Quality Management in a pathology laboratory setting
The terminology and the philosophy used to determine what quality is has changed, rather significantly over time. Today, the prevailing approach to quality management is the need to establish a broad and all-encompassing system that ensures the users will receive a quality service or product consistently. Moreover, quality is understood as a process that must be continuously improved, while the knowledge gained in the process of improvement must be used to facilitate future changes and improvements. The International Standard ISO 9000 defines quality as the degree that a set of features fulfils the need or expectations of the user. For a biomedical science laboratory this means that a user should receive the right result for the right person in the right time frame. In a laboratory environment the user is generally the requesting clinician, but could also be a nurse, medical secretary, fellow biomedical scientist or, indirectly patients themselves (Beastall, 2008; Kelly, 2007; Burnett, 2013).
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Effectively, quality is a cyclic process that cannot reach fruition but can bear an ever-improving set of outcomes, depending on the setting and industry. The demand for articulate and legitimate results is especially high in science, technology, medicine, and the role of laboratory analyses has become paramount. Some estimates suggest that laboratory-based research and processes take up around 5% of the gross domestic product in more developed economies (Nevalainen et al., 2000; Van Kriekenet al., 2013).
The pathway towards quality management was very similar for pathology laboratories and general industry. In the 1990s, for example, quality management was an almost unknown term. Each laboratory had a set of procedures that were unique and there was no overarching set of standards that would inform practice. Moreover, much of the work done in pathology laboratories was considered to be outside of the domain of the “hard” sciences and in the sphere of more descriptive disciplines (Nevalainen et al., 2000; Van Kriekenet al., 2013).
General determinants and definitions of quality management
The domain of quality management in laboratories started to emerge roughly at the same time it became apparent that laboratory work needed to be assessed to show competence of the laboratory. For the most part, pathology is a specific branch of medicine that requires significant focus on analytical thinking, proper procedure and monitoring of results. Even the slightest omission or mistake in the laboratory report will give a false positive, or a false negative, which can have significant impact on the outcome of future treatments, can jeopardize livelihoods (for example a wrong negative may provide evidence for a malpractice suit), and generally jeopardize the wellbeing of patients (Libeer &Ehrmeyer, 2004; VikashGaur & Raghav, 2016).
The process of quality management can be presented as a set of tools and benchmarks that serve to determine whether the current processes and functions within a company, laboratory, or any other institution that delivers services or products to clients. Quality is generally managed through the adoption of one of the international recognized standards. These bring together the different dimensions of control – system development, management, and quality. To understand this, it is necessary to understand that quality emerges from standards (Weinstein, 1995; Burnett et al., 2002).
This means that those organizations which have well developed systems and management processes tend to perform better, make fewer mistakes, and are generally more robust. In the context of healthcare this is of immense importance because of the specific nature of the sector. A biomedical scientist operating outside of the prescribed system cannot be sure that the results provided are accurate and precise. If, however, said biomedical scientist operates within the confines of a QMS, then the results are more likely to be viable simply because the processes used in obtaining them have been codified, examined and approved within the QMS. For example, testing blood in a laboratory requires a set of procedures to be conducted. Each of these procedures can provide false results if the machines used are not properly calibrated and controls not performed, if the technician is not trained and competency assessed in the method and there is no standard operating procedure in place. This demonstrates that quality plays a large role in the job of all members of staff (Ovretveit, 2000; Guzel & Guner, 2009).
In most cases, laboratories must adopt the ISO 15189:2012 system of quality management. What this does is essentially provide the laboratory with a set of guidelines for procedures that have been recognized internationally and accompanied by the appropriate documentation. Moreover, ISO 15189 and other QMS certifications allow laboratories to develop their own processes and have them certified (for example if the laboratory is conducting research that is not common, or proprietary, or uses technology not available to other laboratories). In addition, laboratories use the ISO 15189 accreditation system to ensure the end-users that the laboratory conducts its tests according to internationally accepted norms (Guzel & Guner, 2009; Hacham et al., 2007).
In more general terms, quality management comprises several domains such as staff education and conduct, equipment, GLP (good laboratory practices), standardization of processes, validation, reference materials, and others. Education of the staff and continued professional development is critical, especially in the domain of professional responsibility and skills related to their assigned tasks. Equipment is a key element of QMS because lack of maintenance or control can lead to false results (Beastall, 2008; Kelly, 2007).
One of the main goals of a quality management system is to ensure that a user’s needs are always met, and their expectations exceeded. This is achieved through various tools such as departmental quality meetings, audits, risk assessments, key performance indicators (KPI), corrective actions/preventative actions and raising change requests. These tools can be managed using quality management system software such as Qpulse. In the medical laboratory quality management meetings are generally conducted once per month. During these meetings each of the required elements of the Management Review are discussed, these include:
- Reports from managerial and supervisory personnel.
- Assessment of user satisfaction and complaints.
- Internal audit of quality management system.
- Internal audit of examination processes
- External quality assessment reports
- Reports of assessments by outside bodies.
- Status of preventive, corrective and improvement actions
- Quality indicators.
- Major changes in organisation and management, resource (including staffing) or process.
- Follow up of previous management review.
- Review of Quality Manual & Policy.
- Review & setting of quality objectives.
Records of these meetings are kept, and key objectives defined, plans are then drawn for implementation which forms the review output. As user feedback is so essential, it is imperative laboratories ensure they listen to the user requirements. This can be done by having a complaints procedure in place and offering user surveys to monitor customers satisfaction (Burnett, 2013; Oakland, 2014).
A system of Internal Audit is essential for a good QMS, it allows for the examination of pre-analytical, analytical and post analytical practices in place across all departments. A calendar of planned and scheduled audits, conducted against agreed criteria, is carried out by audit trained staff ideally independent of the section to be audited. Audits should also be added to the calendar when an adverse incident or introduction of new methods occur. Any non-conformances identified through audits are investigated. Non-conformances can also be raised by any service users. Once a non-conformance is identified and raised an investigation should be carried out to determine the root cause and appropriate corrective action to stop the non-conformance occurring again. Part of the corrective action should include a monitoring process that shows the corrective action is effective. If the monitoring demonstrates a re-occurrence of the same non-conformance, additional corrective actions should take place. Preventive actions can be identified in several ways, including the reviewing of external quality assurance and environmental monitoring as well as through the audit process. Preventive actions are reviewed at departmental Quality Meetings (Burnett, 2013; Oakland, 2014).
Key performance indicators (KPI) should provide the laboratory with achievable and realistic targets with the aim of improving the service for the users, these are discussed during the quality meetings to monitor progress (Burnett, 2013).
To manage risks a mechanism should be in place that can identify and reduce risk factors including:
- End to end risk assessments of processes
- Risk Assessments of individual tasks, both from the analytical and health and safety aspects
- Incident reporting and management
- Production and review of a risk register.
A risk register can be used to capture health and safety risks and process-based risks which may affect patient safety or the quality of the service (Burnett, 2013).
Calibration and the maintenance schedule must be clear and well developed in order to ensure their proper function. GLP is a group title for a set of processes and practices within the laboratory that pertain to all elements of practice, from material handling, reporting, marking, warehousing, to disposal of waste. In short, GLP is focused on the immediate quality of the materials and processes used in the laboratory (Kenny, 2001; Libeer & Ehrmeyer, 2004).
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Standardized procedures are essential for laboratory practice as they ensure that all individual tests give out valid results. In general, each laboratory develops these individually, but some are determined by international bodies. Validation is the documented process of determining the validity of the measurement system within the laboratory. Without it, it would be impossible to know whether the results are accurate (Kenny, 2001; Libeer & Ehrmeyer, 2004).
Pathology and quality management
The question of quality management in a pathology laboratory is not simply the decision to improve quality or work processes. Rather, it can be the decision between positive and negative treatment outcomes for patients. Because nearly 70% of all decisions in immediate clinical practice depend on the results obtained through laboratory testing, it is clear that quality management represents a critical issue. Moreover, it could be argued that quality represents the key challenge for all laboratories and especially those within the healthcare system. The ability to verify and ensure the validity of test results is directly related to the wellbeing of the patient, which explains the onus on quality. Therefore, quality management in a pathology laboratory must be understood as a complete system of control designed to ensure the validity of its results (Plebani et al., 2015; Hacham et al., 2007).
An important aspect of quality management in a pathology laboratory is the quality appraisal. This is the process of comparison, measurement and grading the level of performance in laboratories without a specified set of standards and internationally recognized norms. There are two forms of testing normally utilized in laboratories, internal and external. Internal quality control is a set of procedures conducted by the staff in order to assess the quality of the results produced by the laboratory (Guzel & Guner, 2009; Hacham et al., 2007).
It is conducted continuously and includes blind tests, measurement standards, surrogate samples, repeat measurements, independent measurements, CRM, control charts, and others. Each of these was designed specifically to verify the results and ensure repeatability. This is the process with which each procedure and analysis conducted by the laboratory can be replicated using the same sample and the same procedure and will yield in the same results. (Plebani et al., 2015; Hacham et al., 2007).
External quality assurance is based on testing of the proficiency of the laboratory itself. This pertains to the examination of the ability of the laboratory and its staff to conduct specific tests using intra-laboratory comparison tests (nHRN). This type of testing is conducted by the reference laboratory or the assigned institution where groups of laboratories are analysed for a specific segment of their processes using a stable sample. If all laboratories yield the same results, it shows their processes are valid (Plebani et al., 2015; Kenny, 2001).
Systems of quality
The two most commonly used quality management systems are ISO 9001 and ISO 15189. One of the pitfalls of these models, and ISO 9001 specifically was the fact that it was a broad system of quality management that was meant to be multipurpose tool for a large number of industries. However, laboratory quality control necessitates a much more analytical approach, and one that is focused on quality across all subsections of the internal processes. To this end, ISO 15189 represents a much better option, since it is targeted specifically for use in a laboratory setting (Aoyagi, 2004; Hachim et al., 2007).
Even though ISO 9001 was not developed for laboratories specifically, it was widely used because of its ability to ensure consistency and quality of processes, something that was sorely lacking in healthcare. Moreover, the use of ISO 9001 allowed quality management to be implemented on a global scale using standardized systems and measures. This was, at the time of implementation an unprecedented leap forward. The development of ISO 15189 designed specifically for medical laboratories was a step forward, as it allowed specific elements of laboratory practice to be standardized and measurements developed that would further enhance the quality of the procedures and the overall success rates of individual laboratories. These advances allowed a much more reliable and industry related measurements and finally better care delivery (Buchta et al., 2018; Thompson & Wood, 1995).
As Nevalainen et al (2000) argue, even after the implementation of quality management systems in laboratories, there exists a strong incentive to continue the improvement, primarily because it was found that laboratories can still yield false results, even if this has been reduced substantially. The use of ISO standards in laboratory practice, then, have had a demonstrably positive effect on the overall performance of laboratories.
The use of QMS in laboratories has been one of the main turning points in terms of quality of analysis and results provided by pathology laboratories. The implementation of ISO norms, first 9001 and then 15189 allowed for a more standardized approach to testing, equipment manufacturing, sampling and process development than it was possible before. All the advancements made have had a significant impact on the overall structure, performance and development of pathology laboratory. Keeping in mind that nearly 70% of all clinical decisions are based on the results obtained from pathology laboratories, it becomes apparent just how big of a difference QMS makes in this segment.
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