Positioning for Successful Quality Management System Implementation

The implementation of a strong quality management system (QMS) provides a platform for continuous improvement in service delivery:  enhancing customer service, meeting regulatory and accreditation assessments, and creating a culture of total service excellence.  The best contribution an organization can make to improve quality is to understand, document, and follow policies, processes, and procedures in their full complexity.  To establish a complete QMS, an organization needs to define the infrastructure known as the quality system essentials (QSEs) necessary to provide quality care to patients. The QSEs are the foundational building blocks that support the organization’s work operations, also called path of workflow.

Every service has a defined path of workflow, which represents the sequence of activities from the initiation of a request for a service through the provision of those services, and any necessary follow-up. In the clinical laboratory, the path of workflow begins with an order for a laboratory examination (test) and proceeds to provision of the report, and any necessary follow-up consultation. Each healthcare organization can use the same quality system essentials to manage its respective path of workflow, thus developing one universal set of policies, processes, and procedures for the quality system essentials that apply to all the services in the entire organization.

Essential Quality Management System Resources 

CLSI has recently released new editions of widely accepted “gold standards” of authoritative documents and products within its quality collection.  These documents, developed by recognized experts, provide guidance to ensure that clinical and healthcare organizations are functioning optimally to meet customer, regulatory, and accreditation requirements, and provide the highest level of patient care.

CLSI Quality System Toolkit (HS1-A2-C)
Based on CLSI document, A Quality Management System Model for Health Care; Approved Guideline—Second Edition (HS1-A2), this electronic product, which includes a PDF copy of the HS1-A2 document, provides information for designing, implementing, and maintaining an effective quality management system. The Quality System Toolkit lays the foundation for developing quality policies based on the 12 “QSEs,” controlling quality processes, and reporting and tracking occurrences.

In addition to the new toolkit, CLSI also offers a special discounted bundled collection of documents to meet targeted needs in its Quality Series (SC24-L) with the key documents for quality management activities.

Compliance Resources for Improving Quality

Technical aspects of a healthcare organization’s path of workflow are published in country-specific accreditation requirements. While each country will have its own requirements, they all have in common the need to define, document, and train for the organization’s activities. Laboratories and healthcare organizations that build accreditation requirements into their routine daily practice will always be well prepared for inspections and assessments.

CLSI provides an expansive collection of products to support implementation of a complete quality management system. Through its recognized consensus process, CLSI delivers the essential resources that organizations need to improve the quality of patient testing and healthcare services and to meet regulatory and accreditation requirements. CLSI serves as a resource to fill a gap where regulatory requirements are not currently in place, and provide practical recommendations and practices to meet regulatory requirements.

Upcoming Procedure Manual Document and Toolkit Support a Quality Management System and Compliance Needs

CLSI will soon release new editions of its procedure manual standard and toolkit:

The newly revised Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition (GP2-A5), scheduled for publication in late March 2006, has been updated to include: examples of the use of process flowcharts to depict linkages between laboratory procedures; elements for writing process and procedure documents for preexamination, examination, and postexamination activities; information about writing procedure documents for multitest automated analyzers and for laboratory information systems; and the eight elements of document control.

CLSI Procedure Manual Toolkit (GP2-A5-C)
This toolkit, scheduled for spring distribution, presents the major concepts of document development and control. Included in the toolkit are nine templates that provide the framework for developing procedures and communicating and organizing information. It also includes a PDF of the revised, approved-level document GP2-A5.

At a special discount, CLSI also offers GP2-A5 as part of the bundled collection of documents, Regulatory Compliance (SC31-L), which includes documents that will help laboratories comply with regulatory requirements.

Partners to Promote Excellence in Performance

CLSI consistently maintains open communication with regulatory and accreditation organizations and it partners with them for the mutual goal of providing the tools needed to improve the quality of patient care. In November 2005, CLSI and COLA announced a partnership directly linking best practice standards, guidelines, and educational services to regulatory compliance and laboratory accreditation. Similarly, numerous CLSI documents are referenced in the College of American Pathologists (CAP) Laboratory Accreditation Program Inspection Checklists and serve as key resources for helping laboratories to satisfy accreditation requirements. During CAP’s on-going process of updating accreditation checklists, the associated reference lists will be updated with the most recently published editions of CLSI’s standards and guidelines.

Global Initiatives Provide a Complete Approach to Quality Programs

CLSI has developed the “how to” tools for implementation of quality requirements prescribed by the International Organization for Standardization (ISO). ISO 9001 defines a process model for quality that any business should use to manage its operations, ISO 17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling, and ISO 15189 defines standards for quality management in the medical laboratory environment.

The primary objective of ISO 15189 is to create the foundation for quality in medical laboratory services. CLSI quality guidelines provide practical approaches to facilitate organizational execution of the requirements prescribed in ISO standards and aid in the successful implementation of a quality management system. CLSI’s series of quality management system guidelines complement the efforts of ISO 15189 to provide a comprehensive quality management system approach for medical laboratories worldwide.

ISO 15189 does not substitute for US government regulatory requirements such as the CLIA ’88 legislation; however, alignment with ISO 15189 by various US accreditation agencies, such as COLA and CAP, and the establishment of ISO 15189 as the primary national standard for laboratories in many other countries around the world, strengthens the importance of this international standard. ISO 15189 is increasingly becoming the overriding, uniform global approach for quality and competence to which clinical laboratories and healthcare services aspire.

CLSI Commitment to Quality

With the rapid evolution of techniques, tests, methods, and technologies in the healthcare industry, CLSI continues to respond with the essential resources and vital guidance to improve quality management, assure patient safety, and achieve success. Through the development of new quality documents and products, ongoing efforts to forge partnerships with government and accreditation bodies, and harmonization with key ISO standards, CLSI equips organizations worldwide with the tools to provide consistent, compliant practices and efficient use of resources. Undoubtedly, CLSI embraces its commitment to advance quality in healthcare testing now and in the future.

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