Governance, risk, and quality management in the medical laboratory

Background

Quality management (QM) is a set of principles for coordinating management and improvement activities to ensure that an organization continuously meets the requirements of its customers (users), even as those needs change. There are many approaches to and tools for deploying these principles, some tools focusing only on selected principles. It is widely regarded as best management practice when these principles are fully adopted as an organizational framework.

Quality management systems (QMS) are consensus-driven structured frameworks for ensuring consistency in the quality of products and services to meet customer needs. Both QM and QMS evolved from technical quality, namely, quality control (QC) and external quality assessment/proficiency testing (EQA/PT) activities, and these elements still play important roles. The International Organization for Standardization (ISO) has developed ISO 15189 as an internationally accepted QMS standard suitable for accreditation of medical laboratories. In some countries, alternative or additional standards or accreditation requirements may apply.

Further evolution and development of this framework is continuing. Laboratory medicine is different to many other industries because it includes the patient, and thus carries additional ethical and legal responsibilities for maintaining patient safety and optimizing and improving patient care—this is addressed under the banner of clinical governance. There is also increasing recognition of the need to prioritize and focus efforts on those organizational activities most vulnerable to failure or with the greatest consequences—this is addressed through risk management. And layered on top of these frameworks and standards is the recognition that leadership and accountability are required to drive and maintain quality improvement.

Content

The most widely adopted QMS used internationally (ISO 15189) is described in some detail and is compared with an alternative or supplementary framework (Clinical and Laboratory Standards Institute [CLSI] QMS01). The role of standards and guidelines in self-assessment and in the accreditation and regulation of medical laboratories, and the differences between accreditation and certification are explained. The principles of clinical governance and risk management are described and their links to QMS are explored. Finally, the philosophy and principles of QM are described, and within this, the rationale is explained for a QMS as a means of maintaining and controlling existing operations, as well as systematically improving the quality of test results and organizational services. Various pathways taken by laboratories to implementing QM are considered, and various structured quality improvement tools and management approaches are described.

Purpose and scope of a medical laboratory

The services of a medical laboratory play a key role in the practice of modern medicine. In different countries, and indeed within individual countries, there are different views of what constitutes the scope of a medical laboratory service and its purpose. International Organization for Standardization (ISO) 15189 is the international standard for quality and competence in the medical laboratory.

ISO 15189 defines a medical laboratory as a “laboratory for the ... examination of materials derived from the human body for the purpose of providing information for the diagnosis, management, prevention, and treatment of disease in, or assessment of the health of, human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigation.” The standard itself details a specific requirement for advisory services that includes the provision “of advice on the choice of examinations and use of services including repeat frequency and required type of sample” and “where appropriate, interpretation of the results of examinations.”

Note that the definition also states: “Facilities which only collect or prepare samples, or act as a mailing or distribution center, are not considered to be medical or clinical laboratories, although they may be part of a larger laboratory or system.”

Defining quality in the medical laboratory

Discussions of quality in relation to the medical laboratory often invoke phrases such as “fit for purpose” or, in the case of a laboratory test or examination, as being “fit for its intended use.” The importance of these phrases is that they link the quality requirement to its purpose.

The ISO definitions of quality have evolved over a number of years with ISO 9000 defining quality as the “degree to which a set of inherent characteristics fulfills requirements,” where requirement is a “need that is either stated, generally implied or obligatory.” The bias and imprecision of a measurement process are examples of inherent characteristics (i.e., inbuilt features, as distinct from, say, the price charged for a particular test, which is an assigned characteristic).

Quality, as defined, is judged by the ability to reliably meet needs and expectations. This concept of quality as not being an absolute, but rather being matched to specific needs, has important implications. For example, a patient with suspected hypoglycemia would have a different requirement for the timeliness of a blood glucose result compared with an asymptomatic person being screened for diabetes. A test might have inherent characteristics that meet appropriate analytical and biological goals and yet still not be fit for purpose because it was not delivered in a timely manner and thus failed to fulfill the stated requirements.

In later chapters, statistical techniques are described for ensuring that analytical processes remain in control (see Chapter 6 ) and for ensuring that analytical results meet biological requirements (see Chapter 8 ).

It should also be noted that, with rapid change in all of medical practice, scientific advancement, and in broader society, even after optimization to ensure that all laboratory services are of appropriate quality, changing circumstances require ongoing and constant monitoring and adjustment of laboratory performance to ensure that it remains correctly matched to the needs of patients, users, and customers. That is, a systematic continuous improvement process is essential.

Evolution of the approach to quality management

Quality management (QM) had its origins in the 1930s with Shewhart’s work on the understanding and control of analytical variation. This changed the quality process from “inspect for errors after production” to “control the process to reduce the errors produced,” which became the classic quality control (QC) approach and is these days formalized in statistical process control (SPC) (see Chapter 6 ). Shewhart also introduced a cyclic method for making improvements, which has become known as “Plan-Do-Check-Act” (PDCA cycle). This was important because it introduced a systematic approach to improvement, which has since spawned a vast array of improvement methodologies, including the very successful “Define, Measure, Analyze, Improve, Control” (DMAIC) methodology of Six Sigma.

Within the field of laboratory medicine two key themes have driven major improvement: firstly, the introduction of EQA/PT programs, a form of benchmarking, highlighted great variability in laboratory performance first in technical quality and later service quality; and secondly, the introduction of QMS brought a systematic approach to managing, giving greater control to enable improvements to be made and retained in place.

There has always been parallel development of different approaches to the broader management of quality, including governance and risk management outside healthcare. Laboratory medicine has adapted those techniques that work in healthcare. The result is that quality can be seen from several viewpoints, each providing valuable tools for managing laboratory quality.

Although some laboratories see their role as primarily the delivery of analytically correct test results, this is a very narrow view and one that overlooks the reality that an analytically correct result may still be of poor quality because of not meeting, for example, turnaround time, cost, result delivery method, or any of a host of user-specified criteria or expectations. A quality laboratory service is one that knows at all times the users’ criteria and needs and has internal systems that can ensure these are met. Whenever user requirements change, a quality laboratory will have procedures to detect these changes, even if unannounced, and will adapt itself to respond appropriately.

To have the organizational sophistication to be able to achieve these degrees of responsiveness may take time. Although some laboratories see “meeting accreditation standards” as an end in itself, such laboratories will lose the benefit of the culture of organization-wide customer focus and systematic continuous improvement that comes from the use of a QMS to drive overall quality, rather than being merely a tool for achieving the minimum acceptable standard. Laboratory organizations typically evolve or mature through various stages in their understanding and adoption of QMS, and this rate of maturity is generally driven by management leadership. Governments may seek to accelerate this process by mandating that some of these stages are a condition of operation.

The rest of this chapter is presented as four main topics:

• Governance (including clinical governance), benchmarking, and risk management,

• QMS, including internationally applicable standards and guidelines and the key components of such systems

• Accreditation and regulation of medical laboratories, including an international model that includes self-assessment through accreditation and regulation

• Approaches to QM, integrating its basic principles

Governance

Historically, governance, risk management, and compliance are three related facets that aim to assure an organization reliably achieves its objectives, addresses uncertainty, and acts with integrity. Regulatory compliance means conforming with stated requirements. At an organizational level, it is achieved through management processes which identify the applicable requirements (defined, e.g., in laws, regulations, contracts, strategies, and policies) including ethical and prudential expectations, assess the state of compliance, assess the risks and potential costs of noncompliance against the projected expenses to achieve compliance, and hence prioritize, fund, and initiate any corrective actions deemed necessary or appropriate.

Governance and management of risk and compliance are not new, and most organizations including laboratories have been governed and their risk and compliance managed in the past, but an understanding of the interlinked nature of these activities is more recent.

Healthcare organizations, both public and private, have traditionally been controlled by boards or equivalent structures, as corporate entities with a focus on the strategic direction of the organization as a whole and ensuring that the operations, finances, and risk management systems are in place to meet statutory and prudential requirements. It has become apparent that errors and omissions probably occur more frequently in healthcare than in other industries or fields of activity, and certainly at a higher rate than is acceptable to the public ; from these findings has emerged acceptance there is a need to have more accountability for clinical care delivery. The term governance describes the overall management approach through which senior executives direct and control the entire organization, using a combination of management information and hierarchical management control structures.

In healthcare settings, (clinical) governance of healthcare or more broadly, governance of clinical effectiveness and clinical performance, has become increasingly important. The approach to this challenge has been the integration of QM and risk management under an umbrella of clinical governance.

The term “clinical governance” emerged in health during the 1990s and is used to describe the framework through which health organizations are accountable for continuously improving the quality of their services and safeguarding high standards of care. It is an extension of self-regulation that acknowledges the complexities of the delivery of modern healthcare in an integrated, organization-wide context and has been defined as “a framework through which ... organizations are accountable for continuing to improve the quality of the service and safeguarding high standards of care by creating an environment in which excellence in clinical care would flourish.” Clinical governance can be viewed as a whole system of cultural change that provides the means of developing the organizational capability to deliver sustainable, accountable, patient-focused, and quality-assured healthcare. The main components of clinical governance are described in Table 3.1 .

Quality initiatives to facilitate clinical governance in the laboratory include accreditation to an external standard such as ISO 15189, and benchmarking.

Benchmarking

Benchmarking is the process of measuring products, services, and practices against peers and leaders in a field, allowing the identification of best practices that might lead to sustained and improved performance. Performance can be compared either in a generic way, in which there is a comparison of a process regardless of the industry, or in a functional way, in which there are comparisons within the same industry. Laboratories seek to benchmark for four main reasons: quality improvement, for accreditation requirements, to meet funder requirements, and to improve competitive advantage.

It has been shown that laboratories that regularly report on a particular aspect of quality tend to perform better on that quality measure than facilities in which this regular monitoring is not taking place and that benchmarking quality over time is also associated with improved performance.

There are a number of benchmarking schemes available to clinical laboratories including The Benchmarking Partnership (UK) and the College of American Pathologists’ (CAP) Q-Probes scheme. Variation in clinical practice between laboratories may be identified through benchmarking and this may lead to an agreement over what should be best or preferred practice.

Risk management

Risk management is defined by the European Foundation for Quality Management as: “The systematic use of organization-wide processes to identify, assess, manage, and monitor risks—such that aggregated information can be used to protect, release, and create value.” Risk includes not only clinical risk but financial risk, facilities, workplace health and safety, and reputational risk. There are three types of risks: predictable risks that organizations know they face; the risks which an organization knows it might run but which are caused by chance; and the risks that organizations do not know they are running. The response to risks typically depends on their perceived gravity and involves controlling, avoiding, accepting, or transferring them to a third party.

The ISO standard that describes risk management is ISO 31000:2018, Risk management—Guidelines, which provides principles, framework, and a process for managing risk. The following diagram ( Fig. 3.1 ) is modified from this standard and describes the risk management process and the interconnections with monitoring and review, which are related to QM, and communication and consultation which is a component of governance.

Using this approach as our model we will start with the contextualization of risk in a pathology laboratory. The context refers to the question of what is at risk, and the potential sources of risk associated with the preanalytical, analytical, and postanalyticall processes, but should also consider risks associated with operations, such as billing, human resources, security, privacy, and safety.