The fourth edition of Quality Management System: A Model for Laboratory Services (GP26-A4) goes beyond laboratory quality assurance and control to focus on a broader systems approach to manage quality. The revised guideline, developed by the Clinical and Laboratory Standards Institute (CLSI), provides a framework for managing the laboratory’s path of workflow in an integrated model based on 12 quality system essentials (QSEs). “This important advancement is designed to ensure that the laboratory’s quality management system (QMS) drives the highest quality of patient care,” explained Jennifer Rhamy, MBA, MA, MT(ASCP),SBB, HP Executive Director, Laboratory Accreditation Program, The Joint Commission, and a participant of the working group that revised the guideline.
Key Changes in GP26-A4
The QSEs and the laboratory’s path of workflow are combined; in previous guidelines (HS01-A2 and GP26-A3) they were addressed separately. This unification highlights the focus on integration between these 2 key aspects of the QMS.
GP26-A4 was aligned with new or changed standards and accreditation requirements for clinical laboratories, including those from the International Organization for Standardization (ISO), the Clinical Laboratory Improvement Amendments, the College of American Pathologists, COLA, and The Joint Commission.
New or enhanced supporting documents and forms were added.
The revised guideline reflects the maturation and growth of QMS concepts and knowledge within the clinical laboratory field. It describes best practices in laboratory management, as determined through a rigorous consensus process involving a wide range of subject matter experts.
The QSEs were reorganized in this edition to more logically support the components of the QMS and to highlight the importance of leadership responsibilities for laboratory quality, reduction of medical errors, and more effective and efficient laboratory operations. “Labs must have committed leadership to have a thriving and successful QMS,” said Tania Motschman, MS, MT(ASCP)SBB, CQA(ASQ), Regulatory and Accreditation Manager, Mayo Clinic, and vice-chairholder, (Standing) Subcommittee on Quality Management Systems.
The QSEs function as the building blocks to support the path of workflow and various laboratory disciplines (see Figure 1, The Quality Management System Model for Laboratory Services). These building blocks provide the means to ensure that the laboratory meets its commitment to quality throughout its pre-examination, examination, and post-examination processes. This integrated approach extends beyond the laboratory’s borders to ensure that departments and entities with touch points to the laboratory, as well as the organization’s overall QMS, are considered in its quality program.
For each of the QSEs, a table summarizing the major requirements for policies, processes, and procedures is provided. The QSEs (in order as they appear in the revised guideline) are:
Organization—describes key leadership responsibilities that are integral to the laboratory’s success. This edition places greater emphasis on the importance of this QSE, especially leadership commitment, effective implementation, and communication. Quality planning and integration of QMS activities are key elements of QSE Organization.
Customer Focus—describes the laboratory’s identification of its customers and their expectations, the need to design work to meet those expectations, and the activities needed to follow through and ensure that those expectations are continually met.
Facilities and Safety—provides greatly expanded information about the laboratory’s physical environment and the maintenance and safety programs needed to support it. Emergency management is a key element of QSE Facilities and Safety.
Personnel—similar to what was contained in the previous edition, this QSE describes the processes needed for obtaining and retaining an adequate number of qualified, well-trained, and competent laboratory staff.
Purchasing and Inventory—describes agreements between the laboratory and entities to which it provides services, as well as with those from which it obtains products and services. The instruction surrounding this QSE is also similar to that of the previous edition.
Equipment—provides expanded information on equipment qualification, including the selection and installation of equipment, and operational and performance qualification.
Process Management—describes the management of processes directly and indirectly related to the laboratory’s path of workflow, including those processes that support the QSEs.
○ Information on validation and verification of processes was expanded in this edition, as was the section on change management requirements.
○ The concept of “measurement uncertainty”—the impact of variability or uncertainty on laboratory results—was introduced as a best practice.
Documents and Records—describes the creation, management, and retention of documents for the QSEs and path of workflow, as well as records generated from performing the activities of the QMS. The instruction surrounding this QSE is similar to that of the previous edition.
Information Management—provides guidance for managing the information generated and entered into paper-based or electronic systems and disseminated to users or other computer systems. Requirements for planning for information needs and for ensuring confidentiality of information were enhanced in this edition.
Nonconforming Event (NCE) Management—in this edition, the management of NCEs is defined as a program that includes the processes for detecting and documenting nonconformances, managing products and services that do not meet specified requirements, classifying nonconformances for analysis, and correcting the problems they represent. This edition introduces the need for a recall process for the laboratory’s own products and services.
Assessments—describes the use of assessments to verify that laboratory processes meet requirements and to determine how well those processes are functioning.
○ A section on peer review for blood utilization and transfusion services has been added.
○ The use of quality indicators has been enhanced. Quality indicators are essential because they provide evidence that quality goals are being met. They are used to establish baseline information for measuring improvements, and they can help to understand laboratory performance compared to historical performance and internal benchmarking, other laboratories, and even other industries. While no single set of indicators is required or even recommended, more examples of quality indicators (see Appendix Q) and references to published laboratory quality indicators (see Appendix R) have been added.
Continual Improvement—describes the mechanisms for identifying opportunities for improvement and use of a defined strategy for continual improvement and effectiveness. A section on participation by the laboratory in organization-wide improvement in areas relevant to patient care and outcomes was added.
Other Benefits of the Updated Guideline
“The guideline is considered to be quite user-friendly,” said Harriet R. Walsh, MA, MT(ASCP), Deputy Director, Laboratory Services, Centers for Medicare & Medicaid Services, and Member of the (Standing) Subcommittee on Quality Management Systems. “Terminology has been standardized throughout; the use of ‘needs to’ indicates an action that can be traced to a regulatory or accreditation requirement, while the uses of ‘could,’ ‘should,’ and ‘recommended’ indicate best practices. Thanks to its ease of use and its alignment with a variety of laboratory regulations and accreditation standards, following GP26-A4 is expected to help laboratories more easily ensure compliance with these requirements.”
Appendix materials have been added or revised to provide additional information for implementing the guideline. These include:
Mapping of the QSEs to ISO standards 15189:2007, 17025:2005, and 9001:2008
Examples of a validation protocol, a software validation worksheet, and an audit report form
Updated record retention schedule and NCE report forms
Greatly expanded list of quality indicators
Guidelines for the implementation of a QMS in the laboratory are found in Section 7. The first step is to perform a gap analysis, followed by a plan to close the gaps. A phased approach is recommended, based on the specific and unique needs and priorities of the laboratory.
What Are the Anticipated Challenges to Implementation?
“While specialized training on the guideline may be helpful, it is not expected to be necessary, given the clarity and ease of use of the guideline,” said Motschman, who has already conducted training on GP26-A4. “The challenge to implementation may instead come from the need for a shift in thinking and lab culture to a more integrated model.” According to Rhamy, “The larger, more macro view of systems management, as defined in the document, may be new to labs accustomed to working in silos. Fortunately, many labs already have some level of systems thinking.”
Renumbering of the QSEs may not match laboratory document numbering if based on the previous listing order. Actual numbering is not critical and does not have to be changed; the laboratory may wish to map its QSE order to the new numbering scheme to show that all are covered.
While a highly functioning QMS will support the most efficient use of resources, there is a necessary investment of resources to design and implement a system that meets the guideline. Without the leadership and organizational structure needed to dedicate these resources, implementation will likely be more challenging.
“The integrated system of path of workflow and QSEs described in GP26-A4 will help labs meet their goals for high-quality lab results providing the best quality patient care, and will help to develop greater confidence in the lab,” said Walsh. What better reasons are there to implement this guideline?
Tania Motschman, MS, MT(ASCP)SBB, CQA(ASQ), is the Regulatory and Accreditation Manager for the Department of Laboratory Medicine and Pathology at the Mayo Clinic, Rochester, MN.
Jennifer Rhamy, MBA, MA, MT(ASCP)SBB, HP, is the Executive Director of the Laboratory Accreditation Program at The Joint Commission, Oakbrook Terrace, IL.
Harriet R. Walsh, MA, MT(ASCP), is the Deputy Director for the Division of Laboratory Services at the Centers for Medicare & Medicaid Services, Baltimore, MD.