Jessenia Cornejo, will be speaking at HCCA Hawaii Regional Healthcare Compliance Conference on October 7, 2021.
Jessenia Cornejo, Senior Consultant of Compliance and Quality, will be speaking at HCCA Hawaii Regional Healthcare Compliance Conference on October 7, 2021. The conference is available for online attendance.
The title of the talk:
Maximizing Your Audit & Monitoring Program
Find out more at the HCCA website.
Lab Insights Founder, Robert Young, is a confirmed speaker at the 11th annual Next Generation Dx Summit. He will be leading a short course titled Data-Driven Process Development in the Clinical Laboratory. The conference will take place in Washington D.C. from August 20-22 2019. The course is scheduled for the 21st at 6:45 pm.
Lab Insights Founder, Robert Young, is a confirmed speaker at the 11th annual Next Generation Dx Summit. He will be leading a short course titled Data-Driven Process Development in the Clinical Laboratory. The conference will take place in Washington D.C. from August 20-22 2019. The course is scheduled for the 21st at 6:45 pm.
The modern clinical laboratory utilizes complex, data-rich computer systems. In this course, you will learn how to leverage your laboratory information systems to build data-driven processes, create data-driven process improvements, and make data-driven business decisions.
Short course tagline
The course is intended for laboratory and health IT professionals who want to learn more about how to build data-centric processes and electronic systems in the age of machine learning. To find out more about the conference, click here.
The modern clinical laboratory utilizes complex, data-rich computer systems. In this course, you will learn how to leverage your laboratory information systems to build data-driven processes, create data-driven process improvements, and make data-driven business decisions.Key topics that were covered:
Below are notes previously reserved for customers that we are making available to all
First and foremost, understand and document your requirements.
Open source software is not widely used in the U.S. in the clinical laboratory setting. This is unfortunate, because the benefits and values of open source greatly outweigh any drawbacks in many cases. Here, we will briefly describe 5 top reasons your laboratory should consider open source software.
Most open source software is complete free of charge, which is a great benefit to small companies concerned about their bottom line. Many companies, including Lab Insights, LLC, offer paid support for their free software. This can ensure that your lab gets a quality product with support and customer service that they expect. Proprietary vendors, like Microsoft have argued in the past that the total cost of ownership for free software is higher than their paid solutions, but we believe that this in an antiquated belief. This is evidenced the emergence of many successful open source companies, like Canonical and Red Hat, and many other successful companies that rely on open source software for their business, such as Facebook and Google.
With open source software, you can count on the fact that the software you use will be around for years to come. Good open source software is built to last, and is not subject to the whims of a company that may make breaking changes to their product while requiring you to upgrade. There is no license key that will expire on you just when you need it most. You’re software will just continue to work.
Since the code is available, and version control is generally done in the public, Savy open source software consumers can audit the code, or pay to have it audited by professionals. This means that you can be confident in the security and functionality that is promised by the software developers. You can also check for unwanted features, such as security backdoors and private data siphoning. Open source software can be trusted because you can look for yourself.
Richard Stallman, one of the pioneers of the free software movement, is attributed to developing the four essential freedoms of software. In a nutshell, they state that users should be free to run, examine, distribute, and modify software as they see fit. In a laboratory setting, this can be extended to the data that is generated by the software. When it comes to free and open source software, your date is your data.
Open source also means open interfaces. All of the popular open source tools have documented interfaces, and are designed for interoperability. Since you are free to modify the code, open source software can be extended for even more interoperability as your needs change.
While there are many advantages of using open source software in your laboratory, it does come with some risks and challenges. Most noticeably, technical support for many open source projects is either not available or hard to come by. While in many cases this is not an issue, having professional support can be a key part of IT strategy. Be careful to choose software that not only meets your functional requirements, but also your IT support needs as well. For more information regarding some of the challenges, read this article.
On Friday, November 18th, the Food and Drug Administration (FDA) announced that it would not seek to finalize its guidance on laboratory developed tests (LDTs) prior to the Trump Administration taking office. Since then, the agency has elaborated on some of the details of this announcement, claiming:
While excessive oversight can discourage innovation, inadequate and inconsistent oversight in which different test developers are treated differently can also discourage innovation by making it difficult for high-quality test developers to compete with poorer performing counterparts.
Can you put a price-tag on developing, deploying, and maintaining high-quality computer systems in your organization? How about estimating the cost of poor-quality of your systems? In this post, we will explore the cost of quality of Laboratory Information Management Systems and related software for scientific data management.
Quality costs have been studied since at least the 1950s. Before it was first formally characterized, people in business anecdotally understood that higher quality products and services meant higher costs, but also had the potential to lead to better sales and higher profits. Naturally, trade-offs must be made to ensure that an organization can control costs while being able to deliver products and services that meet the demands of their customers. The problem was there were no concrete ways to measure the cost differences between good and poor quality. Academics and accountants soon began developing models for measuring these costs based on empirical evidence from different industries.
Cost of Quality accounting has been proven to be a useful practice in measuring the effectiveness of quality management systems for the manufacturing industry, and has adapted and modeled for Software development as well. However, it has not been widely incorporated into most Software Quality Assurance groups in the informatics industry. In this article, we will explore some of the common sources of quality costs in software and how proactive measures can be taken to reduce them.
When examining Quality Costs, there are two general categories:
Conformance Costs, sometimes referred to as Achievement Costs or the Costs of Good Quality, are costs associated with maintaining good quality. Conformance Costs can be further categorized into appraisal and prevention costs. Appraisal costs are the costs associated with measuring, evaluating or auditing products or services to assure conformance to quality standards and performance requirements. Prevention costs are the costs of all activities specifically designed to prevent poor quality in products and services.
The table below shows examples of common appraisal and prevention costs in software quality.
| Prevention Costs | Appraisal Costs |
|---|---|
| Project Management | Unit Testing |
| Requirements Management | Integration Testing |
| Continuous Integration | External Audits |
| Functional Testing | Quality Assurance |
Non-conformance costs, sometimes described as the costs of poor quality, are costs associated with remediating the affects of poor quality. These costs have two general sources:
The table below shows examples of internal and external failure costs.
| Internal Failure Costs | External Failure Costs |
|---|---|
| Design Change Rework | Customer Support |
| Defect Management | Warranty Rework/Repayment |
| Retesting | Reputation Management |
| Requirements rework | Market Loss |
Examples of internal and external costs of failure are obvious for any software development organization or department, but determining the best way to measure these non-conformance cost is not as apparent. Also, even if the costs can be meaningfully quantified, the more challenging problem is determining how to balance conformance costs with non-conformance costs. Anecdotal evidence tells us that it is usually easier to justify non-conformance costs to senior management, especially in young companies. It is human nature to not consider how to avoid an issue until after it has already affected you, and no business person wants to spend money on items that does not add value to the business.
It is the responsibility of the quality department in these organizations to clearly and effectively communicate the value of good quality, and how it is cheaper in the long run than bad quality.
Developing a quality cost program is the best way to account for all costs of quality, and the best way to show the value of good quality to the organization. For the program to be effective, it is important to choose the most appropriate metrics to gather, and to present the results to senior management and other stakeholders in a thoughtful and engaging way.
If your organization manages quality software, consider how the costs of quality are accounted and managed.
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