Building on existing models, distinct phases of laboratory quality were identified and organized into phases comprising the Lab Quality Continuum (LQC), a tool designed to help laboratories determine their current level of quality. A self-assessment was developed to accommodate this function and to provide improvement recommendations.
The objective of this study was to assess the current state of clinical laboratory quality in clinical laboratories via the LQC Self-Assessment.
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Making An Evidence Based Financial Case for Investment in Lab Quality Quality with COPQ
Far too often, cost reduction within the lab results in funds being allocated away from the quality department and its initiatives. This department (or quality function if not centralized) is especially vulnerable to cost cutting because quality activities are often not directly involved in the laboratory workflow. Because quality departments are not revenue generating, they are often seen as cost centers. Therefore, they are sometimes seen as a “nice to have.” As resources become scarce, some labs struggle to justify this investment. The COPQ concept can help illuminate the widespread financial impact of nonconforming events as well as the value of investing in quality initiatives. With proof of a positive return on investment (ROI) in the form of cost savings and/or cost avoidance, lab leaders are empowered to present a compelling argument for quality initiatives to the C-suite.
As I work to spread awareness within the clinical laboratory community about the Cost of Poor Quality (COPQ) concept and its benefits as a method to demonstrate a financial return on investment (ROI) for quality-related efforts, I have often encountered pushback that a portion of the COPQ is cost avoidance and therefore cannot be seriously considered as part of the return on investment. While I agree with that argument in that cost avoidance does not directly impact profit and loss statements for the laboratory, I do think that cost avoidance is an important factor to consider when determining the benefit of a quality initiative or program.
This article aids lab leaders in differentiating between cost savings or cost avoidance for a given initiative or in successfully eliminating a root cause for a specific event. This simple example effectively illustrates the differences, helps to solidify the concepts and will allow you to articulate the real, but often underappreciated, benefit of cost avoidance.
The CoPQ concept can be useful in demonstrating the financial value provided to a clinical laboratory or hospital by its quality program through the cost avoidance and cost savings realized by eliminating root causes of nonconforming events. Without the interventions enabled by the nonconforming event management system and lab quality program improvement initiatives, the laboratory and/or hospital would continue to experience financial losses for these opportunities, in addition to potential patient safety risks. Further, calculating CoPQ aids laboratory leadership in identifying the often large amount of waste in everyday operations, more effectively triaging nonconforming events for remediation, and in justifying additional investment in quality tools and resources. This article provides useful recommendations to help you implement a CoPQ program in your lab.
Laboratories are constantly seeking to improve their services for the benefit of their patients, but are usually under significant budgetary constraints. Sometimes all that is required to improve patient safety is a little creativity and ingenuity. This article describes a real life case study, with the details changed, highlighting the innovative minds of medical laboratory scientists and their counterparts on the patient-centered care team. This case study highlights the fact that not all quality improvement projects require substantial financial investment or a sophisticated solution. Oftentimes in the laboratory and in healthcare as a whole, we are limited financially. I have encountered countless examples of simple, effective solutions to quality issues in the laboratory. I am constantly impressed by the creativity and resourcefulness of medical laboratory scientists and other healthcare practitioners.
Quality is a nebulous word. Undoubtedly everyone who works in the clinical laboratory agrees that quality is important, but what exactly does the word mean? How is quality defined, how is it measured, and what does the quality function entail? Complicating matters, the word is commonly conjoined in terms such as quality control, quality assurance, quality improvement, and quality management, which all too often are used interchangeably. This haze around what constitutes quality in the lab often leads to confusion about the quality role. Therefore, it is important to clearly define the role of the quality function in the clinical laboratory (often referred to as the Quality Assurance [QA] or Quality Management [QM] department) and to help laboratory leaders optimize this important function. This article presents tried-and-true tips to ensure the success of your lab's quality program.
Production demands often trump quality initiatives in the lab. Lack of involvement and investment in lab quality programs can negatively affect patient safety, accreditation and regulatory status, reimbursement, and workplace culture, as well as introduce legal risks and costs to the laboratory.
Learn about Cost of Poor Quality (CoPQ) and how you can use this concept as a tool to improve your bottom line through investment in quality. Contact us for an Excel based tool to help you calculate CoPQ and for consultations on how you can get started tracking CoPQ in your lab!
ISO 15189 is the international gold standard for quality in the clinical lab. Many labs are pursuing voluntary accreditation or incorporating ISO 15189 into their quality programs. As this standard is relatively new, many lab leaders struggle with where to start.
Increased patient safety, reduction in cost of poor quality (CoPQ), fewer malpractice claims, preparedness for changing reimbursement, regulatory compliance, and differentiation in the marketplace are just a few of the numerous benefits that a comprehensive quality program can afford a clinical laboratory. Establishing a quality management system (QMS) for an existing lab that has never had a quality department or the necessary infrastructure may feel impossible. However, if your laboratory is ready to develop a quality program in order to reap the many long-term benefits, you can do a few key things to increase your chances of success.
Lean and Six Sigma typically focus on eliminating waste, reducing variation and improving processes performed to make the service or product itself. Quality Management Systems are more holistic and focus on ensuring that policies, processes and procedures are in place to achieve the organization’s quality goals to meet customer expectations, regulatory requirements and to achieve business excellence. Lean and Six Sigma are continuous improvement tools that can be considered a subset of a QMS. A Quality Management System, whether adopted from a standard or guideline or completely home grown, however, is imperative to a laboratory’s success.
If you run a Google search for the terms “quality assurance” and” quality control”, I am 99% certain your search will return a number of differing definitions. “Quality management”, “Total quality management” and “Quality improvement” are additional terms that are used frequently, adding to the confusion. Many of these terms are often used interchangeably. You may think these terms are more alike than different as they all contain the word “quality”, but they are not synonymous.
Let’s explore some definitions to make sense of this alphabet soup.
How honesty and transparency can help your lab climb the quality hierarchy