Improving Quality with NCCLS Consensus Documents and Products

Leading healthcare professionals around the world are implementing quality practices to improve their organizations. This commitment to quality laboratory and healthcare services increases patient safety, reduces error, eliminates waste, improves performance, enhances customer and employee satisfaction, and increases profitability. As economic and resource pressures build, a global view of internationally accepted quality activities is necessary. On an ongoing basis, laboratorians and professionals in the healthcare community must ensure that patients’ needs are being met by safe, effective, and timely healthcare services. In order to continue to evolve and implement quality systems, dynamic supports, references, and guidance are essential.

How Do NCCLS Documents Improve Quality?

NCCLS’s quality management system model works to strengthen quality initiatives by addressing services’ paths of workflow from beginning to end. A path of workflow is the description of the necessary steps to deliver the particular product or service that the organization or entity provides. All services follow these processes to deliver quality information.

NCCLS’s documents aid an organization’s implementation of quality assurance programs by providing guidance for standardized testing procedures from the initial (pre-examination) stages of specimen collection, handling, and transport, through the intermediate (examination) stages, to the final stages (post-examination) of recording and interpreting the results; supplying references which help in the verification of test performance and ensure the reliability of results; and delivering tools to ensure appropriate specimen collection and preparation techniques, validation of test results, and appropriate quality control procedures. Overall, NCCLS’s documents and products serve as a much needed asset in achieving improved healthcare quality and, ultimately, reducing medical errors.

The Quality System Management Approach

Quality requires a systematic approach which defines the organizational structure, resources, processes, and procedures needed to implement quality management. A quality management system defines how the processes interrelate departments and services. Instituting a quality system approach should, by design, build quality into the workings of a clinical laboratory or any other healthcare service. The implementation of a quality management system approach is increasingly critical for organizations to facilitate licensure, satisfy accreditation, build credibility, reduce operating costs, and achieve success.

NCCLS subscribes to a quality management system approach in the development of standards and guidelines. This approach facilitates project management; defines document structure via a template; and provides a process to identify needed documents through a gap analysis. NCCLS document HS1-A, A Quality System Model for Health Care, provides the infrastructure for developing a quality system that will meet the quality objectives of a healthcare service;  and GP26-A2, Application of a Quality System Model for Laboratory Services , is an application document of the quality system approach for the clinical laboratory.

These documents, specifically related to quality systems, parallel the efforts of ISO 15189, Medical laboratories – Particular requirements for quality and competence. When used in conjunction with ISO 15189, these documents provide medical laboratories with specific tactics for implementing quality guidelines. Accordingly, all NCCLS healthcare services documents strive to meet the same generic ISO standards, including the ISO 9000 series and ISO/IEC 17025:1999, General requirements for the competence of calibration and testing laboratories (formerly ISO/IEC Guide 25).

Using the NCCLS Model: HS1-A — A Quality System Model for Health Care and GP26-A2 — Application of a Quality System Model for Laboratory Services

HS1-A — A Quality System Model for Health Care sets out a structured approach to organizing, creating, and maintaining information (defined by an organization’s policies, processes, and procedures) to help eliminate "gaps" in an organization or service’s processes and to guide organizational quality improvement efforts. This guideline provides a structure for a comprehensive, systematic approach to build quality into the healthcare service’s processes, assess the service’s performance, and implement quality improvements.

The document includes 12 “quality system essentials” or “QSEs.” Information is provided about the processes and procedures that a healthcare organization or service needs to have in place to ensure that its work operations are functioning as intended to meet customer, regulatory, and accreditation requirements, and to provide for the highest level of patient safety.

GP26-A2 — Application of a Quality System Model for Laboratory Services provides the necessary background information and infrastructure to develop a quality system that will meet a laboratory’s quality objectives and be consistent with the quality objectives of an institution. Specifically, it lays the foundation for defining all activities of the overall management function that determine quality policy objectives and responsibilities; and for implementing them by means such as quality planning, process control, quality assurance, and quality improvement within the system.

In addition to GP26-A2, NCCLS documents HS4-A, Application of a Quality System Model for Respiratory Services; HS5-A, Application of a Quality System Model for Medical Imaging Services; and HS10-P, Application of a Quality System for Inpatient Medication Use are intended for use with HS1 when developing an organization’s quality system. These documents describe various QSEs and paths of workflow for maintaining quality in the specific disciplines of respiratory services, medical imaging services, and inpatient medication use.  

NCCLS is currently revising documents HS1 and GP26. The working group is incorporating a global view of internationally accepted quality activities applied to a given scope of work. The anticipated availability date for the revised publications is November 2004.

A healthcare quality system describes, documents, implements, measures, and monitors the implementation and effectiveness of the work operations of any service unit or support operation in the organization. It provides a means to direct and control an organization with regard to quality. The NCCLS model sets out a structured approach to organizing, creating, and maintaining the necessary information for implementation and effectiveness of work operations, so all employees know how the organization functions and of its commitment to quality.

Future Quality Initiatives

In order for quality initiatives to succeed, organization decision-makers must be committed to their success, and all organization employees must understand that they are part of the solution and have a role to play in ensuring a quality program. By focusing on its mission to facilitate the development and availability of useful, effective, global consensus best practices, NCCLS provides the healthcare community with a valuable tool to achieve a high level of quality patient care.

For more information and future developments about the NCCLS Quality System Approach, visit http://www.nccls.org or call the NCCLS Executive Offices +610.688.0100. [ return to top ]