LQMS – Introduction Lesson Voiceover Transcript

April 2020                LQMS – Introduction Lesson Voiceover Transcript        Page  of

Slide 1                Introduction to the CLSI Laboratory Quality Management System Certificate Program

Welcome to this first lesson of the CLSI Laboratory Quality Management System Certificate program. This lesson introduces you to the CLSI laboratory Quality Management System—abbreviated as QMS—and explains how your laboratory can use the QMS to improve quality and directly affect patient safety. In this lesson you will also learn how the certificate program is organized.

Slide 2                Learning Objectives

This slide displays the learning objectives for this introduction lesson. Following this lesson, you will be able to:

1. Describe how CLSI derived the model for implementing a laboratory quality management system.
2. Diagram the model structure and explain its parts.
3. Distinguish between the roles of quality control, quality assurance and QMS.
4. Discuss the advantages of having a laboratory QMS.
5. Describe the four different types of quality costs.
6. And lastly, explain how this certificate program is organized..

Slide 3                Some Requirements for a Laboratory

Let’s look at typical requirements for laboratories.

• There are international requirements for laboratories in every country such as those found in ISO 15189 and ISO 17025 and the World Health Organization WHO.
• There are national requirements for laboratories and transfusion services, such as the United States Clinical Laboratory Improvement Amendments of 1988 and Good Manufacturing Practice found in developed countries.
• There are safety requirements that affect laboratories such as the United States Occupational Safety and Health Administration, abbreviated as OSHA.
• There are national and international requirements for transportation of biohazardous materials such as those by the United States Department of Transportation, abbreviated as DOT and the International Air Transport Association, abbreviated as IATA.
• There are also internationally applied accreditation requirements, such as those published by the Institute for Quality Management in Health Care, The Joint Commission, the College of American Pathologists, the AABB, the  former American Association of Blood Banks, and COLA, the former Commission on Office Laboratory Accreditation.
• The important dilemma for laboratories anywhere is how to make sense of all the various requirements imposed on them. Can we make sense of them?

Slide 4                A Generic Management Foundation

CLSI refers to the documents published by the organizations shown on the previous slide as “the bedrock documents” because they form a solid foundation of regulatory and accreditation requirements for medical laboratories.

• This bedrock foundation is shown as the purple bar at the bottom of this slide.
• The national and international regulatory requirements that apply to medical laboratories are shown on this list and correspond to the ones shown on the previous slide.
• The international and national voluntary hospital and laboratory accreditation organizations are shown on this list.

This is a very large number of organizations that have requirements for laboratories! This is a huge number of requirements that laboratories must fulfill to provide quality services for patients and other customers!  

Slide 5                Some Requirements for a Laboratory

Is it possible for a single laboratory or a laboratory system to have a single program for managing quality that includes all the applicable requirements?

• The answer is yes. We can make sense of the requirements — by sorting them into common elements.  On the next slide you’ll see how this was done.

Slide 6                CLSI Sorted the Requirements

In the late 1990s, CLSI—then known as NCCLS—convened a workgroup to develop guidance for laboratories on how to implement a quality management system.

• We made photocopies of the published requirements for laboratories. We really did use scissors to cut each statement, clause, or numbered item.
• Each item was sorted by topic—such as personnel, equipment, safety, documents, and so on. For example, all the organizations have published requirements that the laboratory conducts personnel training. All the replicates were then removed.
• What remained was the single set of elements that covered all requirements for that one topic.
• The elements were arranged in the order in which they occurred in the laboratory. For example, each instrument and piece of equipment has a life span. Your laboratory selects, procures, installs, uses, maintains, and retires equipment—in that order.
• Each topic was given the heading of Quality System Essential—abbreviated as QSE—…
• …and a name representing its topic. For example, QSE Personnel Management, QSE Documents and Records Management, QSE Equipment Management, and so forth.
• The QSEs were then arranged in a logical order. This is the order to consider when starting a new laboratory, a new section within a laboratory, or new laboratory examinations—or, when changing a laboratory service or process.

Slide 7                QSE: All Requirements for One Topic

When the sorting was finished, 12 topics emerged - as shown on this slide. This CLSI Laboratory Quality Management System Certificate Program contains one lesson for each of the 12 QSEs. You will learn about the requirements for each QSE and suggested ways to fulfill the requirements in your laboratory.

This common framework for laboratory requirements is significant for the following reasons:

First, the past two decades has proven that any requirement ever written for laboratories or ever will be written in the future will fit into one of these QSEs. Thus, this common framework will remain unchanged into the future. As new international and national requirements are added or requirements are modified or changed, CLSI incorporates them into revisions of guideline QMS01 so that the QSEs always remain current.

Second, it’s easier and more organized to develop and implement policies, processes and procedures for the requirements of a single QSE than to have these documents for individual regulatory or accreditation requirements. Thus, managing quality in this type of framework ensures that your laboratory will meet requirements of any of the organizations from which the source requirements were taken.

And third, when all personnel follow the QSE policies, processes, and procedures that describe and guide their work, your laboratory will be generating the objective evidence needed to demonstrate to any of the regulatory or accreditation organizations that the requirements are being met.

Slide 8                What About Laboratory Examinations?

Requirements in the source documents were also sorted for the laboratory’s various technical processes—referred to as pre-examination activities, examination activities, and postexamination activities.

This slide expands the laboratory’s technical activities—called the path of workflow—into greater detail.

• Pre-examination activities commence when a practitioner orders a laboratory examination for any laboratory discipline. Preexamination activities then flow through specimen collection, transport to the laboratory, receipt in the laboratory, accessioning into the laboratory information system, whether paper or electronic, any initial specimen processing, and then distribution of specimens into the examination areas.
• Examination activities include testing by manual or automated testing systems that use qualitative and quantitative methods and microscopy, and also results review, follow-up, and any interpretation.
• Post examination activities include reporting results on paper or electronically, archiving the results, and archiving the specimen material.
• The path of workflow applies to all laboratory disciplines, including anatomic pathology and cytology.

All laboratories of any size, scope, specialty, or complexity have the same path of workflow, making it another generic element of laboratory quality management.

Slide 9         The CLSI QMS Model

The QMS model shown on this slide is the final result of CLSI’s sorting and organizing of laboratory requirements. It’s important to understand that this model does not contain requirements for laboratories that are different from what is in the “bedrock” reference documents. Instead, the model has simply sorted the already-published standards and requirements for laboratories into a set of easily recognized topics.

• First, international and national documents contain requirements for laboratories. The requirements are represented here as the “bedrock” foundation for the laboratory’s quality management system.
• On top of the foundation are placed the building blocks of quality, which we now call the QSEs. A solid quality foundation means that your laboratory follows established policies, processes, and procedures for the QSEs so that the requirements are fulfilled.
• Your laboratory’s path of workflow consists of the pre-examination, examination, and post examination activities that transform an order for a laboratory examination into results and reports.
• The path of workflow is the same for all laboratory disciplines such as the traditional ones shown here, and any new disciplines in the future.

The QSEs serve as the management foundation for all disciplines in the path of workflow. When a QSE is missing or not well implemented in your laboratory, problems will occur in the workflow. For example, when your laboratory’s specimen receiving personnel are not well trained or sufficiently competent—which are requirements in QSE Personnel Management—your laboratory will have to rectify data entry errors, acceptance of unacceptable specimens, and specimens being improperly aliquoted before examination.

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