STS is happy to announce the upcoming release of :RATIO Version 4! The newest version of the powerful :RATIO solutions will be released in January 2012. The release introduces a totally re-designed front end to make your testing easier and more intuitive than ever before. A few of the new features include:
For Scenario: The ability to have up to 10 functions in each test case as well as the ability to identify Expected Failures. Now when you are doing negative testing or testing to ensure a warning message appears, the appearance of that warning signals success, and the test case goes to the Pass Report. If the warning is not displayed, the test case goes to the Review/Suspect Report.
For Blood Bank: Added support for Manufactured Products and the LINK function in Sunquest
For General Laboratory: Support for the LINK function and the ability to receive orders in from your HIS with just a patient’s medical record number.
To learn more, please contact us directly or connect with us via Twitter @stshealth.
A recent article in CAP TODAY states that "when it comes to protecting patients in the hospital, the presence or absence of a culture of safety can make a very tangible difference, one that can be measured in concrete units related to potential patient harm: error rates, length of stay, morbidity, and mortality."
Two members of the CAP Public Health Policy Committee, Michael B. Cohen, MD, and Emily E. Volk, MD, argue that pathologists should address patient safety as a whole, and consider that the role of clinical pathology in the overall patient experience affects safety more than many realize. In fact, "with about 70 percent of medical decisions being made on the basis of information from the laboratory, pathologists and other laboratory professionals are front and center in caring for patients." As a result of this, the responsibility of pathologists to be unyieldingly safe and accurate is "tremendous," says Dr. Volt, and pathologists are in a great position to advocate for investing in technology to help ensure patient safety.
To learn more about building a culture of patient safety in hospitals, and to read the original article, click here.
A recently published Institute of Medicine report commissioned by the Office of the National Coordinator for Health IT (ONC) recognizes the need and opportunity for building safer systems for health IT.
“It is important to recognize that health IT products generally cannot be installed out of the box. Users need to customize products judiciously to appropriately match their needs and capabilities – in both functionality and complexity of operation. The process of implementing software is critical to optimizing value and mitigating patient safety risks. A constant, ongoing commitment to safety – from acquisition to implementation and maintenance – is needed to achieve safer, more effective care. Testing at each of these stages is needed to ensure successful use of health IT.”
The report mentions the features of safer health IT, noting that a well tested, safely implemented health IT should “provide easy entry and retrieval of data, have simple and intuitive displays, and allow data to be easily transferred among health professionals.” This is often not the case, leaving problems like a poor user interface design, workflow issues, and complex data interfaces as significant patient safety issues.
Recommendations for improving technology development and design include standardized testing procedures and safety promotion funding from the ONC, as well as collaboration between the ONC, AHRQ, and health IT vendors to significantly reduce EHR-related patient risk. “Creating safer systems begins with user-centered design principles and continues with adequate testing and quality assessments conducted in actual and/or simulated clinical environments.”
For more information, and to read the original report, click here.
Dark Daily finds that medical laboratory accreditation and CLIA compliance are becoming increasingly more difficult. “One sign that laboratory accreditation and compliance is getting tougher is the increased number of hospital laboratories willing to publicly acknowledge that a recent assessment, survey, or inspection resulted in serious deficiencies.” Laboratory-Developed Tests – LDTs are a growing topic which has captured the attention of lab regulators and resulted in a lot of discussion, leading to a session at the Fifth Annual Lab Quality Confab titled: “The Dos and Don’ts of Validating a Laboratory-Developed Test to Meet Regulatory Requirements.”
For more information, and to read the original post, click here.
Preventable Medical Errors in the US Healthcare System
Most Americans would be shocked to learn the breadth and depth of preventable medical errors in the US healthcare system. The statistics are alarming. Did you know that:
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An average of almost 7,000,000 patients are harmed each year as a result of preventable medical errors
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Over 1,000,000 of these errors are medication based
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As a result of these medication based errors, approximately 5,000 patients die each year from a mistake that could have been prevented
To put that statistics in to perspective, think of it this way: eight fully loaded jumbo jets would have to crash every week to kill the same number of passengers as the number of patients who are accidentally killed in American hospitals. That gives the US healthcare system a safety record equal to that of motorcycle racing or bungee jumping.
Increasing Patient Safety with Technological Solutions
Our health care professionals are committed to providing the highest level of patient care, but the majority of these preventable medical errors could not have been solved by working harder or paying closer attention. We need help from technology to solve this problem.
So, in HIT, what are we doing to lower them? What are the best technological solutions for this problem? Solid CPOE implementations are a great start. According to the New England Healthcare Institute:
Implementing and Testing Your CPOE System
The catch here is proper implementation. A study done by the Leapfrog Group in 2010 showed that CPOE systems, on average, missed 50% of the routine medication order errors and 33% of the potentially fatal medication order errors. Thorough and exhaustive testing of our CPOE systems is the only way to get the much needed increase in patient safety. Attempting to manually test all the order combinations and evaluate the alerts is beyond what most institutions can do – there is simply not enough time nor resources. However, there is a solution. Tailored automated testing solutions deliver the ability to test 100% of your order catalog quickly and repeatedly – and much more accurately than manual testing. Automation delivers the peace of mind of a well tested system. And when your system is thoroughly tested and working as expected, you have the ability to make a significant difference in the world of preventable medical errors.
In today’s blog, I will begin discussing the elements of a computer systems validation. It’s important to remember that a computer system is more than just the software – although often times that’s where the bulk of effort is required. Keep in mind that a computer system is composed of the hardware and the software, along with a process system that is made up of the people, the procedures and the equipment used to perform a business function. All of these components need to be taken into consideration as each can have a significant impact on the system’s quality.
The first element we will start with is your Validation Procedure. The FDA recommends that your validation SOPs include, but not necessarily be limited to, the following:
• performing a risk assessment
• writing a validation plan
• writing a validation report
• addressing change control
• writing a test case
• amending a test case
• handling validation deviations
• validating after a change
• performing system maintenance
The level of confidence and, therefore, the level of validation effort needed, vary depending upon the functions of the system and how your site specifically uses those functions. Therefore, your test plan and test cases should be developed based on a site-specific risk assessment. A Risk Assessment is a process that consists of a system assessment combined with a measurement method (i.e. high, medium, low) that is used to identify the processes in the system that create the most risk to patient care or to the business if the process fails. The thought of doing a risk assessment scares many people, but the risk assessment process does not need to be complex. A simple risk assessment spreadsheet will work very well. Simply list the system functions and critical control points and then assign a risk value to each. This way you can quickly identify the processes with the most risk.
Examples of high risk activities for patient care include issue of ABO incompatible blood or release of a grossly inaccurate glucose result. While there is no patient risk for inaccurate or missing billing, there is significant business risk which should also be evaluated.
Be sure to revisit your risk assessment each time your system is updated so that new processes can be added as appropriate and the comparative risk can be re-evaluating.
Next time, we’ll talk about the Validation Plan itself.
Have you ever wondered just exactly what is a laboratory information systems (LIS) “validation” and if there really is a significant benefit to doing it other than simply to gain regulatory compliance? If so, you’re not alone. Both new LIS professionals and seasoned veterans have asked us many times if LIS validation is more than just a “necessary evil.” I believe the answer is a resounding YES. Through our first blog series, I will take you through the “who, what, where, why and how” of laboratory and blood bank validation. In the end, you will have a deeper understanding of the concept and intent and you‘ll be ready to draw your own conclusions.
Today, let’s start with the first part of “what” – exactly what is software validation? Simply put, it is the entire process of approving new software for use in your laboratory, blood bank or other hospital department and according to the FDA in its “Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility” document published in 2007, it should “assure that the software is suitable for your specific operations and workload, and can accurately and repeatedly meet your needs." The “your” part is critical here. Even though the LIS vendor has tested the software to the best of their ability, no two sites are using that LIS exactly the same way. No one’s test codes and blood products are exactly the same, no one’s workflows and processes are identical - and that is why every institution needs to thoroughly test their LIS – to ensure that is working as expected in your unique environment.
Many people think that "validation testing” and “software validation” are the same thing – they are not. Validation testing is just one of the components of a complete validation as defined by the FDA. A software validation requires a validation procedure, a risk assessment, a validation plan, a validation summary report and defined review/approval steps in addition to the actual validation testing. In the next blog, we’ll break down those validation elements in more detail and the value that each requirement brings to the table.
In the meantime, keep in mind that no one uses their LIS like you do and no one understands your SOPs as well as you, so you’re the only one that can truly validate your system and a well validated system will help ensure your patients’ safety.