more information or may receive an on-site visit. If no problems are identified, the laboratory receives recertification for a 2-year period, provided that all relevant fees are paid. The certificate is forwarded to the laboratory. No laboratory will go longer than 4 years without an on-site survey. Approximately 5% of the laboratories are visited on-site to verify the effectiveness of this self-survey process.
The performance-based survey is a reward for exceptional performance and an incentive for improvement for those laboratories that have not yet been granted permission to use this self-survey approach. General information regarding the survey process can be obtained by calling Judith Yost (Director, Center for Laboratories, Health Standards and Quality Bureau) at HCFA [(410) 786-3531] (58).
Currently, there are ongoing efforts at both the national and international levels to provide guidelines for clinical laboratories in order to upgrade their QC and quality assurance programs to a broader definition—that of quality systems. Where QC and quality assurance programs monitor performance aspects of very specific operations, a quality system applies universal quality elements throughout the entire operation of the laboratory.
The application of Lean management systems to laboratory medicine is becoming more relevant. Lean is the term used to describe a principle-based CQI management system based on the Toyota production system that has been evolving for the past 70 years. Its origins were heavily influenced by the work of W. Edwards Deming and the scientific method that forms the basis of most quality management systems. Lean has two fundamental components: a systematic approach to process improvement by removing waste in order to maximize value for the end-user of the service and a commitment to respect, challenge, and develop the people who work within the system to create a culture of continuous improvement. Lean principles have been applied to many health care systems throughout the world to improve the quality and cost-effectiveness of services for patients. Also, a number of clinical/pathology laboratories have used Lean to shorten turnaround times, improve quality (reduce errors), and improve productivity. Increasingly, models designed to implement large-scale change in health care systems have evidence-based improvement methodologies (such as Lean CQI) as a core component (59).
ISO (International Organization for Standardization) is the world’s largest developer of standards. Since 2000, the worldwide standard for a quality system in business and industry has been the ISO 9001 guidelines (the fourth edition is published by the ISO). Countries trading products across international boundaries have found the standardized requirements very beneficial in improving quality; this approach has also reduced the time and cost of multiple inspections due to the international nature of their business. In the future, there will be a universal standard for quality management in medical laboratories: ISO 15189 (60, 61). ISO 9001 Quality Management Systems is under review and an updated version is expected by the end of 2015. All ISO standards are reviewed every 5 years to make sure they remain as helpful and relevant (http://www.iso.org, accessed 4/3/2015).
When the large majority of products or services in a particular business or industry sector conform to International Standards, a state of industry-wide standardization can be said to exist. This standardization is achieved through consensus agreements between national delegations representing all the economic stakeholders concerned: suppliers, users, government regulators, and other interest groups, such as consumers. They agree on specifications and criteria to be applied consistently in the classification of materials, in the manufacture and supply of products, in testing and analysis, in terminology, and in the provision of services.
According to their objectives, laboratories will choose a recognition of their quality management system with an ISO 9001 certification or a recognition extended to the technical skills with an ISO 17025 or ISO 15189 accreditation. The contents of these last two documents are very similar, and both integrate requirements of the standard ISO 9001. The standard ISO 17025 is somewhat distant from clinical laboratory needs, requiring many efforts of adaptation, just like the ISO 9001 standard. The standard ISO 15189 seems to be well adapted but more constraining, considering the detailed requirements required. It necessitates a perfect control of the preanalytical phase, which is difficult to acquire in a clinical framework where the clinical specimens are not taken by the laboratory staff.
A number of advantages are associated with the use of ISO. The focus on patients has been reestablished, all processes are identified and subject to continuous improvement, and performance measurements provide an integrated picture of results. Measurements subsequently lead to improvement of quality of care and to quality system improvements. The documentation system can serve the organization’s needs without leading to bureaucracy. Given the need for adequate quality management tools in health care and the need to demonstrate quality, the positive effects suggest that ISO will become more prevalent in health care organizations (62).
ISO provides technical and quality management, which results in benefits observed in daily laboratory practices. Technical requirements can include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program. Also, an expanded definition of the sample preparation process can be implemented and documented to maintain consistency in sampling. Management quality improvements often emphasize document control to maintain consistent analytical processes, improved monitoring of supplier performance, a periodic contract review process for documenting customer requirements, and a system for handling customer comments and complaints. Continuous improvement is monitored and improved through corrective and preventive action procedures and audits. Quarterly management review of corrective actions, nonconforming testing, and proficiency testing results also identifies more long-term trends. The practical benefits of these technical and management quality improvements can be seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, and overall increased laboratory business are all the result of implementing an effective quality system. Certainly, the ISO system provides one option among various quality improvement approaches (63).
In the 1990s, blood centers and transfusion services within the United States began adopting the concepts of quality systems into their routine operations, primarily based on direction provided by a 1993 FDAQA guideline (64). After a series of revisions, the American Association of Blood Banks (AABB) published its 10 Quality System Essentials (QSEs) (65). These have been incorporated into the most recent edition of the AABB Standards for Blood Banks and Transfusion Services (66).
It became very obvious that the QSEs proposed for the blood bank were applicable to the entire laboratory operation. These essentials also incorporated many of the quality requirements developed by CLIA ’88, The Joint Commission (formerly JCAHO), and the College of American Pathologists (CAP).
Recognizing that standardization would be not only valuable, but also essential for high-quality laboratory operations as a whole, the Clinical and Laboratory Standards Institute (CLSI) (formerly known as the National Committee for Clinical Laboratory Standards [NCCLS]) developed a subcommittee to prepare a guideline encompassing a complete quality system for the clinical laboratory. This