already stretched by needs for cross-training as the workforce is cut back through reorganization, restructuring, and reengineering.

One approach for addressing these training and education needs is to develop Internet training materials and courses that can be made available anywhere and anytime, therefore fitting the location and schedule of the learner who may be participating in an educational program or who may already be on the job. Some elements of an Internet training course are illustrated here to show the possible structure of a course, the format of a lesson, and example training materials.

Process for Developing an Internet Course

The development of an Internet course is like writing a textbook. It's a lot of work and will require a lot of organization and persistence to complete the task. Unlike a traditional lecture course where the time and effort is expended in the preparation and delivery of lectures as the course progresses, all that time and effort must be spent up-front when developing an Internet course. However, once the course is completed, it should takes less ongoing effort and students will be able to proceed at their own paces and with some flexibility in how and when they study the materials.

The steps of the process are shown in the accompanying flow diagram. The first step is to identify the target audience and their needs. Then the contents and approach should be outlined in an initial draft of a course description that includes objectives, contents, and a plan for organizing the studies. This material provides a "course-page" for the Internet course.

Next you have to acquire or prepare the training materials. It may be possible to access existing materials just by adding "links" that the student can "click" to get the materials. Other materials may need to be written and developed from existing lecture notes or from new lesson outlines.

These course materials are organized by lesson plans that provide the links to the materials. A lesson plan should state specific learning objectives, identify and provide links to the course materials, describe the learning activities expected of the student, and also provide some way of assessing what the student has learned, either by self-assessment questions with answers, problem sets with answers, or quizzes graded by computer.

The lessons are organized by creating a syllabus that identifies all the individual lessons and provides links to the lesson plans. This syllabus can be password protected to control access to the course materials.

Once the syllabus is ready, the course page can be finalized and linked to a registration process. With completion of the registration process, the student would obtain the password to access the course syllabus and course materials.

Implementation of the course will generally require an on-line discussion forum, a mechanism to monitor student access of training materials and to interact with individual students as necessary to promote their progress through the course, an online mechanism to administer student exams, and a course evaluation process that includes feedback from the students. The availability of this "infrastructure" may be one of the factors that determines how quickly an Internet course can be implemented today.

References

  1. Westgard JO. Points of care in using statistics in method comparison studies. Clin Chem 1998;44:2240-2242.
  2. Westgard JO, Hunt MR. Use and interpretation of common statistical tests in method-comparison studies. Clin Chem 1973;19:49-57.
  3. Belanger AC. The Joint Commission and CLIA: A 5-year retrospective. Medical Laboratory Observed 1998;30(2);46-48.
  4. Mass, D. A call to arms. ASCLS Today 1998;12(5).
  5. NCCLS C24-A2: Standard Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guidelines - Second Edition. National Committee for Clinical Laboratory Standards, Wayne, PA, 1999.