Next Generation Dx Summit Short Course Scheduled

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.

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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.

Robert Young gives short course at Bio IT World – West

molecular Tri-Con Quote
Molecular Tri-Con Quote
On Sunday March 10, 2019, Robert Young, Founder and principal consultant for Lab Insights, LLC, presented a short course on Data-Driven Process Development in the Clinical Laboratory.

Course topic

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:
  • Identification of process performance indicators
  • Exploration the intersection of quality improvement and business improvement
  • Cultivating a data-first culture in your organization
  • Examination of a vendor-agnostic approach to laboratory computer system implementation and design
See the details of the course here. More topics and conference talks to come.

How to Choose a Health IT Vendor

Below are notes previously reserved for customers that we are making available to all

Vendor selection basics for the informed customer


First and foremost, understand and document your requirements.

  • Compare each vendor’s features to your requirements
  • Grade how each vendor meets each requirement
  • If a requirement is not addressed in the demo, ask a question

Key IT Requirements

  • Your data is your data
  • Your data is portable
  • Interfaces are simple, documented and platform agnostic
  • Access to your data while in service is unlimited not reliant on proprietary formats
  • Multiple infrastructure platform choices are available

Key Business requirements

  • Willing to sign a Business Associates Agreement ﴾if needed﴿
  • Service Level Agreement/Support contracts
  • Licensing details

No System is Perfect

  • Sometimes you may have to compromise on some of the aforementioned requirements
  • Be sure to mitigate the risks of not adhering to the requirements

5 Reasons to Use Open Source Software in Your Small Lab

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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.

Challenges to Consider

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.

Other Resources

  2. Open Source Initiative
  3. 10 Reasons Open Source is Good for Business
  5. Free Software Foundation

FDA Position of LDT Guidance Still Unclear

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.

Among the concerns addressed in the statement, a level playing field for traditional device manufacturers and independent laboratories referenced in the announcement.
While this news brings a little more clarity for the direction of lab-developed tests regulation by the FDA, the lack of a finalized guidance leaves the developers of LDTs, including In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) in limbo.

Quality Costs in Laboratory Information Systems

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.

Quality Costs in Software

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
  • Non-conformance costs

Conformance Costs

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

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:

  • Internal failure costs
  • External failure costs

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.

Cost of quality program

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.


  1. Knox, Stephen T. Modeling the Cost of Software Quality
  2. Ali Elbireer, MBA, MT(ASCP), CPHQ, Alicia R. Gable, MPH, J. Brooks Jackson, MD, MBA. Lab
  3. Douglas C. Wood. Principles of Quality Costs, Fourth Edition. 2012
  4. ASQ Quality Costs

FDA Will Now Require Electronic MDR submissions as of August 2015

In February 2014, the FDA submitted its final rule regarding updates to 21 CFR 803, Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities.  Up until now, manufactures and importers were able to submit a paper form, known as 3500A form, or an electronic equivalent.  Effective August 1 2015, electronic submissions will be the only acceptable format.  These submissions must be in HL7 format and sent to the FDA’s Electronic Submissions Gateway.  This will be a drastic change in the way MDR submissions occur for many organizations.  Luckily, the Administration has created a free desktop application that manufactures and importers can use to generate the HL7 files.  In addition, the FDA has created an API for organizations to use to turn their existing complaints management solutions into the HL7 format.  For more information, read on the FDA’s website here and here.